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Content

Content
Introduction
Introduction 3

Pharmaceutical impurities
Background Certificate of Analysis List of products

11
13 15 21

European Pharmacopoeia
ATCC microbiological products Certified liquids for viscosity measurements International commission on pharmaceutical enzymes European Pharmacopoeia reagents WHO International Standards for Antibiotics

247
309 311 312 313 318

British Pharmacopoeia
ATCC microbiological products Pharmacope Franaise Pharmacopoeia Helvetica International Pharmacopeia

319
336 338 340 341

United States Pharmacopeia and National Formulary


ATCC microbiological products

347
422

Secondary standards Institute of Dyes and Organic products


Refractive index CRMs

425 431
434

Publications and subscriptions High purity solvents

435 439

Edition 2012/2013

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Introduction

Introduction
About LGC Standards
LGC Standards has successfully established a global reputation for the production of impurities and working standards, and as a single source for the supply of pharmacopeia reference materials. Our menu of custom services, including custom synthesis of impurities and metabolites, characterisation, certification, packaging and distribution, adds value to the scientific support we provide to our pharmaceutical customers. Our relationships with the worlds leading pharmacopoeias and their range of Chemical Reference Substances (CRS) and Reference Standards (RS), combined with in-house production of certified reference materials and pharmaceutical impurities, enable us to meet our customers specific needs. LGC Standards is also the exclusive European distributor for ATCC cultures and bio products. LGC Standards extensive network of sales offices and distribution centres means we offer the widest range of reference materials from one single source for rapid delivery. Our staff can provide scientific and technical guidance, including shipping and customs advice, in the local language. Our range of products also includes reference materials for clinical and forensic applications, phytochemicals, environmental analysis, physical properties determination, and food and beverage analysis. For more information about our range of services, or to receive any of our catalogues, please refer to our website www.lgcstandards.com or contact your local office.

About LGC
LGC Standards is part of LGC. LGC, whose Science and Technology Division acts as the designated UK National Measurement Institute (NMI) for Chemical and Biochemical measurement, has a long history in the development and validation of analytical methods and the production of reference materials. Many of the analytical methods, which cover the food, environment, industrial, clinical and pharmaceutical sectors, are accredited to ISO/IEC 17025 (Requirements for the competency of testing and calibration laboratories). Full details of the accreditation schedule can be found on the UKAS website (www.ukas.com). LGCs Science and Technology Division is accredited to ISO Guide 34 (General Requirements for the competence of reference materials producers) for the production of (certified) reference materials as is also our production site in Germany. The measurement capabilities used to produce certified reference materials in its capacity as the UK NMI are verified through participation on key comparison studies organised by the Consultative Committee for the Amount of Substance (CCQM) of the International Weights and Measures Organisation (BIPM). The certificates are recognised by other National Measurement Institutes, under the Mutual Recognition Arrangement. In its role as the NMI, LGC serves on the International Organisation for Standardisation (ISO) Committee for Reference Materials (REMCO), which aims to carry out and encourage a broad international effort for the harmonization, production and application of certified reference materials (CRMs).

About the catalogue


The 2012/2013 edition of the LGC Standards catalogue Pharmaceutical reference substances and impurities, replaces the Pharmaceutical reference substances and impurities 2011/2012 edition and the newsletter updates. The information provided in this catalogue as regards compendial articles is based on the official pharmacopoeial lists and is correct at the time of print. Original descriptions and spellings used by the producers are retained. In some cases additional information has been included to make the lists more convenient to use. The catalogue will be updated with three to four newsletters; these will be downloadable under www.lgcstandards.com. You can also contact your local LGC Standards office and ask to be provided with the newsletters once they are published.

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Edition 2012/2013

Pharmaceutical reference substances

Pharmaceutical reference substances


Certification
The products described in this catalogue include pharmacopeial reference substances for use in pharmaceutical analysis. Pharmacopeial CRSs and RSs should be distinguished from certified reference materials (CRMs), which are produced in conformity with the ISO guides 30 to 35, and supplied with a detailed certification document. Pharmacopeial reference substances are produced for a specific purpose, and the manufacturers follow rigorous protocols to ensure the reference substance is fit for the intended purpose. The certification processes follow the basic requirements of the relevant ISO REMCO guides, but are modified by the pharmacopoeias to reflect the particular demands of the associated pharmaceutical monograph. Details are given in the introduction to each section listing the various CRS collections in this catalogue.

Shelf Life, storage, expiry dates and unit sizes


Pharmacopeial CRSs and RSs should be purchased when required and not stored for a prolonged period. Pack sizes are designed to allow a limited number of replicate analyses, as required by Good Analytical Practice, but the opened pack should not be kept for future use. Please check all individual storage temperature requirements and note that the substances should be kept away from humidity and light (unless otherwise stated). Specific lot numbers or letters are allocated to all pharmacopeial reference substances, but no expiry dates are set. New lots are normally prepared well in advance of the expected "sell-out" of the current lot. Please note, that new lots can have different unit sizes, especially with pharmacopoeial reference standards, and LGC Standards is not responsible for such cases. If the unit size of a new batch changes, LGC Standards will provide this information to customers in new lot lists. When a substance is withdrawn from sale because the lot has depleted a final expiry date is given, by which any material from the outgoing lot held by users must be used. This means that for a period of time both lots are official. Lot information is provided by USP and EP in their literature and is available from LGC Standards. If a material is withdrawn by the producer, then all stocks held by the users are no longer valid and have to be destroyed. Should this occur, LGC Standards will inform all customers who have purchased the withdrawn substance. Please note that such a situation is outside LGC Standards control and products are not refundable. Once opened, LGC Standards and the pharmacopoeias can no longer guarantee the stability of the material and any of the CRS/BRP and RS not used should be disposed of and not kept for future use.

Impurity standards
Impurities in a pharmaceutical substance can change the effects and side effects of a drug significantly. Therefore, it is important to have an accurate detection of impurities. The pharmaceutical monographs regulate the legal definition, the analysis and the limits of impurities of a given substance. An official range of impurity standards is available from the main pharmacopoeias where a CRS or RS is required in the monograph. Over 2800 other impurity standards are listed in the pharmaceutical impurities section of this catalogue. These materials are produced by LGC, whose Science & Technology Division acts as the designated UK National Measurement Institute for Chemical and Biochemical Measurements. They are produced at our facility in Luckenwalde near Berlin, Germany and are supplied with a certificate of analysis. Our impurity reference standards are intended for the identification and control of impurities in drug substances and drug preparations, as well as for method development and validation.

Controlled substances
A number of the pharmaceutical substances, such as narcotics and tranquillisers, described in this catalogue are Controlled Substances in their country of origin and are marked Controlled Substance against the product description. The purchase, possession and use of Controlled Substances are subject to national and international regulations designed to limit their abuse. It is the responsibility of the customer to obtain any authorisation necessary to both purchase and possess Controlled Substances, complying with the laws of the importing country, before ordering. Customers wishing to obtain Controlled Substances must contact their LGC Standards sales office before ordering, and clarify with the sales specialists the relevant national requirements, the associated charges and consequential delivery times. All orders for Controlled Substances must be provided in writing and signed by an authorised person. The orders must be accompanied with the original import permit and/or possession permit.

Edition 2012/2013

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Pharmaceutical reference substances Use, safety and handling


Please read any documents supplied with the product before opening or using it. Particular attention must be paid to instructions referring to pre-mixing, addition of diluent to lyophilised materials and to the minimum size of sample to be used. The latter point is particularly important as it has normally been set by the producer after considering fully the homogeneity testing data obtained as a part of the certification exercise. The use of smaller than recommended samples is one of the most common sources of error. Some pharmaceutical substances are toxic and require special handling. Virtually all pharmaceutical reference substances have a pharmacological and/or biological activity. We therefore recommend that all the products described in this catalogue should be handled as if they were bio-active, toxic or infective, and that opened packs should only be handled by trained laboratory personnel. We also strongly recommend to read the information provided by material safety data sheets coming with our impurity reference standards and the reference standards from major pharmacopoeias. All pharmaceutical reference substances and standards are for laboratory analytical use only and not for use in humans.

General ordering information


Prices and delivery procedures are described in the price list that accompanies this catalogue, or are available from your local LGC Standards office. For products requiring special delivery procedures (cooled shipping, special licensing, Controlled Substances) additional charges may be applied. Please note that once delivered to the customer, reference substances are not returnable. Customers requiring assistance with the purchase, use or application of a particular reference substance should contact LGC Standards where technical staff are available to advise on the use and suitability of the products.

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Edition 2012/2013

Pharmaceutical impurities

Pharmaceutical impurities
Background
The pharmacopeial monographs regulate the legal definition but also the analysis and the limits of impurities in a given substance. Impurities in a pharmaceutical substance can change the effects and side effects of a drug significantly. It is therefore important to have an accurate detection of impurities. The increasing importance of impurity reference materials is also becoming apparent in the registration of drugs, where an exact identification and quantification of susceptible impurities is required for an assured documentation. A wide range of known impurities is listed in individual pharmacopeial monographs. However, by far not all of these standards are available from the pharmcopoeias. The impurity standards listed below from LGC are filling this gap to a large extent. Guidelines and limits for impurities have been laid out in compendial monographs, in specifications from the manufacturer internally or in the International Conference on Harmonisation (ICH) Guidelines which have been agreed by Europe, Japan and the United States. The ICH conducted four guidelines on impurity issues: ICH Q3A (R1): Impurities in New Drug Substances ICH Q3B (R2): Impurities in New Drug Products ICH Q3C (R5): Impurities: Guideline for Residual Solvents ICH Q3D: Impurities: Guideline for Metal Impurities. The full wording of the ICH guidelines is available at the official website of the ICH: www.ich.org. The ICH guidelines on impurities were originally developed for new, original drug substances and products. However, it is now commonly agreed in the three ICH regions by FDA, EMA and Japanese regulation documents that these guidelines need to be applied to generic compounds as well, in addition to the pharmacopoeial monographs.

About LGC
The pharmaceutical impurities listed in this section are produced by LGC, whose Science & Technology Division acts as the designated UK National Measurement Institute for Chemical and Biochemical Measurements. LGC is an independent, science-based service company providing chemical, biochemical and DNA based analytical and diagnostic services, and reference standards. As Europe's largest, independent analytical laboratory, LGC's services include analytical testing, research, consultancy, validation, training and knowledge transfer. LGC Standards, a division of LGC, provides the most comprehensive source of certified reference materials and standards, pharmaceutical reference substances and impurities, biomaterials, cell lines and high purity solvents to the scientific community worldwide. LGC Standards has successfully established a global reputation for the production of impurities and working standards, and as a single source for the supply of pharmacopeia reference materials. Our menu of custom services, including custom synthesis of impurities and metabolites, characterisation, certification, packaging and distribution, adds value to the scientific support we provide to our pharmaceutical customers. For more information about these services, please contact your local LGC Standards office.

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Pharmaceutical impurities Certification


Each product is accompanied by a detailed certificate of analysis, which gives information on the identity and purity, together with the various analytical methods and their conditions. A sample of such a certificate is printed on the following pages. In the past, we received some inquiries from a few customers wondering why there is no declaration on the certificates of analysis (CofA) for LGC products stating that the substances are fulfilling the specifications for reagents, as described for example in chapter 4 of the European Pharmacopeia. The LGC impurity standards are thoroughly tested chemical reference substances and are used for reliable identification and quantification of impurities in pharmaceutical ingredients and products. They are also valuable tools for spiking experiments during validation studies of specificity and accuracy of analytical methods. The abbreviations EP, Pharmeuropa, BP and USP in the article description are indicating that the particular substance is mentioned as an impurity in that particular compendial publication. They do not indicate that certain specification of reagents or drug substances mentioned in the publications are fulfilled. The standards where they are actually listed as reagents or drug substances may fulfill this specification, but this is not the intention and is not certified on the CofA. The production of our 2800+ LGC impurities reference standards follows the principles of ISO Guide 34 "General requirements for the competence of reference materials producers". This applies to new products and new batches of already existing products. In combination with ISO 17025, the ISO Guide 34 principles provide the best approach to the production of reference materials.

Narcotics and drug precursors


Some of the substances described in this section are subject to narcotics respective drug precursors legislation. These are marked as [Controlled Substance] or [Drug Precursor], respectively. Please contact your local LGC Standards office for information on the legal requirements in order to purchase these products.

Delivery time
The majority of products mentioned in this section are available from stock; others may have a delivery time of approximately four weeks. For substances marked with "on request", longer delivery times may apply. For custom synthesis, the time is estimated from previous experience. Customers will be notified if unforeseen complications arise during the synthesis. In the unlikely event that a synthesis does not reach the expected result, LGC Standards reserves the right to cancel the order.

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Pharmaceutical impurities
Code Product Price Unit

4-Aminobenzoic Acid
MM 0094.00 Imp. B (EP): Benzocaine
H2N O O

(A)

500 mg

MM 0093.17

Imp. C (EP) as Hydrochloride: Aniline Hydrochloride


H2N

x HCl

(B)

100 mg

Acebutolol Hydrochloride
MM 0435.00 Acebutolol Hydrochloride
O N H O O OH H N

(A)

500 mg

x HCl

MM 0435.01

Imp. A (EP): N-[3-Acetyl-4-[(2RS)-oxiran2-ylmethoxy]phenyl]butanamide

O O N H O O

(A)

50 mg

MM 0435.02

Imp. B (EP) as Hydrochloride:N-[3-Acetyl-4-[(2RS)2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetamide Hydrochloride (Diacetolol Hydrochloride) Imp. C (EP): N-(3-Acetyl-4-hydroxyphenyl)butanamide

O O N H O

OH

H N

(A)
x HCl

100 mg

MM 0435.03

O O N H OH

(A)

100 mg

MM 0435.04

Imp. D (EP) as Hydrochloride: 1-[5-Amino-2[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]ethanone Dihydrochloride


H2N

O O

OH

H N

(A)
x 2 HCl

50 mg

MM 0435.05

Imp. E (EP) as Hydrochloride: N-[4-[(2RS)-2Hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]butanamide Hydrochloride Imp. F (EP): N-[3-Acetyl-4-[(2RS)2,3-dihydroxypropoxy]phenyl]butanamide

OH O N H O

H N

(A)
x HCl

50 mg

MM 0435.06

O O N H O

OH OH

(A)

50 mg

MM 0435.07

Imp. G (EP): N,N'-[[(1-Methylethyl)imino]bis[(2-hydroxypropane-1,3-diyl)oxy(3-acetyl1,4-phenylene)]]dibutanamide (Acebutolol Biamine) Imp. H (EP): N,N'-[(2-Hydroxypropane1,3-diyl)bis[oxy(3-acetyl-1,4-phenylene)]]dibutanamide

O O HN O

OH N

OH O

(A)

50 mg

NH O

MM 0435.08

O O HN O

OH O

(A)

50 mg

NH O
O O N H O OH H N

MM 0435.09

Imp. I (EP): N-[3-Acetyl-4-[(2RS)-3-(ethylamino)2-hydroxypropoxy]phenyl]butanamide

(A)

50 mg

MM 0435.10

Imp. J (EP) as Hydrochloride: N-[3-Acetyl-4[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]propanamide Hydrochloride Imp. K (EP) as Hydrochloride: N-[3-Butanoyl4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]butanamide Hydrochloride

O O N H O

OH

H N

(A)
x HCl

50 mg

MM 0435.11

O O N H O

OH

H N

(A)
x HCl

50 mg

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21

Pharmaceutical impurities
Code Product Price Unit

Aceclofenac
MM 0181.00 Aceclofenac
O NH Cl Cl O O OH

(A)

250 mg

MM 0006.20

Imp. A (EP): [2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid (Diclofenac)


Cl

OH O NH Cl

(A)

100 mg

MM 0006.10

Imp. B (EP): Methyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Methyl Ester of Diclofenac)


Cl

O O NH Cl

(A)

100 mg

MM 0006.11

Imp. C (EP): Ethyl 2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetate (Ethyl Ester of Diclofenac)


Cl

O O NH Cl

(A)

100 mg

MM 0181.01

Imp. D (EP): Methyl [[[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]oxy]acetate (Methyl Ester of Aceclofenac)


Cl

O O O NH Cl O

(A)

100 mg

MM 0181.02

Imp. E (EP): Ethyl [[[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]oxy]acetate (Ethyl Ester of Aceclofenac)


Cl

O O O NH Cl O

(A)

100 mg

MM 0181.03

Imp. F (EP): ): Benzyl[[[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]oxy]acetate (Benzyl Ester of Aceclofenac)


Cl

O O O NH Cl O

(A)

100 mg

MM 0181.04

Imp. G (EP): [[[[[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetic Acid (Acetic Aceclofenac)


Cl

O O O NH Cl O O OH

(A)

100 mg

MM 0181.05

Imp. H (EP): [[[[[[[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic Acid (Diacetic Aceclofenac)

O O O NH Cl Cl O O O

O OH

(A)

50 mg

MM 0006.01

Imp. I (EP):1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one
N Cl

O Cl

(A)

100 mg

MM 0181.06

Isopropyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Isopropyl Ester of Diclofenac)


Cl

O O NH Cl

(A)

100 mg

Acesulfame Potassium
MM 1093.01 Imp. A (EP): 3-Oxobutanamide (Acetylacetamide)
O NH2 O

(A)

100 mg

Acetazolamide
MM 0648.00 MM 0648.04 Acetazolamide
O H N S N N O O S NH2

(A) (A)

500 mg 50 mg

Imp. A (EP): N-(5-Chloro-1,3,4-thiadiazol-2-yl)acetamide

Cl

S N N

H N O

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Pharmaceutical impurities
Code Product Price
S N N H N O

Unit

MM 0648.01

Imp. B (EP): N-(1,3,4-Thiadiazol-2-yl)acetamide

(A)

50 mg

Acetylcysteine
MM 0024.00 N-Acetyl-L-cysteine
HS HN O O OH

(A)

500 mg

MM 0024.03

Imp. A (EP): L-Cystine

NH2 HO O S S

O OH NH2
O HS NH2 OH

(B)

100 mg

MM 0024.02 MM 0024.04

Imp. B (EP): L-Cysteine Imp. C (EP): N,N-Diacetyl-L-cystine


HO O

(B) (A)

100 mg 100 mg

O NH S S HN O O OH

MM 0024.01

Imp. D (EP): N,S-Diacetyl-L-cysteine

O S HN

O OH O

(A)

100 mg

MM 0024.05

Sodium 2-Methyl-4,5-dihydro-1,3-thiazol-4-carboxylate

O N S ONa

(A)

100 mg

MM 0024.06

N-Propionyl-L-cysteine
HS HN

O OH

(A)

100 mg

Acetylsalicylic Acid
MM 0133.00 Acetylsalicylic Acid
O HO O O

(A)

500 mg

MM 0045.01

Imp. A (EP): 4-Hydroxybenzoic Acid


HO

(B)
OH

100 mg

MM 0045.02

Imp. B (EP): 4-Hydroxybenzene-1,3-dicarboxylic Acid (4-Hydroxyisophthalic Acid) Imp. C (EP): Salicylic Acid

O HO

O OH OH

(A)

100 mg

MM 0045.00

O OH OH

(A)

500 mg

MM 0133.01

Imp. D (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid (Acetylsalicylsalicylic Acid)


O

O OH O O O

(A)

100 mg

MM 0133.03

Imp. E (EP):2-[(2-Hydroxybenzoyl)oxy]benzoic Acid (Salicylsalicylic Acid)


O

O OH O OH

(A)

100 mg

MM 0133.02

Imp. F (EP): 2-(Acetyloxy)benzoic Anhydride (Acetylsalicylic Anhydride)

O O O O O O O

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
O OH O OH

Unit

MM 0133.04

2-(2,4-Dihydroxybenzoyl)benzoic Acid

(A)

100 mg

OH

MM 0133.08

4-Acetoxyisophthalic Acid
HO

O OH O O

(A)

50 mg

MM 0133.09

Acetylsalicylsalicylsalicylic Acid

O OH O O O O O O

(A)

50 mg

N-Acetyltryptophan
MM 1267.01 Imp. A (EP): Tryptophan
H N NH2 OH O

(A)

100 mg

MM 0172.03

Imp. D (EP): (S)-2-Amino-3-(5-hydroxy1H-indol-3-yl)propanoic Acid (5-Hydroxy-tryptophan)


HO

H N

NH2 OH O

(A)

100 mg

Aciclovir
MM 0061.00 Aciclovir
HN H2 N N O N N O OH

(A)

500 mg

MM 0061.01

Imp. A (EP): 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin9-yl)methoxy]ethyl Acetate


H2N

O HN N N O N O O

(A)

100 mg

MM 0061.02

Imp. B (EP): 2-Amino-1,7-dihydro-6H-purin-6-one (Guanine)


H2N

O HN N
O N N N

H N N
OH

(B)

100 mg

New MM 0061.03

Imp. C (EP): 2-Amino-7-[(2-hydroxyethoxy)methyl]-1,7-dihydro-6H-purin6-one Aciclovir Imp. D (EP): 2-[(2-Amino-6-oxo-1,6-dihydro9H-purin-9-yl)methoxy]ethylBenzoate


H2N

O HN H2N

(A)

100 mg

MM 0061.04

O HN N N O N O
O O N H HN N
O O HN N H N N N O O O

(A)
O

100 mg

MM 0061.06

Imp. F (EP): N-[9-[(2-Hydroxyethoxy)methyl]-6-oxo6,9-dihydro-1H-purin-2-yl]acetamide

(A)
N OH N O

100 mg

MM 0061.07

Imp. G (EP): 2-[[(2-(Acetylamino)-6-oxo-1,6-dihydro9H-purin-9-yl]methoxy]ethyl Acetate Aciclovir Imp. H (EP): 2-[[2-(Acetylamino)-6-oxo1,6-dihydro-9H-purin-9-yl]methoxy]ethyl Benzoate

(A)

100 mg

MM 0061.08

O O N H HN N N O N O
Cl N Cl N N N H

(A)
O

100 mg

MM 0061.10

2,6-Dichloropurine

(B)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Adapalene
MM 0681.03 Imp. A (EP): 2,2'-Binaphthalene-6,6'-dicarboxylic Acid
HO O

(A)

50 mg

OH O

MM 0681.01

Imp. C (EP): 1-(2-Methoxyphenyl)tricyclo3,7 [3.3.1.1 ]decane Imp. D (EP): 1,1'-[4,4'Bis(methoxy)biphenyl-3,3'3,7


O

(A)

50 mg

New MM 0681.02

(A)
O

50 mg

diyl]bis(tricyclo[3.3.1.1 ]decane)

Adenosine
MM 0784.00 Adenosine
N HO N O NH 2 N N

(A)

500 mg

OH OH

MM 0784.01

Imp. A (EP) as Sulphate: 7H-Purin-6-amine Sulphate (Adenine Sulphate)

NH2 N N N N H x H2SO4 2

(A)

100 mg

MM 0784.02

Imp. F (EP): 1--D-Ribofuranosylpyrimidine2,4(1H,3H)-dione (Uridine)


HO

O HN O O N

(A)

100 mg

OH OH

MM 0784.03

Imp. G (EP): 9--D-Ribofuranosyl-1,9-dihydro6H-purin-6-one (Inosine)

O HN HO N O N N

(A)

100 mg

OH OH

MM 0784.04

Imp. H (EP): 2-Amino-9--D-ribofuranosyl1,9-dihydro-6H-purin-6-one (Guanosine)

O HN H2N HO N O N N

(A)

100 mg

OH OH

Adiphenine Hydrochloride
MM 1172.00 Adiphenine Hydrochloride
O O N x HCl

(A)

250 mg

Adrenaline Tartrate
MM 0614.00 Adrenaline Tartrate
HO OH OH H N x HO O OH OH OH O OH

(A)

500 mg

MM 0614.02

L-Adrenaline
HO OH

H N

(A)

500 mg

MM 0614.13

Imp. C (EP) as Hydrochloride: 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanone Hydrochloride (Adrenalone Hydrochloride)

O HO HO

H N

(A)
x HCl

100 mg

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25

Pharmaceutical impurities
Code Product Price
SO 3 H H N

Unit

MM 0614.01

(1R)-1-(3,4-Dihydroxyphenyl)-2-methylaminoethanesulphonic Acid (Adrenaline -Sulphonate)


HO OH

(A)

100 mg

Alanine
MM 0566.00 Alanine
NH2 OH O

(A)

500 mg

Albendazole
MM 0382.00 Albendazole
S H N N O O NH

(A)

500 mg

MM 0382.01

Imp. A (EP): 5-(Propylsulphanyl)-1H-benzimidazol-2-amine


S

H N NH2 N
H N S O N O O NH

(A)

100 mg

MM 0382.02

Imp. B (EP): Methyl [5-Propylsulphinyl)-1H-benzimidazol2-yl]carbamate Imp. C (EP): Methyl [5-Propylsulphonyl)-1H-benzimidazol2-yl]carbamate


S O O

(A)

100 mg

MM 0382.03

H N N

O O NH

(A)

100 mg

MM 0382.04

Imp. D (EP): 5-(Propylsulphonyl)-1H-benzimidazol-2-amine


O S O

H N N NH2

(A)

100 mg

MM 2500.00

Imp. E (EP): Methyl (1H-Benzimidazol-2-yl)carbamate (Carbendazim)

H N N

O O NH

(A)

100 mg

Alfuzosin Hydrochloride
MM 0085.04 Imp. B (EP): 2-Chloro-6,7-dimethoxyquinazolin-4-amine
O O N N NH2 Cl

(A)

100 mg

MM 1004.04

Imp. D (EP) as Dihydrochloride: N-(4-Amino-6,7-dimethoxyquinazolin-2-yl)N-methylpropane-1,3-diamine Dihydrochloride

O O

N N NH2

NH2 x 2 HCl

(A)

50 mg

Allobarbital
MM 0899.00 Allobarbital [Controlled Substance]
O H N O NH O

(A)

100 mg

Allopurinol
MM 0034.00 Allopurinol
N N H N O NH

(A)

500 mg

MM 0034.01

Imp. A (EP) as Hemisulphate: 5-Amino-1H-pyrazole4-carboxamide Hemisulphate Imp. D (EP): Ethyl 5-Amino1H-pyrazole-4-carboxylate

O N N H NH2 NH2 O N N H O NH2 O N N H N H O N N H N H NH O O O x 1/2 H2SO4

(A)

100 mg

MM 0034.05

(A)

100 mg

MM 0034.06

Imp. E (EP): Ethyl 5-(Formylamino)-1H-pyrazole-4-carboxylate

(A)

100 mg

MM 0034.07

Oxypurinol

(A)

100 mg

26

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Pharmaceutical impurities
Code Product Price Unit

Alprazolam
New MM 0136.00 Alprazolam [Controlled Substance]
N Cl N N N

(A)

100 mg

MM 0028.03

Imp. E (EP): (2-Amino-5-chlorophenyl)phenylmethanone


Cl

NH2 O

(B)

100 mg

Alverine Citrate
MM 0454.00 Alverine Citrate
N x O OH OH O OH OH O

(A)

250 mg

MM 0454.02 MM 0454.03 MM 0454.04 MM 0454.05

Imp. A (EP): 1-Chloro-3-phenyl-propane


Cl

(A) (A)
OH x HCl

100 mg 100 mg 100 mg 100 mg

Imp. B (EP): 3-Phenylpropan-1-ol Imp. C (EP) as Hydrochloride: N-Ethyl3-phenylpropan-1-amine Hydrochloride Imp. D (EP) as Hydrochloride: N-(3Cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine Hydrochloride Imp. E (EP) as Hydrochloride: 3-PhenylN,N-bis(3-phenylpropyl)propan-1-amine Hydrochloride
N

(A) (A)

NH

x HCl

MM 0454.06

(A)
x HCl

100 mg

Amantadine Hydrochloride
MM 0564.00 Amantadine Hydrochloride
NH2 x HCl

(A)

500 mg

Ambroxol Hydrochloride
MM 0005.00 Ambroxol Hydrochloride
Br N H NH2 Br OH x HCl

(A)

500 mg

MM 0005.01

Imp. A (EP): (2-Amino-3,5-dibromophenyl)methanol

Br

OH NH2 Br

(A)

100 mg

MM 0005.04

Imp. B (EP) as Hydrochloride: trans-4-(6,8-Dibromo1,4-dihydroquinazolin-3(2H)-yl)cyclohexanol Hydrochloride

OH Br N H OH Br N NH2 Br N Br x HCl

(A)

100 mg

MM 0005.03

Imp. C (EP): trans-4-[[(E)-2-Amino3,5-dibromobenzyliden]amino]cyclohexanol

(A)

100 mg

MM 0005.05

Imp. D (EP) as Hydrochloride: cis-4-[(2-Amino3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride

OH Br N H NH2 Br x HCl

(A)

100 mg

MM 0005.02

Imp. E (EP): 2-Amino-3,5-dibromobenzaldehyde

Br

O NH2 Br

(A)

100 mg

MM 0005.06

trans-4-Aminocyclohexanol Hydrochloride
H2 N

OH x HCl

(A)

100 mg

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27

Pharmaceutical impurities
Code Product Price
OH x HCl H2 N

Unit

MM 0005.07

cis-4-Aminocyclohexanol Hydrochloride

(A)

100 mg

Amfetamine Sulfate
New MM 0741.00 Amfetamine Sulfate [Controlled Substance]
NH2 x H2SO4 2

(A)

100 mg

Amiloride Hydrochloride
MM 0560.00 Amiloride Hydrochloride Dihydrate
O Cl H2N N N N H NH2 NH NH2 x HCl x 2 H2O

(A)

500 mg

Aminocaproic Acid
MM 0896.00 Aminocaproic Acid
O H 2N OH

(A)

500 mg

Amiodarone Hydrochloride
MM 0697.00 Amiodarone Hydrochloride
O O I N O I x HCl

(A)

250 mg

MM 0697.11

Imp. A (EP) as Oxalate: (2-Butylbenzofuran-3-yl)[4-[2-(diethylamino)ethoxy]phenyl]methanone Oxalate Imp. B (EP) as Hydrochloride: (2-Butylbenzofuran3-yl)[4-[2-(ethylamino)ethoxy]-3,5diiodophenyl]methanone Hydrochloride (Desethylamiodarone Hydrochloride) Imp. C (EP) as Hydrochloride: (2-Butylbenzofuran3-yl)[4-[2-(diethylamino)ethoxy]3-iodophenyl]methanone Hydrochloride Imp. D (EP): (2-Butylbenzofuran-3-yl) (4-hydroxy-3,5-diiodophenyl)methanone

O HO O O N x HO O O

(A)

100 mg

MM 0697.03

O I O O I H N x HCl

(D)

100 mg

MM 0697.04

O I O O N x HCl

(A)

100 mg

MM 0697.05

O I O OH I

(A)

100 mg

MM 0697.06

Imp. E (EP): (2-Butylbenzofuran3-yl)(4-hydroxyphenyl)methanone

O O OH

(A)

100 mg

MM 0697.07

Imp. F (EP): (2-Butylbenzofuran-3-yl)(4-hydroxy3-iodophenyl)methanone

O I O OH

(A)

100 mg

MM 0697.09

Imp. H (EP) as Hydrochloride: 2-Chloro-N,N-diethylethanamine Hydrochloride (2-Chlorotriethylamine Hydrochloride; (2-Chloroethyl)diethylamine Hydrochloride) Amiodarone N-Oxide Hydrochloride
O O

Cl

x HCl

(C)

100 mg

MM 0697.10

I O I N O x HCl

(A)

100 mg

Amisulpride
MM 0051.01 Imp. A (EP): [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine
H2N N

(A)

100 mg

New MM 0793.02

Imp. B (EP): 4-Amino-N-[[(2RS)-1-ethylpyrrolidin-2-yl]methyl]-5-(ethylsulphonyl)2-hydroxybenzamide

O O S H2N

O N H OH

(A)
N

50 mg

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Pharmaceutical impurities
Code Product Price
O I H2N O O N H O
O O S H2N

Unit

MM 0793.03

Imp. C (EP): 4-Amino-N-[[(2RS)-1-ethyl-pyrrolidin2-yl]methyl]-5-iodo-2-methoxy-benzamide

(A)
N H N

50 mg

MM 0793.04

Imp. D (EP): 4-Amino-N-[[(2RS)-1-ethyl-pyrrolidin-2-yl]methyl]2-methoxy-5-(methylsulphonyl)benzamide

O O S H2N

(A)
N

50 mg

MM 0793.05

Imp. E (EP): 4-Amino-5-(ethylsulphonyl)2-methoxybenzoic Acid

O OH O

(A)

100 mg

Amitraz
MM 1018.01 MM 1018.02 Imp. A (BP): 2,4-Dimethylaniline (2,4-Xylidine) Imp. B (BP): Form-2',4'-xylidide
H N

NH2

(A) (A)

100 mg 100 mg

Amitriptyline Hydrochloride
MM 0062.00 Amitriptyline Hydrochloride
N x HCl

(A)

500 mg

MM 0062.01

Imp. A (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-one (Dibenzosuberone)

(B)
O

100 mg

MM 0062.02

Imp. B (EP) as Hydrochloride: 3-(5H-Dibenzo[a,d][7] annulen-5-ylidene)-N,N-dimethylpropan-1-amine Hydrochloride (Cyclobenzaprine Hydrochloride)

(A)
N x HCl

100 mg

MM 0079.00

Imp. C (EP) as Hydrochloride: 3-(10,11-Dihydro-5Hdibenzo[a,d][7]annulen-5-ylidene)-N-methylpropan-1amine Hydrochloride (Nortriptyline Hydrochloride)

(A)
N H x HCl

500 mg

MM 0062.03

Imp. D (EP): 5-[3-(Dimethylamino)propyl]-10,11-dihydro-5Hdibenzo[a,d][7]annulen-5-ol

(A)
OH N

100 mg

MM 0062.05

Imp. F (EP): (5EZ,10RS)-5-[3-(Dimethyl-amino)propylidene]10,11-dihydro-5H-dibenzo[a,d][7]annulen-10-ol


HO

(A)

100 mg

MM 0062.14

Imp. G (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ol (Dibenzosuberol)

(A)
OH

100 mg

MM 0062.12

Amitriptyline N-Oxide Hydrochloride


N O x HCl

(B)

10 mg

MM 0062.13

10,11-Dihydro-5H-dibenzo[a,d]cycloheptene (Dibenzosuberane)

(A)

100 mg

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29

Pharmaceutical impurities
Code Product Price Unit

Amlodipine Besilate
MM 0383.00 Amlodipine Besilate
O O O Cl H N O O NH 2 O O S OH

(D)

100 mg

MM 0383.06

Amlodipine
O O

H N

O O O Cl

NH2

(A)

100 mg

MM 0383.01

Imp. A (EP): 3-Ethyl-5-Methyl (4RS)-4-(2-Chlorophenyl)2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethoxy]methyl]6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

O H N O O O Cl O O N O

(D)

100 mg

MM 0383.02

Imp. B (EP): 3-Ethyl 5-Methyl (4RS)4-(2-Chlorophenyl)-6-methyl2-[[2-[[2-(methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate Ethyl Methyl (4RS)-2,6-Bis[(2-aminoethoxy)methyl]4-(2-chlorophenyl)-1,4-dihydropyridine3,5-dicarboxylate Dihydrochloride

H N O O O Cl

O O

H N

O N H

(D)

100 mg

MM 0383.03

H2N

O O O

H N

O O O Cl

NH2

(D)

100 mg

x 2 HCl
NH2

MM 0383.04

Imp. D (EP): 3-Ethyl-5-Methyl 2-[(2-Aminoethoxy)methyl]4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate

N O O O Cl

O O

(D)

100 mg

MM 0383.10

Imp. E (EP): Diethyl (4RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6methyl-1,4-dihydropyridine-3,5-dicarboxylate

H N O O O Cl

O O

NH2

on request

MM 0383.09

Imp. F (EP): Dimethyl (4RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6methyl-1,4-dihydropyridine-3,5-dicarboxylate

H N O O O Cl

O O

NH2

(D)

100 mg

MM 0383.07

Imp. G (EP): Dimethyl 4-(2-Chlorophenyl)2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

H N O O O Cl O

(A)

100 mg

MM 0383.11

Imp. H (EP): 2-[[2-[[(4RS)-4-(2-Chlorophenyl)3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl]carbamoyl]benzoic Acid

H N O O O Cl

O O

H N O O OH

(D)

100 mg

MM 0383.05

Benzenesulfonic Acid

O O S OH

(B)

100 mg

Amlodipine Maleate
MM 0631.00 Amlodipine Maleate
O O O Cl H N O O NH2 x O O OH OH

(D)

100 mg

30

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Pharmaceutical impurities
Code Product Price Unit

Amlodipine Mesilate
MM 0592.00 Amlodipine Mesilate
O O O Cl H N O O x NH2 O O S

(D)

100 mg

HO

Amobarbital
New MM 1353.00 Amobarbital [Controlled Substance]
O H N O NH O

(A)

100 mg

Amodiaquine Dihydrochloride Dihydrate


MM 0617.00 Amodiaquine Dihydrochloride Dihydrate
Cl N N HN OH x 2 HCl x 2 H2O

(A)

500 mg

MM 0617.01

4-Acetamido-2-diethylaminomethylphenol
H N O N

(A)

100 mg

OH N

MM 0617.02

7-Chloro-4-(4-hydroxyphenylamino)quinoline

Cl

(A)

100 mg

HN OH

MM0617.03

4,7-Dichloroquinoline

Cl

(C)

100 mg

Cl

MM 0617.04

Monodesethylamodiaquine Dihydrochloride

Cl

N HN HN OH

(A)
x 2 HCl

100 mg

Amoxicillin Trihydrate
MM 0232.00 Amoxicillin Trihydrate
O NH 2 H N N S H
O O N H2N S H
O O NH2 H N N S H OH

OH

(A)
x 3 H2O

500 mg

HO

MM 0026.04

Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) Imp. B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino-2(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane2-carboxylic Acid (L-Amoxicillin)
HO

OH

(B)

100 mg

MM 0232.02

(D)

100 mg

MM 0232.03

Imp. C (EP): (4S)-2-[5-(4-Hydroxyphenyl)3,6-dioxopiperazin-2-yl]-5,5-dimethyl-thiazolidine4-carboxylic Acid (Amoxicillin Diketopiperazines)


HO

O HN S O

OH

(A)

100 mg

H N N H

MM 0232.04

Imp. D (EP) as Sodium Salt:(4S)-2-[[[(2R)-2-Amino2-(4-hydroxyphenyl)acetyl]amino]carboxymethyl]5,5-dimethylthiazolidine-4-carboxylic Acid Sodium Salt (Penicilloic Acids of Amoxicillin Sodium Salt)
HO

O NH 2 HN S O

ONa

(A)

100 mg

H N

O HO

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31

Pharmaceutical impurities
Code Product Price
O NH 2 HN S OH

Unit

MM 0232.05

Imp. E (EP): (2RS,4S)-2-[[[(2R)-2-Amino2-(4-hydroxyphenyl)acetyl]amino]methyl]5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Amoxicillin)


HO

(A)

50 mg

H N

O
HO N N HO

MM 0232.06

Imp. F (EP): 3-(4-Hydroxyphenyl)pyrazin-2-ol

(A)

100 mg

New MM 0232.07

Imp. G (EP): (2S,5R,6R)-6-[[(2R)-2-[[(2R)-2Amino-2-(4-hydroxyphenyl)acetyl]amino]-2(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2carboxylic Acid (D-(4-Hydroxyphenyl)glycylamoxicillin) Imp. H (EP): (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2(4-hydroxyphenyl)acetic Acid

NH2 O O HO NH H N N

(A)
OH

100 mg

S H

HO

MM 0232.08

O NH OH HO O
NH 2 OH HO O
NH2 NH2 HO O

(A)

100 mg

MM 0232.09

Imp. I (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid

(B)

100 mg

MM 0232.12

(2R)-2-Amino-2-(4-hydroxy-phenyl)-acetamide

(A)

100 mg

Ampicillin Sodium
MM 0253.00 Ampicillin Sodium
O NH2 H N N S H
O O NH 2 H N N S H x 3 H2O

ONa

(A)

500 mg

MM 0253.15

Ampicillin Trihydrate

OH

(A)

500 mg

MM 0026.04

Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) Imp. B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino2-phenylacetyl]amino]-3,3dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2carboxylic Acid (L-Ampicillin) Imp. C (EP): (4S)-2-(3,6-Dioxo-5-phenylpiperazin-2-yl)5,5-dimethylthiazolidine-4-carboxylic Acid (Diketopiperazines of Ampicillin)

O O N H2N S H

OH

(B)

100 mg

MM 0253.02

O O NH2 H N N S H
O HN S O

OH

(A)

100 mg

MM 0253.03

OH

(A)

100 mg

H N N H

MM 0253.04

Imp. D (EP) as Sodium Salt: (4S)-2-[[[(2R)-2-Amino2-phenylacetyl]amino]carboxymethyl]5,5-dimethylthiazolidine-4-carboxylic Acid Sodium Salt (Penicilloic Acids of Ampicillin Sodium Salt) Imp. F (EP): (2RS,4S)-2-[[[(2R)-2-Amino2-phenylacetyl]amino]methyl]-5,5-dimethyl-thiazolidine4-carboxylic Acid (Penilloic Acids of Ampicillin)

O NH2 HN S O

ONa

(A)

100 mg

H N

O HO

MM 0253.06

O NH 2 HN S

OH

(A)

100 mg

H N

MM 0253.08

Imp. H (EP): 3-Phenylpyrazin-2-ol

HO

N N

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
O NH OH O

Unit

MM 0253.11

Imp. K (EP): (2R)-2-[(2,2-Dimethylpropanoyl)-amino]-2phenylacetic Acid

(A)

100 mg

MM 0253.12

Imp. L (EP): (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine) Ampicillin, anhydrous


O NH 2 H N N

NH 2 OH O

(B)

100 mg

MM 0253.16

OH

(A)

500 mg

S H

Androstanolone
MM 0565.00 Androstanolone
OH

(A)

250 mg

Anise Oil
MM 0164.01 MM 0164.02 MM 0164.03 MM 0164.05 trans-Anethole
O

(C) (C)
O

100 mg 100 mg 100 mg 100 mg

Estragole Anisaldehyde
O O

(C) (C)

Linalol
HO

MM 0164.06

cis-Anethole
O

(D)

100 mg

Antazoline Hydrochloride
MM 0171.00 Antazoline Hydrochloride
N N N H x HCl

(A)

500 mg

MM 0171.01

Imp. A (EP) as Dihydrochloride: N-(2-Aminoethyl)2-(benzylphenylamino)acetamide Dihydrochloride


N

(A)
O N H NH 2
N N H x HCl

100 mg

x 2 HCl

MM 0171.04

Imp. B (Pharmeuropa) as Hydrochloride: 2-(Chloromethyl)-4,5-dihydro-1H-imidazole Hydrochloride


Cl

(A)

100 mg

MM 0171.03

N-Benzylaniline

NH

(B)

100 mg

Antazoline Phosphate
MM 0561.00 Antazoline Phosphate
N N H N x H3PO4

(A)

500 mg

Apomorphine Hydrochloride Hemihydrate


MM 0562.00 Apomorphine Hydrochloride Hemihydrate
HO N OH x HCl x H2O

(A)
H

250 mg

MM 0037.00

Imp. B (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]


HO O

N x HCl x 3 H2O OH

(A)

250 mg

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33

Pharmaceutical impurities
Code Product Price Unit

Aprindine Hydrochloride
MM 0467.00 Aprindine Hydrochloride
N N HCl

on request

Arginine
MM 0568.00 Arginine
H2N H N NH NH2 OH O

(A)

500 mg

Arginine Hydrochloride
MM 0569.00 Arginine Hydrochloride
H2N H N NH NH2 OH O x HCl

(A)

500 mg

Aripiprazole
New MM 0961.00 Aripiprazole
Cl Cl N N

(A)

100 mg

N H

Articaine Hydrochloride
MM 0369.00 Articaine Hydrochloride
O S O H N O
O S O H N O

(A)
N H x HCl

100 mg

MM 0369.01

Imp. A (EP) as Hydrochloride: Methyl 3-[[2-(Propylamino)acetyl]amino]-4-methylthiophene2-carboxylate Hydrochloride (Acetamidoarticaine Hydrochloride) Imp. B (EP) as Hydrochloride: 4-Methyl-3-[[(2RS)2-(propylamino)propanoyl]amino]thiophene-2-carboxylic Acid Hydrochloride (Articaine Acid Hydrochloride) Imp. C (EP) as Hydrochloride: 1-Methylethyl 4-Methyl3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene2-carboxylate Hydrochloride (Articaine Isopropyl Ester Hydrochloride) Imp. D (EP) as Hydrochloride: Methyl 3-[[(2RS)2-(Ethylamino)propanoyl]amino]-4-methylthiophene2-carboxylate Hydrochloride (Ethylarticaine Hydrochloride) Imp. E (EP) as Hydrochloride: Methyl 4-Methyl-3-[[(2RS)2-[(1-methylethyl)amino]propanoyl]amino]thiophene2-carboxylate Hydrochloride (Isopropylarticaine Hydrochloride) Imp. F (EP) as Hydrochloride: 4-Methyl-N-propyl3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene2-carboxamide Hydrochloride (Articaine Acid Propionamide Hydrochloride) Imp. G (EP) as Hydrochloride: Methyl 3-[[(2RS)2-(Butylamino)propanoyl]amino]-4-methylthiophene2-carboxylate Hydrochloride (Butylarticaine Hydrochloride) Imp. H (EP) as Hydrochloride: Methyl 3-[[(2RS)2-(Dipropylamino)propanoyl]amino]-4-methylthiophene2-carboxylate Hydrochloride (Dipropylarticaine Hydrochloride) Imp. I (EP): Methyl 3-Amino-4-methylthiophene-2-carboxylate (3-Aminoarticaine) Imp. J (EP): Methyl 3-[[(2RS)-2-Bromopropanoyl]amino]4-methylthiophene-2-carboxylate (Bromo Compound)

(A)
N H x HCl

100 mg

MM 0369.02

HO S

H N O

(A)
N H x HCl

50 mg

MM 0369.03

O S

H N O

(A)
N H x HCl

100 mg

MM 0369.04

O S

H N O

(B)
N H x HCl

10 mg

MM 0369.05

O S

H N O

(A)
N H x HCl

100 mg

MM 0369.06

H N S

H N O

(A)
N H x HCl

50 mg

MM 0369.07

O S

H N O

(A)
N H x HCl

100 mg

MM 0369.08

O S

H N O

(A)
N x HCl

100 mg

MM 0369.09

O S

O NH2

(C)

100 mg

MM 0369.10

O S

H N O

(B)
Br

10 mg

34

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Pharmaceutical impurities
Code Product Price Unit

Ascorbic Acid
MM 0166.00 L-Ascorbic Acid
HO HO OH O O OH

(A)

500 mg

Asparagine Monohydrate
MM 0765.01 Phenylacetylasparagine
O H 2N O HN OH O

(C)

50 mg

Aspartame
MM 0314.00 Aspartame
HO O NH2 H N O O O

(A)

500 mg

MM 0314.01

Imp. A (EP): 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid (Diketopiperazine)


HO

O O HN NH O

(A)

100 mg

MM 0314.02

Imp. B (EP): L-Aspartyl-L-phenylalanine


HO

NH2 H N O

O OH

(A)

100 mg

MM 0314.03

Imp. C Aspartame (EP): Phenylalanine

O H2N OH

(B)

100 mg

Aspartic Acid
MM 0567.00 MM 0460.10 Aspartic Acid
HO O O NH2 OH

(A) (B)

500 mg 100 mg

Imp. B (Pharmeuropa): (E)-Butenedioic Acid (Fumaric Acid) Imp. D (Pharmeuropa): (S)-2-Aminopropanoic Acid (Alanine) Imp. F (Pharmeuropa): (2S)-2,5-Diamino-5oxopentanoic Acid (L-Glutamine)

O HO O OH
NH2 OH O

MM 0566.00

(A)

500 mg

MM 0169.00

NH2 H2N O O OH

(A)

500 mg

Astemizole
MM 0184.00 Astemizole
F N N HN N O

(A)

250 mg

MM 0184.13

Desmethyl Astemizole Hydrochloride

F N

HN N N OH x HCl

(B)

10 mg

Atenolol
MM 0013.00 Atenolol
O H2 N OH O H N

(A)

500 mg

MM 0013.03 MM 0013.05

Imp. A (EP): 2-(4-Hydroxyphenyl)acetamide


H2 N

OH

(B) (A)

100 mg 100 mg

Imp. B (EP): 2-[4-[(2RS)2,3-Dihydroxypropoxy)phenyl]acetamide


H2 N

OH O O OH

MM 0013.01

2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]acetamide
H2 N

(A)

100 mg

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35

Pharmaceutical impurities
Code Product Price
OH O H2 N O Cl

Unit

MM 0013.06

Imp. D (EP): 2-[4-[(2RS)-3-Chloro2-hydroxypropoxy]phenyl]acetamide Imp. E (EP): 2,2'-[(2-Hydroxypropane-1,3diyl)bis(oxy-4,1-phenylene)]diacetamide


H2 N

(A)

50 mg

MM 0013.07

OH O O O O NH2 OH O H2 N OH O HO O H N O N OH O O NH2

(A)

50 mg

MM 0013.02

Imp. F (EP): 2,2'-[[(1-Methylethyl)imino]bis[(2-hydroxypropane-3,1diyl)oxy-4,1-phenylene]]diacetamide

(A)

50 mg

MM 0013.04

Imp. G (EP): 2-[4-[(2RS)-2-Hydroxy3-[(1-methylethyl)amino]propoxy]phenyl]acetic Acid Imp. H (EP): 2-[4-[(2RS)-2-Hydroxy3-[(1-methylethyl)amino]propoxy]phenyl]acetonitrile Imp. I (EP): 2-[4-[(2RS)-3-(Ethylamino)-2hydroxypropoxy]phenyl]acetamide
H2N

(A)

50 mg

MM 0013.08

OH O N

H N

(A)

100 mg

MM 0013.17

OH O O

H N

(A)

50 mg

MM 0013.13

4-Hydroxyphenylacetic Acid
HO

OH

(B)

100 mg

Atorvastatin Calcium Trihydrate


MM 0400.00 Atorvastatin Calcium
O N H N OH O O OH -

(D)

100 mg

Ca2+

2
O N H O O F O

New MM 0400.11

Imp. D (EP): 3-[(4-Fluorophenyl)carbonyl]-2-(2methylpropanoyl)-N,3-diphenyloxirane-2-carboxamide Imp. G (Pharmeuropa) as Calcium Salt: (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4(phenylcarbamoyl)-5-(propan-2-yl)-1Hpyrrol-1-yl]-5-hydroxy-3-methoxyheptanoic Acid Calcium Salt (3-O-Methylatorvastatin Calcium Salt) Imp. G (Pharmeuropa) as Lithium Salt: (3R,5R)-7[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)5-(propan-2-yl)-1H-pyrrol-1-yl]-5-hydroxy-3-methoxyheptanoic Acid Lithium Salt (3-O-Methylatorvastatin Lithium Salt)

(D)

100 mg

MM 0400.12

O O N H N OH O O -

(D)

100 mg

Ca2+

2
O

MM 0400.16

(D)
OLi

100 mg

O N H N

OH O

MM 0400.01

Imp. H (Pharmeuropa): (2R,4R)-2-[2-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan2-yl)-1H-pyrrol-1-yl]ethyl]-4-hydroxytetrahydro-2Hpyran-6-one (Atorvastatin Lactone)

O O N H N O OH

(D)

100 mg

MM 0400.04

1,1-Dimethylethyl (4R-cis)6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)3-phenyl-4-[(phenylamino)carbonyl]-1-H-pyrrol1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetate

(A)
O N H N O O O O

100 mg

MM 0400.05

1,1-Dimethylethyl (4R-cis)-6-Aminoethyl-2,2-dimethyl1,3-dioxane-4-acetate
H2N

(A)
O O O O

100 mg

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Code Product Price
O O N H N O

Unit

MM 0400.13

1-[2-[(2S)-3,6-Dihydro-6-oxo-2H-pyran-2-yl]-ethyl]5-(4-fluorophenyl)-2-(1-methylethyl)-N,4-diphenyl-1Hpyrrole-3-carboxamide (Atorvastatin eliminated Lactone)

(A)

100 mg

Atracurium Besilate
MM 0858.13 Imp. J (EP): Methyl Benzenesulphonate
O O S O

(A)

100 mg

Atropine
MM 0289.18 Atropine
H O H O N

(A)

250 mg

H OH and enantiomer

MM 0289.00

Atropine Sulphate

H O H O OH H N 2
H O H O H N x HCl

(A)
x H2SO4 x H2O and enantiomer

500 mg

MM 0289.01

Imp. A (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl8-azabicyclo[3.2.1]oct-3-yl 2-Phenylpropenoate Hydrochloride (Apoatropine Hydrochloride) Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid) Imp. F (EP) as Hydrobromide Trihydrate: Hyoscine Hydrobromide Trihydrate

(D)

100 mg

MM 0601.03

O OH OH

(A)

100 mg

MM 0546.00

H O H O OH N H

H O H
O OH

(A)
x HBr x 3 H2O

500 mg

MM 0289.03

Atropic Acid

(A)

100 mg

Avobenzone
MM 0902.00 Avobenzone
O O

(A)
O

500 mg

Azelaic Acid
MM 0687.00 Azelaic Acid
HO O O OH

(A)

500 mg

Azelastine Hydrochloride
MM 0362.00 Azelastine Hydrochloride
O N N x HCl N

(A)

100 mg

Cl

MM 0362.04

Imp. A (EP): Benzoyldiazane (Benzohydrazide) Imp. B (EP) as Dihydrochloride: 1-Benzoyl2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl] diazane Dihydrochloride

O NH NH2

(C)

100 mg

MM 0362.07

H N O

N N H

(A)
x 2 HCl

100 mg

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Pharmaceutical impurities
Code Product Price
O OH O

Unit

MM 0362.05

Imp. C (EP): 2-[(4-Chlorophenyl)acetyl]benzoic Acid

(A)

100 mg

Cl

MM 0362.01

Imp. D (EP): 4-(4-Chlorobenzyl)phthalazin-1(2H)-one

O NH N

(A)

100 mg

Cl

MM 0362.06

Imp. E (EP) Z-Isomer: (Z)-3-(4-Chlorobenzylidene)isobenzofuran-1(3H)-one

O O

(A)

100 mg

Cl

MM 0362.03

1-Methylazepan-4-one Hydrochloride
O

x HCl

(A)

100 mg

Azithromycin
MM 1075.00 Azithromycin
HO O O N OH OH O OO N OH HO O O

(A)

100 mg

MM 1075.01

Imp. A (EP): 6-Demethylazithromycin (Azaerythromycin A)


HO OO OH N OH OO O

H N OH HO O O

(D)

100 mg

Baclofen
MM 1235.03 Imp. B (EP): (3RS)-5-Amino-3-(4-chlorophenyl)5-oxopentanoic Acid
Cl O H2N O OH

(A)

100 mg

MM 1235.01

3-(4-Chlorophenyl)glutaric Acid
HO

O O OH Cl

(A)

100 mg

Bambuterol Hydrochloride
MM 0773.04 Imp. D (EP): 5-[(1RS)-1-Hydroxyethyl]-1,3-phenylene Bis(dimethylcarbamate)
OH N O N O O O

(A)

100 mg

MM 0773.05

Imp. E (EP): 5-Acetyl-1,3-phenylene Bis-(dimethylcarbamate)

O N O N O O O

(A)

100 mg

Basic Butylated Methacrylate Copolymer


MM 0753.01 MM 0753.02 Imp. A (EP): Butyl Methacrylate Imp. B (EP): Methyl Methacrylate
O O

(A)
O O

100 mg 100 mg

(A)

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Pharmaceutical impurities
Code Product Price
O O N

Unit

MM 0753.03

Imp. C (EP): 2-(Dimethylamino)ethyl Methacrylate

(A)

100 mg

Beclometasone Dipropionate
MM 0199.00 Beclometasone Dipropionate
O O HO Cl O O O O

(A)

250 mg

MM 0199.02

Imp. A (EP): 9-Chloro-11,17-dihydroxy-16methyl-3,20-dioxopregna-1,4-dien-21-yl Propanoate (Beclometasone 21-Propionate)


O

O O HO O OH

(A)

100 mg

Cl

MM 0199.06

Imp. B (EP): 21-(Acetyloxy)-9-chloro-11hydroxy-16-methyl-3,20-dioxopregna-1,4dien-17-yl Propanoate (Beclometasone 21-Acetate 17-Propionate)


O

O O HO O O O

(A)

100 mg

Cl

MM 0199.05

Imp. C (EP): 9-Chloro-11-hydroxy-16-methyl3,20-dioxo-17-(propanoyloxy)-pregna-1,4-dien21-yl Butanoate (Beclometasone 21-Butyrate 17-Propionate)


O

O O HO O O O

(A)

100 mg

Cl

MM 0199.01

Imp. H (EP): 9-Chloro-11,21-dihydroxy-16methyl-3,20-dioxopregna-1,4-dien-17-yl Propanoate (Beclometasone 17-Propionate)


O

O HO O

OH O

(A)

100 mg

Cl

MM 0199.03

9-Chloro-11,17,21-trihydroxy-16-methylpregna1,4-diene-3,20-dione (Beclometasone)

O HO

OH OH

(A)

100 mg

Cl O

Benazepril Hydrochloride
MM 1229.00 Benazepril Hydrochloride
O H N O O N O OH x HCl

(A)

100 mg

Bendroflumethiazide
MM 0674.01 Imp. A (EP): 4-Amino-6-(trifluoromethyl)benzene1,3-disulphonamide
O O H2N S F F F O S O NH2

(A)

100 mg

NH2

Benfluorex Hydrochloride
New MM 1298.01 Imp. A (EP) as Hydrochloride: 2-[[(1RS)1-Methyl-2-[2-(trifluoromethyl)phenyl] ethyl]amino]ethyl Benzoate Hydrochloride Imp. B (EP) as Hydrochloride: 2-[[(1RS)-1Methyl-2-[4-(trifluoromethyl)phenyl]ethyl]amino]ethyl Benzoate Hydrochloride Imp. C (EP): Benzoic Acid
HO

H N F F F

O O x HCl

(A)

50 mg

New MM 1298.02

H N F F F

O O x HCl

(A)

50 mg

MM 0278.01

(B)

100 mg

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39

Pharmaceutical impurities
Code Product Price Unit

New MM 1298.05

Imp. E (EP): N-(2-Hydroxyethyl)-N-[(1RS)-1-methyl2-[3-(trifluoromethyl)phenyl]ethyl]benzamide

(A)
O N OH

50 mg

F F

New MM1298.06

Imp. F (EP): 2-[Benzoyl[(1RS)-1-methyl-2-[3-(trifluoromethyl)phenyl]ethyl]amino]ethyl Benzoate

(A)
O N O O

50 mg

F F

Benperidol
MM 0113.00 Benperidol
O N F O NH N

(A)

100 mg

MM 0113.03

Imp. A (EP): 1-(Piperidin-4-yl)-1,3-dihydro-2Hbenzimidazol-2-one


HN

O NH N

(A)

100 mg

MM 0113.07

4-Chloro-4'-fluorobutyrophenone
F

O Cl

(B)

100 mg

Benzalkonium Chloride
MM 0224.00 MM 0795.00 MM 0224.01 MM 0224.02 MM 0224.03 Benzalkonium Chloride
N
n

Cl

(A) (A)
OH

500 mg 500 mg 500 mg 500 mg 500 mg

Imp. A (EP): Benzyl Alcohol Benzyldimethyldodecylammonium Chloride


N
5

Cl

(A) (A)
6

Benzyldimethyltetradecylammonium Chloride
N

Cl

Benzyldimethylhexadecylammonium Chloride
N

Cl
7

(A)

Benzbromarone
MM 0456.00 Benzbromarone
O OH Br O Br

(A)

500 mg

Benzocaine
MM 0094.00 Benzocaine
H2N O O

(A)

500 mg

MM 0094.01

Benzocaine Acetylsalicylamide
O N H O O

O O

(C)

50 mg

MM 0094.02

N-Acetylbenzocaine
O N H

O O

(A)

100 mg

MM 0094.03

4-Aminobenzoic Acid
H2N

O OH

(B)

100 mg

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Pharmaceutical impurities
Code Product Price
O O O 2N

Unit

MM 0094.04

Ethyl 4-Nitrobenzoate

(B)

100 mg

Benzydamine Hydrochloride
MM 0142.00 Benzydamine Hydrochloride
N N O N x HCl

(A)

500 mg

MM 0142.04

Imp. C (BP): 1-Benzyl-1H-indazol-3-ol


N N OH

(A)

100 mg

MM 0142.08

Benzydamine N-Oxide Hydrochloride


N N O N O
x HCl

(A)
x HCl

100 mg

MM 0290.02

1-Chloropropyl(dimethyl)amine Hydrochloride (N,N-Dimethyl-3-chloropropylamine Hydrochloride)

Cl

(B)

100 mg

Benzyl Alcohol
MM 0795.00 MM 0795.02 Benzyl Alcohol
OH

(A)
OH

500 mg 100 mg

Imp. B (EP): Cyclohexylmethanol

(A)

Benzyl Benzoate
MM 0570.00 Benzyl Benzoate
O O

(A)

500 mg

Benzyl Nicotinate
MM 0104.00 Benzyl Nicotinate
N O O

(A)

500 mg

MM 0553.00

Nicotinic Acid
N

O OH

(A)

500 mg

Benzylpenicillin Benzathine
MM 0513.00 Benzylpenicillin Benzathine
O H N x N H O O H N N S H 2
HN NH2

OH

(A)

500 mg

MM 0513.02

Imp. A (EP): Monobenzylethylendiamine

(C)

100 mg

MM 0160.03 MM 0160.07

Imp. B (EP): Phenylacetic Acid [Drug Precursor]


O

OH

(B) (A)

100 mg 100 mg

Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7atetrahydroimidazo[5,1-b]-thiazole-3,7-dicarboxylic Acid (Penillic Acid of Benzylpenicillin)


HO

O N O O H N O O HN S OH O H N O HN S N H S

OH

MM 0160.01

Imp. E (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]5,5-dimethylthiazolidine-4-carboxylic Acid (Penicilloic Acids of Benzylpenicillin) Imp. F (EP): (2RS,4S)-2-[[(Phenylacetyl)amino]methyl]5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Benzylpenicillin)

OH

(A)

100 mg

MM 0160.05

OH

(A)

100 mg

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41

Pharmaceutical impurities
Code Product Price
H N x N H HO 2

Unit

MM 0513.01

N,N-Dibenzylethylenediamine Diacetate

(C)
O

100 mg

Benzylpenicillin Potassium
MM 0160.00 Benzylpenicillin Potassium
O O N H N H S O O H2 N N H S O OK

(A)

250 mg

MM 0026.04

Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) Imp. B (EP): Phenylacetic Acid [Drug Precursor] Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7atetrahydroimidazo[5,1-b]-thiazole-3,7-dicarboxylic Acid (Penillic Acid of Benzylpenicillin)

OH

(B)

100 mg

MM 0160.03 MM 0160.07

O OH O N HO O O H N O O HN S OH O H N O HN S OH OH N H S OH

(B) (A)

100 mg 100 mg

MM 0160.01

Imp. E (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]5,5-dimethyl-thiazolidine-4-carboxylic Acid (Penicilloic Acids of Benzylpenicillin) Imp. F (EP): (2RS,4S)-2-[[(Phenylacetyl)amino]methyl]5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Benzylpenicillin)

(A)

100 mg

MM 0160.05

(A)

100 mg

Benzylpenicillin Procaine
MM 0094.03 Imp. A (EP): 4-Aminobenzoic Acid
H2N O OH

(B)

100 mg

MM 0160.01

Imp. B (EP): (4S)-2-[Carboxy[(phenyl-acetyl)amino]methyl]5,5-dimethyl-thiazolidine-4-carboxylic Acid (Penicilloic Acids of Benzylpenicillin)


O

O HN S OH
O HN S

OH

(A)

100 mg

H N O

MM 0160.05

Imp. C (EP): (2RS,4S)-2-[[(Phenylacetyl)-amino]methyl]5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Benzylpenicillin)


O

OH

(A)

100 mg

H N

MM 0160.07

Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7atetrahydroimidazo[5,1-b]thiazole-3,7-dicarboxylic Acid (Penillic Acid of Benzylpenicillin)


HO

O N S H O

OH

(A)

100 mg

MM 0160.03

Imp. E (EP): Phenylacetic Acid [Drug Precursor]


O

OH

(B)

100 mg

Betahistine Dihydrochloride
MM 0587.00 Betahistine Dihydrochloride
N H N

(A)
x 2 HCl

500 mg

MM 0587.01 MM 0587.02 MM 0587.03

Imp. A (EP): 2-Ethenylpyridine (2-Vinylpyridine) Imp. B (EP): 2-(Pyridin-2-yl)ethanol (2-(2-Hydroxyethyl)pyridine) Imp. C (EP) as Trihydrochloride: N-Methyl-2-(pyridin2-yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine Trihydrochloride Imp. C (EP) as Trimesilate: N-Methyl-2-(pyridin-2-yl)N-[2-(pyridin-2-yl)ethyl]ethanamine Trimesilate
N N

(C)
OH

100 mg 100 mg 100 mg

(B) (A)

x 3 HCl

MM 0587.04

x3

O OH

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Betaine Hydrochloride
MM 0611.00 Betaine Hydrochloride
O N OH Cl

(A)

500 mg

Betamethasone
MM 0200.00 Betamethasone
HO O OH OH

(A)

250 mg

F O

MM 0213.00

Imp. A (EP): Dexamethasone


HO

O OH OH

(A)

250 mg

F O

MM 0200.01

Imp. B (EP): 21-Chloro-9-fluoro-11,17-dihydroxy-16methylpregna-1,4-diene-3,20-dione (Clobetasol)

O HO OH Cl

(A)

100 mg

F O

Betamethasone Acetate
MM 0201.00 Betamethasone Acetate
HO F O O O O OH

(A)

250 mg

MM 0200.00

Imp. A (EP): Betamethasone


HO F O

OH OH

(A)

250 mg

MM 0445.00

Imp. B (EP): Dexamethasone Acetate


HO F O

O O O OH

(A)

250 mg

MM 0201.03

Imp. C (EP): Betamethasone 11,21-Diacetate

O O

O OH O

(A)

100 mg

F O

Betamethasone Dipropionate
MM 0200.00 Imp. A (Pharmeuropa): 9-Fluoro-11,17,21trihydroxy-16-methylpregna-1,4-diene-3,20dione (Betamethasone)
O O HO OH OH

(A)

250 mg

MM 0202.00

Betamethasone Dipropionate
O O HO F O O

O O

(A)

250 mg

MM 0202.04

Imp. C (Pharmeuropa): 9-Fluoro-11,17-dihydroxy16-methyl-3,20-dioxopregna-1,4-dien-21-yl Propanoate (Betamethasone 21-Propionate)

O O HO O OH

(A)

100 mg

F O

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43

Pharmaceutical impurities
Code Product Price
O O HO O O O

Unit

MM 0199.00

Imp. E (Pharmeuropa): 9-Chloro-11-hydroxy16-methyl-3,20-dioxopregna-1,4-diene-17,21diyl Dipropanoate (Beclometasone Dipropionate)

(A)

250 mg

Cl O

Betamethasone Sodium Phosphate


MM 0303.00 Betamethasone Sodium Phosphate
O HO F O O O P ONa ONa OH

(A)

250 mg

Betamethasone 17-Valerate
MM 0203.00 Betamethasone 17-Valerate
HO F O O OH O O

(A)

250 mg

MM 0200.00

Imp. A (EP): Betamethasone


HO

OH OH

(A)

250 mg

F O

Betaxolol Hydrochloride
MM 0436.01 Imp. A (EP) as Hydrochloride: (2RS)1-(4-Ethylphenoxy)-3-[(1-methylethyl)amino]propan-2-ol Hydrochloride Imp. B (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]3-[(1-methylethyl)amino]propan-2-ol
HO
OH O H N

(A)
x HCl

50 mg

MM 0027.10

OH O

H N

(A)

100 mg

MM 0436.03

Imp. C (EP): 2-[[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane


O

(A)

50 mg

MM 0436.04

Imp. D (EP): 4-[2-(Cyclopropylmethoxy)ethyl]phenol


O

OH

(A)

50 mg

MM 0436.05

Imp. E (EP) as Hydrochloride: (2RS)1-[4-(2-Butoxyethyl)phenoxy]3-[(1-methylethyl)amino]propan-2-ol Hydrochloride 1-[4-(2-Cyclobutoxyethyl)phenoxy]3-(isopropylamino)propan-2-ol Hydrochloride

OH O O x HCl

H N

(A)

50 mg

MM 0436.06

OH O O

H N

(D)

50 mg

x HCl

Bezafibrate
MM 0063.00 Bezafibrate
O N H Cl O O OH

(A)

500 mg

MM 0063.01

Imp. A (EP): 4-Chloro-N-[2-(4-hydroxyphenyl)ethyl] benzamide (4-Chlorobenzoyltyramine)


Cl

O N H

OH

(A)

100 mg

MM 0063.03

Imp. B (EP): 4-Chlorobenzoic Acid


Cl

O OH

(B)

100 mg

MM 0063.04

Imp. C (EP): Methyl2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]2-methylpropanoate


Cl

O O N H O O

(A)

100 mg

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Code Product Price
O O N H Cl O O

Unit

MM 0063.02

Imp. D (EP): Ethyl 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2-methylpropanoate

(A)

100 mg

MM 0063.05

Imp. E (EP): Butyl 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2-methylpropanoate


Cl

O O N H O O

(A)

100 mg

MM 0063.06 MM 0063.07

Tyramine
H2 N

OH

(B) (A)

100 mg 100 mg

N,O-Bis-(4-chlorobenzoyl)tyramine
O N H Cl O O

Cl

Bicalutamide
MM 0894.00 Bicalutamide
F S O O N O N H
H N O N

(A)

100 mg

F F
F

OH

F
F F

MM 0894.01

N-[4-Cyano-3-(trifluoromethyl)phenyl]3-[(4-fluorophenyl)sulfinyl]-2-hydroxy2-methylpropanamide

O HO S F

(A)

50 mg

Bifonazole
MM 0318.00 Bifonazole
N N

(A)

500 mg

MM 0318.01

Imp. A (EP): (RS)-(Biphenyl-4-yl)phenylmethanol


OH

(A)

100 mg

MM 0015.02 MM 0318.03

Imp. C (EP): 1H-Imidazole (Imidazole) Imp. D (EP) as Chloride: 1,3-Bis[(biphenyl-4-yl)phenylmethyl]-1H-imidazolium Chloride


N+ N

H N N

(B) (D)

100 mg 100 mg

Cl-

Bisacodyl
MM 0031.00 Bisacodyl
O N O O O

(A)

500 mg

MM 0031.01

Imp. A (EP): 4,4'-(Pyridin-2-ylmethylene)diphenol

HO

OH

(A)

100 mg

MM 0031.04

Imp. B (EP): 2-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl) methyl]phenol


N

OH

OH

(A)

50 mg

MM 0031.02

Imp. C (EP): 4-[(RS)-(4-Hydroxyphenyl)(pyridin2-yl)methyl]phenyl Acetate

HO

O O N

(A)

100 mg

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45

Pharmaceutical impurities
Code Product Price
O O O O N

Unit

MM 0031.03

Imp. E (EP): 2-[(RS)-[4-(Acetyloxy)phenyl](pyridin2-yl)methyl]phenyl Acetate

(A)

50 mg

MM 0054.01

4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)-methyl]phenyl Sodium Sulphate (4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]phenyl Sodium Sulphate) 2-[(RS)-(Pyridin-2-yl)[4-(sulphonatooxy)phenyl]methyl]phenyl Disodium Sulphate (2,4'-[(Pyridin-2-yl)methylene]bisphenyl Bis (Sodium Sulphate))

HO

ONa S O O

(A)

100 mg

MM 0054.02

NaO O

O O O O ONa O

(D)

50 mg

Bisoprolol Fumarate
MM 0460.00 Bisoprolol
O O OH O H N

(A)

100 mg

MM 0460.08

Bisoprolol Fumarate
O

OH

H N x

OH O

(A)

100 mg

O O 2
OH O

HO
H N

MM 0460.01

Imp. A (EP): (RS)-1-(4-Hydroxymethylphenoxy)-3-isopropylaminopropan-2-ol


OH

(A)

100 mg

MM 0460.07

Imp. B (EP): (RS)-1-Isopropylamino-3-[4-(2propoxyethoxymethyl)phenoxy]propan-2-ol


O O

OH O

H N

(A)

100 mg

MM 0460.15

Imp. C (EP): (RS)-1-[4-[4-(2-Hydroxy3-isopropylaminopropoxy)benzyl]phenoxy]-3-isopropylaminopropan-2-ol Imp. G (EP): (2RS)-1-[4-[[(2-Isopropoxyethoxy)methoxy]methyl]phenoxy]-3-isopropylaminopropan-2-ol

H N

OH O O

OH

H N

(A)

100 mg

MM 0460.21

OH O

H N

(D)

100 mg

O
OH O OH

MM 0460.24

Imp. J (Pharmeuropa): (2RS)-3-[4-((2-Isopropoxyethoxy)methyl)phenoxy]-1,2-propanediol Imp. K (EP): 2-Isopropoxyethyl 4-[[(2RS)2-Hydroxy-3-(isopropylamino)propyl]oxy]benzoate (Bisoprolol Ester) Imp. L (EP) as Hydrochloride: 4-[[(2RS)-2-Hydroxy3-(isopropylamino)propyl]oxy]benzaldehyde Hydrochloride (4-[(2RS)-2-Hydroxy-3-[(1-methylethyl)amino]propoxy]benzaldehyde Hydrochloride) Imp. M (Pharmeuropa): 4-[(2-Isopropoxyethoxy) methyl]phenol Imp. N (EP): [(2RS)-1-[4-[(2-Ethoxyethoxy)methyl]phenoxy]-3-isopropylaminopropan-2-ol Imp. Q (EP): (2RS)-1-(Isopropylamino)-3-[4-(2methoxyethoxy)methyl]phenoxypropan-2-ol Imp. R (EP): (2RS)-1-(Isopropylamino)-3-(4methylphenoxy)propan-2-ol

(A)

100 mg

O O

MM 0460.18

OH O O O O

H N

(A)

100 mg

MM 0027.24

OH O

H N x HCl

(A)

100 mg

MM 0460.02

O O

OH

(A)

100 mg

MM 0460.25

OH O O O

H N

(A)

100 mg

MM 0460.05

OH O O O

H N

(A)

100 mg

MM 0460.28

OH O

H N

(A)

50 mg

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Pharmaceutical impurities
Code Product Price
OH O

Unit

MM 0460.14 MM 0460.17

Imp. S (EP): 4-Hydroxybenzaldehyde Imp. T (EP): 4-[(3-Isopropyl-2-oxo-1,3-oxazolidin-5yl)methoxy]benzaldehyde (Bisoprolol Oxazolidinonebenzaldehyde)


O O O O N

(C) (A)

100 mg 50 mg

MM 0460.16

Imp. U (EP): 5-[[4-(Hydroxymethyl)phenoxy]methyl]-3-isopropyl-1,3-oxazolidin-2-one (Bisoprolol Oxazolidinonebenzylalcohol)


HO

O O O N

(A)

50 mg

MM 0460.27

(2RS)-4-[2-Hydroxy-3-(isopropylamino)propoxy]benzoic Acid Hydrochloride


HO O

OH O

H N x HCl

(A)

50 mg

MM 0460.03 MM 0460.06 MM 0460.10 MM 0460.23

2-[4-(2-Isopropoxyethoxymethyl)phenoxymethyl]oxirane
O O

(A) (B) (B)

100 mg 100 mg 100 mg 50 mg

4-Hydroxybenzyl Alcohol
HO

OH

Fumaric Acid (2RS)-1-[4-((2-Hydroxyethoxy)methyl)phenoxy]3-(isopropylamino)-2-propanol

O HO O OH

OH HO O O

H N

(A)

Boldenone
MM 0864.00 Boldenone
OH

(A)

100 mg

Brimonidine Tartrate
MM 1324.00 Brimonidine Tartrate
N H N N H N N Br x HO O OH OH O OH

(A)

100 mg

Bromazepam
MM 0064.00 Bromazepam [Controlled Substance]
Br N H N N O

(A)

100 mg

MM 0064.01

Imp. A (EP): (2-Amino-5-bromophenyl)(pyridin-2-yl)methanone


Br

NH2 O N

(A)

100 mg

MM 0064.02

Imp. B (EP): N-[4-Bromo-2-(pyridin-2ylcarbonyl)phenyl]-2-chloroacetamide


Br

O NH O N

Cl

(A)

50 mg

MM 0064.09

Imp. C (EP): 7-Bromo-5-(6-methylpyridin-2-yl)-1,3-dihydro-2H1,4-benzodiazepin-2-one


Br N

H N N

(A)

50 mg

MM 0064.04

Imp. D (EP): 3-Amino-6-bromo-4-(pyridin2-yl)quinolin-2(1H)-one


Br N

H N

O NH2

(A)

50 mg

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Pharmaceutical impurities
Code Product Price
O NH Br N O Br

Unit

MM 0064.07

Imp. E (EP): 2-Bromo-N-[4-bromo-2-(pyridin2-ylcarbonyl)phenyl]acetamide

(A)

50 mg

Bromhexine Hydrochloride
MM 0065.00 Bromhexine Hydrochloride
Br NH 2 Br

(A)
N x HCl

500 mg

MM 0005.01

Imp. A (EP): (2-Amino-3,5-dibromophenyl)methanol

Br

OH NH2 Br

(A)

100 mg

MM 0005.02

Imp. B (EP): 2-Amino-3,5-dibromobenzaldehyde

Br

O NH2 Br

(A)

100 mg

MM 0065.02

Imp. C (EP): N-(2-Aminobenzyl)-N-methylcyclohexanamine


N NH 2

(A)

100 mg

MM 0065.03

Imp. D (EP) as Dihydrochloride: N-(2-Amino-5-bromobenzyl)-Nmethylcyclohexanamine Dihydrochloride

Br N NH2 x 2 HCl

(A)

100 mg

MM 0065.01

N-(2-Nitrobenzyl)-N-cyclohexyl-N-methylamine
N NO2

(A)

100 mg

MM 0065.05

6,8-Dibromo-3-cyclohexyl-3,4-dihydro-2(1H)-quinazolinone
Br

Br

(A)

100 mg

HN O

MM 0065.09

Bromhexine N-Oxide
Br

Br

(A)
N

100 mg

NH2

Bromisoval
MM 1128.01 Ethyl 2-Bromoisovalerate
Br O O

(A)

100 mg

Brompheniramine Maleate
MM 0060.00 Brompheniramine Maleate
N x N Br O O OH OH

(A)

500 mg

MM 0090.00

Imp. A (EP) as Maleate: Chlorphenamine Maleate


N x N Cl

O OH OH O O N x N Cl O OH OH

(A)

500 mg

MM 1114.00

Imp. B (EP) as Maleate: Dexchlorpheniramine Maleate

(A)

100 mg

MM 0059.01

Imp. C (EP): (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-2-yl)propan-1-amine (Pheniramine)

(A)
N N

100 mg

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Pharmaceutical impurities
Code Product Price
O N x N O OH OH

Unit

MM 0059.00

Imp. C (EP) as Maleate: (3RS)-N,N-Dimethyl3-phenyl-3-(pyridin-2-yl)propan-1-amine Maleate (Pheniramine Maleate) Brompheniramine N-Oxide

(A)

100 mg

MM 0060.12

on request
N N Br

MM 0060.16

Desmethylbrompheniramine Maleate
N x N H Br

O OH OH O

(A)

100 mg

Buclizine Hydrochloride
MM 0380.04 Imp. A (BP): 1,4-Bis(4-chlorobenzhydryl)piperazine (1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine)
Cl N N Cl

(A)

100 mg

MM 0380.09

4-Chlorobenzhydrol

Cl OH

(B)

100 mg

MM 0380.10

4-Chlorobenzophenone

Cl O

(B)

100 mg

MM 0380.01

1-(4-Chlorobenzhydryl)piperazine((RS)1-[(4-Chlorophenyl)phenylmethyl]piperazine)

Cl N

NH

(A)

100 mg

Budesonide
MM 0204.01 Imp. A (EP): 11,16,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione (16-Hydroxy-prednisolone)
O O HO OH OH OH

(A)

100 mg

MM 0204.02

Imp. B (EP): 16,17-[(1RS)-Ethylidenebis(oxy)]11,21-dihydroxypregna-1,4-diene-3,20-dione

O HO O

OH

(A)

50 mg

New MM 0204.07

Imp. G (EP): 16,17-[(1RS)-Butylidenebis(oxy)]11,21-dihydroxypregn-4-ene-3,20-dione (1,2-Dihydrobudesonide)


O

O HO O

OH

(A)

50 mg

New MM 0204.12

Imp. H (EP): 16,17-[(1RS)-Butylidenebis(oxy)]21-hydroxypregna-1,4,9(11)-triene-3,20-dione

O O

OH

(A)

50 mg

New MM 0204.13

Imp. I (EP): 11,17,21-Trihydroxy-3,20-dioxopregna1,4-dien-16-yl Butanoate

O HO

OH OH O O

(A)

50 mg

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49

Pharmaceutical impurities
Code Product Price
O HO O O Br O OH

Unit

New MM 0204.14

Imp. J (EP): 16,17-[(1RS)-Butylidenebis(oxy)]-9bromo-11,21-dihydroxypregna-1,4-diene-3,20-dione

(A)

50 mg

Bufexamac
MM 0179.00 MM 0179.01 MM 0179.02 MM 0179.03 MM 0179.04 MM 0179.05 Bufexamac
O O H N OH

(A) (A) (A) (A)

500 mg 100 mg 100 mg 100 mg 100 mg 100 mg

Imp. A (EP): 2-(4-Butoxyphenyl)acetic Acid


O O

OH

Imp. B (EP): Methyl 2-(4-Butoxyphenyl)acetate


O O O O O

Imp. C (EP): Butyl 2-(4-Butoxyphenyl)acetate Imp. D (EP): 2-(4-Butoxyphenyl)acetamide


O

NH2 O O

(A) (A)

4'-Butoxyacetophenone
O

MM 0179.06

Ethyl 2-(4-Butoxyphenyl)acetate
O O

on request

Buflomedil Hydrochloride
MM 0066.00 Buflomedil Hydrochloride
O O O N x HCl O OH O N O O O O N HO O
N

(A)

500 mg

MM 0066.01

Imp. A (EP) as Hydrochloride: 4-(Pyrrolidin-1-yl)-1(2-hydroxy-4,6-dimethoxyphenyl)butan-1-one Hydrochloride (o-Desmethyl-Buflomedil Hydrochloride) Imp. B (EP) as Hydrochloride: 4-(Pyrrolidin-1-yl)1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one Hydrochloride (p-Desmethyl-Buflomedil Hydrochloride) 4-(1-Pyrrolidino)butyronitrile 1,3,5-Trimethoxybenzene

(A)
x HCl

100 mg

MM 0066.02

(A)
x HCl

100 mg

MM 0066.03 MM 0066.05

N O

(C) (C)
O

100 mg 100 mg

Bunolol Hydrochloride
MM 0642.00 Bunolol Hydrochloride
O O OH H N

(A)
x HCl

100 mg

Buphenine Hydrochloride
MM 0710.00 Buphenine Hydrochloride
HO OH x HCl

(A)

500 mg

HN

Bupivacaine Hydrochloride
MM 0613.00 Bupivacaine Hydrochloride Monohydrate
H N O N x HCl x H2O

(A)

500 mg

MM 0368.03

Imp. A (EP): N-(2,6-Dimethylphenyl)pyridine2-carboxamide Imp. E (EP) as Hydrochloride: 6-(Butylamino)-N(2,6-dimethylphenyl)hexanamide Hydrochloride Imp. F (EP): 2,6-Dimethylaniline
H N O

H N O

(A)
N

100 mg

MM 0613.05

(A)
N H x HCl

50 mg

MM 0102.02

NH2

(B)

100 mg

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Pharmaceutical impurities
Code Product Price
H N O

Unit

MM 0613.07

Bupivacaine N-Oxide

(A)
N O

100 mg

Buprenorphine
New MM 0120.00 Buprenorphine [Controlled Substance]
N OH

(A)

100 mg

HO

H O

Bupropion Hydrochloride
MM 0745.00 Bupropion Hydrochloride
O Cl H N

(A)
x HCl

100 mg

MM 0745.02

2-(tert-Butylamino)-4'-chloropropiophenone Hydrochloride
Cl

H N

(A)
x HCl

100 mg

MM 0745.03

2-(tert-Butylamino)-3'-bromopropiophenone Hydrochloride

O Br

H N

(A)
x HCl

100 mg

MM 0745.05

2-(tert-Butylamino)propiophenone Hydrochloride

H N

(A)
x HCl

100 mg

MM 0745.07

1-(3-Chlorophenyl)-1-hydroxy-2-propanone

OH Cl O

(D)

100 mg

MM 0745.08

3-Chloropropiophenone

O Cl

(B)

100 mg

New MM 0745.14

Hydroxybupropion (as (RS,RS)-cyclic Hemiketal)


Cl HO

O NH

(A)

100 mg

and Enantiomer

Buspirone Hydrochloride
MM 0464.00 Buspirone Hydrochloride
O N O N N N N x HCl

(A)

500 mg

MM 0464.02

Imp. A (EP) as Dihydrochloride: 2-(Piperazin1-yl)pyrimidine Dihydrochloride Imp. C (EP): 2,2'-[Butane1,4-diylbis(piperazine1,4-diyl)]dipyrimidine


N N N N

HN N N N x 2 HCl

(A)

100 mg

MM 0464.04

(A)
N N N N

50 mg

New MM 0464.19

Imp. E (EP) as Hydrochloride: [1-[2-Oxo-2-[[4-[4(pyrimidin-2-yl)piperazin-1-yl]butyl]amino]ethyl]cyclopentyl]acetic Acid Hydrochloride

O O OH x HCl HN N N N N

(A)

50 mg

New MM 0464.20

Imp. F (EP) as Dioxalate: 4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butyl [1-[2-Oxo-2-[[4-[4-(pyrimidin2-yl)piperazin-1-yl]butyl]amino]ethyl]cyclopentyl]acetate Dioxalate

O O O O x2 O OH OH
N N N N N N

(A)
N N N N N N N N

50 mg

HN

MM 0464.12

Imp. G (EP): 2,2'-(Piperazine-1,4-diyl)dipyrimidine

(A)

50 mg

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51

Pharmaceutical impurities
Code Product Price Unit

Butalbital
MM 0899.00 5,5-Diallybarbituric acid (Allobarbital) [Controlled Substance]
O H N O NH O

(A)

100 mg

Butetamate Citrate
MM 0606.00 Butetamate Citrate
x O O O N O OH OH O OH OH

(A)

500 mg

Butorphanol Tartrate
New MM 1192.00 Butorphanol Tartrate
N HO x HO O HO OH OH O OH

(A)

100 mg

Butyl Parahydroxybenzoate
MM 0496.00 Butyl Parahydroxybenzoate
HO O O

(A)

500 mg

MM 0045.01

Imp. A (EP): 4-Hydroxybenzoic Acid


HO

O OH

(B)

100 mg

MM 0431.00

Imp. B (EP): Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0498.00

Imp. C (EP): Ethyl 4-Hydroxybenzoate (Ethyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0432.00

Imp. D (EP): Propyl 4-Hydroxybenzoate (Propyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0496.05

Imp. E (Pharmeuropa): 2-Methylpropyl 4Hydroxybenzoate (Isobutyl Parahydroxybenzoate)


HO

O O

(A)

100 mg

Butylhydroxytoluene
MM 0679.00 Butylhydroxytoluene
OH

(A)

500 mg

Caffeine
MM 0494.00 Caffeine
N O N O N N

(A)

500 mg

MM 0176.00

Imp. A (EP): Theophylline


N O

H N N

(A)

500 mg

MM 0176.02

Imp. B (EP): N-(6-Amino-1,3-dimethyl-2,4-dioxo1,2,3,4-tetrahydropyrimidin-5-yl)formamide


O

O N N

H N NH2 O

(A)

100 mg

MM 0494.03

Imp. C (EP): 1,3,9-Trimethyl-3,9-dihydro1H-purine-2,6-dione (Isocaffeine)


O

(A)
N N

50 mg

N N

52

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Pharmaceutical impurities
Code Product Price Unit

Butylhydroxytoluene
MM 0679.00 Butylhydroxytoluene
OH

(A)

500 mg

Caffeine
MM 0494.00 Caffeine
N O N
O N O N

O N N

(A)

500 mg

MM 0176.00

Imp. A (EP): Theophylline

H N N

(A)

500 mg

MM 0176.02

Imp. B (EP): N-(6-Amino-1,3-dimethyl-2,4-dioxo1,2,3,4-tetrahydropyrimidin-5-yl)formamide


O

O N N

H N NH2 O

(A)

100 mg

MM 0494.03

Imp. C (EP): 1,3,9-Trimethyl-3,9-dihydro1H-purine-2,6-dione (Isocaffeine)


O

N N

N N

(A)

50 mg

MM 0577.00

Imp. D (EP): Theobromine


HN O

O N N N

(A)

500 mg

MM 0494.06

Imp. E (EP) as Nitrate: N,1-Dimethyl-4(methylamino)-1H-imidazole-5-carboxamide Nitrate (Caffeidine Nitrate) Imp. F (EP): 1,7-Dimethyl-3,7-dihydro-1H-purine-2,6-dione (Paraxanthine; 1,7-Dimethylxanthine)

O N H HN N N x HNO3

(A)

100 mg

MM 0494.04

O N O N H
O NaO N HN O N N

(D)
N N

50 mg

New MM 0494.10

Sodium 4-[N-Methyl-N-(N-methylaminocarbonyl)amino]1-methylimidazole-5-carboxylate

(A)

50 mg

Candesartan Cilexetil
MM 0776.00 Candesartan Cilexetil
O O N N O O O O N N N NH

(A)

100 mg

MM 0776.01

Imp. A (Pharmeuropa): Ethyl 2-Ethoxy-1-[[2'-(1H-tetrazol5-yl)-4-biphenylyl]methyl]-1H-benzimidazole-7-carboxylate

O O N N O N N N NH

(A)

100 mg

MM 0776.07

Imp. H (EP): (1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl 2-Ethoxy-1-[[2'-[1-(triphenylmethyl)-1Htetrazol-5-yl]biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate (N-Tritylcandesartan Cilexetil)

O O O N N O O O N N N N

(A)

100 mg

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53

Pharmaceutical impurities
Code Product Price
O OH N N O N N N NH

Unit

MM 0776.09

Imp. G (EP): 2-Ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7carboxylic Acid (Candesartan)

(A)

100 mg

MM 0776.08

Trityl Candesartan

O OH N N O N N N N

(A)

100 mg

Capecitabine
MM 0992.00 Capecitabine
HN N O O OH N O O F

(A)

100 mg

OH

MM 0992.02

2,3-O-Carbonyl-5-deoxy-5-fluoroN4-(pentyloxycarbonyl)cytidine
O O O O

O HN N N O F

(A)

100 mg

Captopril
MM 0067.00 Captopril
HS O O N O N OH OH

(A)

500 mg

MM 0067.01

Imp. A (EP): 1,1'-[Disulfanediylbis-[(2S)-2-methyl1-oxopropane-3,1-diyl]]bis[(2S)-pyrrolidine-2-carboxylic] Acid (Captopril Disulfide) Imp. B (EP): (2S)-1-[(2S)-3-Bromo-2methylpropanoyl]pyrrolidine-2-carboxylic Acid Imp. C (EP): (2RS)-2-Methyl-3-sulfanylpropanoic Acid

O N HO O O S S

(A)

100 mg

New MM 0067.07

O Br

O N

OH

(A)

50 mg

MM 0067.02 MM 0067.06 MM 0067.08

O HS OH

(A) (A)
OH

100 mg 100 mg 100 mg

Imp. D (EP): (2RS)-3-Bromo-2-methylpropanoic Acid


Br

Imp. E (EP): (2S)-1-[2-Methylpropanoyl]pyrrolidine-2carboxylic Acid Imp. J (EP) as Hydrate: (2S)-1-[(2S)-3(Acetylsulfanyl)-2-methylpropanoyl]pyrrolidine-2-carboxylic Acid Hydrate Imp. K (Pharmeuropa): (2S)-3-(Acetylthio)-2methylpropanoic Acid Imp. N (EP): 3,3'-Disulfanediylbis[(2S)-2-methylpropanoic] Acid Imp. O (EP): 1,1'-[Propane-2,2-diylbis[sulfanediyl[(2S)-2-methyl-1-oxopropane3,1-diyl]]]bis[(2S)-pyrrolidine-2-carboxylic] Acid Captopril Ethyl Ester
HS O S O O N

O N

OH

(A)

MM 0067.05

OH x H2O

(A)

100 mg

MM 0067.04 MM 0067.15

O S

O OH

(C) (A)
OH

100 mg 50 mg

O HO O S S
O N

New MM 0067.16

HO

O N

O S S

OH

(A)

50 mg

MM 0067.03

O N

on request

54

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Pharmaceutical impurities
Code Product Price Unit

Carbamazepine
MM 0076.00 Carbamazepine
N O NH2

(A)

250 mg

MM 0076.04

Imp. A (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine5-carboxamide (10,11-Dihydrocarbamazepine)

O N NH2

(A)

100 mg

MM 0076.09

Imp. B (EP): 9-Methylacridine


N

(A)

100 mg

MM 0076.12

Imp. C (EP): (5H-Dibenzo[b,f]azepin-5-yl-carbonyl)urea (N-Carbamoylcarbamazepine)

O N N H

O NH2

(A)

100 mg

MM 0076.08

Imp. D (EP): 5H-Dibenzo[b,f]azepine (Iminostilbene)


NH

(B)

100 mg

MM 0076.06

Imp. E (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine (Iminodibenzyl)

(B)
NH

100 mg

MM 0076.05

Imp. G (EP): 10-Bromo-5H-dibenzo[b,f]azepine5-carboxamide (10-Bromocarbamazepine)


Br

O N NH2

(A)

100 mg

MM 0076.01

Carbamazepine 10,11-Epoxide
N O

O NH2

(A)

100 mg

MM 0076.10

10-Hydroxy-10,11-dihydrocarbamazepine
N

O NH2

(A)

100 mg

HO

MM 0076.17

Oxcarbazepine
N

O NH2

(A)

100 mg

Carbasalate Calcium
MM 0133.02 Imp. A (EP): 2-(Acetyloxy)benzoic Anhydride (Acetylsalicylic Anhydride)
O O O O O O O

(A)

100 mg

MM 0133.01

Imp. B (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid (Acetylsalicylsalicylic Acid)


O

O OH O O O

(A)

100 mg

MM 0045.00

Imp. C (EP): Salicylic Acid

O OH OH

(A)

500 mg

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55

Pharmaceutical impurities
Code Product Price
O OH O O OH

Unit

MM 0133.03

Imp. D (EP): 2-[(2-Hydroxybenzoyl)oxy]benzoic Acid (Salicylsalicylic Acid)

(A)

100 mg

Carbendazim
MM 2500.00 Carbendazim
H N N O O NH

(A)

100 mg

MM 2500.01 MM 2500.02

2,3-Diaminophenazine 2-Amino-3-hydroxyphenazine

N N N N

NH2 NH2 NH2 OH

(A) (A)

100 mg 100 mg

Carbenicillin Sodium
MM 0805.00 Carbenicillin Sodium
O O N H O ONa N S H O ONa

(A)

250 mg

Carbocisteine
MM 0236.00 Carbocisteine
O HO O S NH2 O HO O S O O NH S O OH OH NH2 OH

(A)

500 mg

MM 0236.01

(S)-Carboxymethyl-L-cysteine (R/S)-Sulphoxide Lactam of (S)-Carboxymethyl-L-cysteine

(A)

100 mg

MM 0236.02

(A)

100 mg

MM 0236.03

L-Cysteinesulfinic Acid

O HO S O OH NH2

(C)

100 mg

Carisoprodol
MM 0782.03 Imp. C (EP): 2-Methyl-2-propylpropane-1,3-diol
HO OH

(A)

100 mg

Carvedilol
MM 0291.00 Carvedilol
OH O H N

(A)
O O

100 mg

HN

MM 0291.02

Imp. B (EP): 1,1'-[[2-(2-Methoxyphenoxy)ethyl]nitrilo]bis[3-(9H-carbazol-4-yloxy)propan-2-ol]


OH O N

(A)
OH O O O HN NH

100 mg

MM 0291.03

Imp. C (EP): (2RS)-1-[Benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H-carbazol-4-yloxy)propan-2-ol


O

(A)
OH N O O HN

100 mg

MM 0291.04

Toluene

(C)

100 mg

56

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Pharmaceutical impurities
Code Product Price
O O

Unit

MM 0291.10

4-(2,3-Epoxypropoxy)carbazole

(A)

100 mg

HN

MM 0291.11

2-(2-Methoxyphenoxy)ethylamine Hydrochloride

H2N

O O x HCl

(A)

100 mg

Cefaclor
MM 0326.00 Cefaclor Monohydrate
O NH 2 H N N H S O OH Cl x H2O

(A)

100 mg

MM 0253.12

Imp. A (EP): (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine) Imp. F (EP): 3-Phenylpyrazin-2-ol


N N

NH 2 OH O

(B)

100 mg

MM 0253.08

OH

(A)

100 mg

Cefadroxil Monohydrate
MM 0232.09 Imp. A (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid
HO NH2 OH O

(B)

100 mg

MM 0811.01

Imp. B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ADCA; 7-Aminodesacetoxycephalosporanic Acid)

O O N H2N H S

OH

(A)

100 mg

Cefalexin Monohydrate
MM 0605.00 Cefalexin Monohydrate
NH2 H N O O O N H S OH x H2O

(A)

500 mg

MM 0253.12

Imp. A (EP): (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine) Imp. B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-Aminodesacetoxycephalosporanic Acid; 7-ADCA)

NH 2 OH O

(B)

100 mg

MM 0811.01

O O N H 2N H S

OH

(A)

100 mg

Cefazolin Sodium
MM 0238.00 Cefazolin Sodium
O H N O N H S S S N N O ONa

(A)

100 mg

N N

N N

MM 0238.05

Imp. E (EP): 5-Methyl-1,3,4-thiadiazol-2-thiol (MMTD)


S

SH N N

(A)

100 mg

MM 0238.08

Imp. H (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA)

O O N H2N H S

OH O

(A)

100 mg

Cefetamet
MM 0811.01 7-Aminodesacetoxycephalosporanic Acid
O N H 2N H S O OH

(A)

100 mg

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57

Pharmaceutical impurities
Code Product Price Unit

Cefoperazone Sodium
MM 0853.03 Imp. C (EP): 1-Methyl-1H-tetrazole-5-thiol
N SH N

(A)

100 mg

N N

MM 0238.08

Imp. E (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo5-thia-1-azabicyclo-[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA)

O O N H2N H S

OH O

(A)

100 mg

Cefradine
MM 0811.01 Imp. A (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-Aminodeacetoxycephalosporanic Acid, 7-ADCA)
O O N H2N H S OH

(A)

100 mg

Celecoxib
MM 0344.00 Celecoxib
O O S NH2 N N F F F

(D)

100 mg

MM 0344.02

4-[5-[4-(Hydroxymethyl)phenyl]-3-(trifluoromethyl)1H-pyrazol-1-yl]-benzenesulfonamide

HO O O S NH2 N N F F F
O O O S NH2 N N F F F

(D)

100 mg

MM 0344.03

4-[1-[4-(Aminosulfonyl)phenyl]-3-(trifluoromethyl)1H-pyrazol-5-yl]benzoic Acid

HO

(D)

100 mg

Celiprolol Hydrochloride
MM 0128.00 Celiprolol Hydrochloride
O N N H O O OH H N x HCl

(A)

100 mg

MM 0128.01

Imp. A (EP): 1-[5-Amino-2-[(2RS)3-[(1,1-dimethylethyl)amino]2-hydroxypropoxy]phenyl]ethanone


H2N

O O

OH

H N

(A)

100 mg

MM 0128.03

Imp. C (EP): 1-[3-Acetyl-4-[(2RS)3-[(1,1-dimethylethyl)amino]2-hydroxypropoxy]phenyl]-3-(1,1-dimethylethyl)urea


N H

O O N H
O O N N H O

OH O

H N

(A)

100 mg

MM 0128.10

Imp. D (EP):3-[3-Acetyl-4-[(RS)-3-(diethylamino)2-hydroxypropoxy]phenyl]-1,1-diethylurea

OH N

(D)

100 mg

MM 0128.05

Imp. E (EP): 1,1'-[[(1,1-Dimethylethyl)imino]bis[(2-hydroxypropane-1,3-diyl)oxy(3-acetyl1,4-phenylene)]]bis(3,3-diethylurea)

O O HN O N

OH N

OH O

(D)

50 mg

NH N O

58

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Pharmaceutical impurities
Code Product Price
O O N N H OH

Unit

MM 0128.07

Imp. F (EP): 3-(3-Acetyl-4-hydroxyphenyl)1,1-diethylurea

(A)

100 mg

MM 0128.06

Imp. G (EP): 3-[3-Acetyl-4-[[(RS)-oxiranyl]methoxy] phenyl]-1,1-diethylurea


N

O O N H O O N N H O O O

(A)

100 mg

MM 0128.04

Imp. H (EP): 3-[3-Acetyl-4-[(2RS)-3-bromo2-hydroxypropoxy]phenyl]-1,1-diethylurea (Bromhydrin Compound)

OH Br

(A)

100 mg

MM 0128.11

3-Acetyl-4-hydroxyaniline Hydrochloride

O OH x HCl H2N

(A)

100 mg

MM 0128.58

5-Acetamido-2-hydroxyacetophenone
O N H

O OH

(A)

100 mg

Cethexonium Bromide
MM 0501.01 rac-trans-2-Dimethylaminocyclohexanol Hydrochloride
N OH x HCl

(A)

100 mg

and enantiomer

Cetirizine Dihydrochloride
MM 0380.00 Cetirizine Dihydrochloride
O Cl N x 2 HCl N O OH

(A)

100 mg

MM 0380.01

Imp. A (EP): (RS)-1-[(4-Chlorophenyl)phenylmethyl] piperazine


N Cl NH
N N O x 2 HCl OH

(A)

100 mg

MM 0380.02

Imp. B (EP) as Dihydrochloride: (RS)2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]acetic Acid Dihydrochloride Imp. C (EP) as Dihydrochloride: (RS)-2-[2-[4-[(2-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid Dihydrochloride

Cl

(A)

100 mg

MM 0380.03

O N N Cl x 2 HCl O OH

(A)

100 mg

MM 0380.04

Imp. D (EP): 1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine


Cl N N Cl

(A)

100 mg

MM 0380.05

Imp. E (EP) as Dihydrochloride: (RS)2-[2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]ethoxy]acetic Acid Dihydrochloride (Ethoxycetirizine Dihydrochloride) Imp. F (EP) as Dihydrochloride: [2-[4-[Diphenylmethyl]piperazin-1-yl]ethoxy] acetic Acid Dihydrochloride

Cl N

O O x 2 HCl

OH

(D)

100 mg

MM 0380.06

O N N x 2 HCl O OH

(A)

100 mg

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59

Pharmaceutical impurities
Code Product Price
Cl N x 2 HCl N OH

Unit

MM 0380.11

Imp. G (EP) as Dihydrochloride: 2-[4-[(RS)(4-Chlorophenyl)phenylmethyl]piperazin-1-yl] ethanol Dihydrochloride Isopropyl Ester of Cetirizine

(A)

100 mg

MM 0380.08

O Cl N N O O

(A)

100 mg

MM 0380.09

4-Chlorobenzhydrol
OH Cl

(B)

100 mg

MM 0380.10

4-Chlorobenzophenone
O Cl

(B)

100 mg

MM 0380.13

Cetirizine N-Oxide

Cl N

O N

O O OH

(A)

100 mg

MM 0380.15

Ethyl Ester of Cetirizine Dihydrochloride

O Cl N x 2 HCl N O O

(A)

100 mg

MM 0380.16

Methyl Ester of Cetirizine Dihydrochloride

O Cl N x 2 HCl N O O

(A)

100 mg

MM 0380.17

3-Chlorocetirizine Dihydrochloride ((RS)2-[2-[4-[(3-Chlorophenyl)phenylmethyl]piperazin1-yl]ethoxy]acetic Acid Dihydrochloride)

O N Cl N x 2 HCl O OH

(A)

100 mg

Chlorambucil
MM 0821.00 Chlorambucil
Cl N O OH

(A)

500 mg

Cl

Chloramphenicol
MM 0516.00 Chloramphenicol
Cl Cl O N H OH NO2

(A)

500 mg

OH OH NO2

MM 0516.01

(D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3-propanediol
H2N

(A)

100 mg

OH

Chlordiazepoxide Hydrochloride
New MM 0028.08 Chlordiazepoxide [Controlled Substance]
Cl N N O H N

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
H N Cl N O O

Unit

MM 0028.02

Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro2H-1,4-benzodiazepin-2-one 4-Oxide (Demoxepam)

(A)

100 mg

MM 0028.04

Imp. B (EP): 6-Chloro-2-(chloromethyl)-4-phenylquinazoline 3-Oxide

N Cl N O

Cl

(A)

100 mg

MM 0028.03

Imp. C (EP): (2-Amino-5-chlorophenyl)phenyl-methanone (Aminochlorobenzophenone)

NH2 Cl O

(B)

100 mg

Chlorhexidine Diacetate
MM 0162.00 Chlorhexidine Diacetate
H N Cl H N NH H N NH x2 O OH NH N H N H NH N H Cl

(A)

500 mg

MM 0162.05 MM 0162.07

4-Chloroaniline
Cl

NH2

(B) (A)

100 mg 100 mg

(4-Chlorophenyl)urea
Cl

H N O H N Cl NH2 NH

NH2

MM 0162.08

(4-Chlorophenyl)guanidine Hydrochloride

(C)
x HCl

50 mg

Chlorhexidine Dihydrochloride
MM 0946.00 Chlorhexidine Dihydrochloride
Cl Cl N H H N H N NH NH N H H N NH x 2 HCl NH N H

(A)

500 mg

Chlormezanone
MM 0017.00 Chlormezanone
O S O N O Cl

(A)

250 mg

MM 0017.02

2-(4-Chlorophenyl)-3-methylperhydro-1,3-thiazin-4-one
S N O

Cl

on request

MM 0017.03

4-Chlorobenzaldehyde

O Cl H

(B)

100 mg

Chlorobutanol Hemihydrate
MM 0535.00 Chlorobutanol Hemihydrate
OH Cl Cl x H2O

(A)

500 mg

Cl

Chlorocresol
MM 0459.00 Chlorocresol
Cl OH

(A)

500 mg

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Pharmaceutical impurities
Code Product Price Unit

Chlorphenamine Maleate
MM 0090.00 Chlorphenamine Maleate
Cl O x N O OH OH

(A)

500 mg

MM 0090.03

Imp. A (EP) as Dihydrochloride: 2-(4-Chlorophenyl)4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile Dihydrochloride

Cl N

(D)
x 2 HCl N

100 mg

MM 0090.04 MM 0090.13

Imp. B (EP): N-(Pyridin-2-yl)pyridin-2-amine (2,2'-Dipyridylamine) Imp. C (EP) as Maleate: (3RS)-3-(4-Chloro-phenyl)-Nmethyl-3-(pyridin-2-yl)propan-1-amine Maleate


N Cl

H N N

(A) (A)
OH OH O

100 mg 100 mg

O x NH

MM 0090.05

Imp. D (EP) as Maleate: (2RS)-2-(4-Chloro-phenyl)-4(dimethylamino)-2-(pyridin-2-yl)butanenitrile Maleate

Cl O N x N N O OH OH

(D)

100 mg

MM 0090.11

Chlorphenamine N-Oxide Dihydrochloride

Cl

(A)
x 2 HCl

100 mg

Chlorphenoxamine Hydrochloride
MM 1291.00 Chlorphenoxamine Hydrochloride
O Cl N x HCl

(A)

100 mg

Chlorpromazine Hydrochloride
MM 0420.00 Chlorpromazine Hydrochloride
N S Cl N x HCl

(A)

500 mg

MM 0420.01

Imp. A (EP): 3-(2-Chloro-10H-phenothiazin10-yl)-N,N-dimethylpropan-1-amine S-Oxide (Chlorpromazine Sulfoxide)

(A)
N O S Cl N

100 mg

MM 0420.06

Imp. B (EP) as Dihydrochloride: N-[3-(2-Chloro10H-phenothiazin-10-yl)propyl]-N,N',N'-trimethylpropane-1,3-diamine Dihydrochloride

(A)
N S x 2 HCl Cl N N

100 mg

MM 0290.00

Imp. C (EP) as Hydrochloride: 3-(10H-Phenothiazin10-yl)-N,N-dimethylpropan-1-amine Hydrochloride (Promazine Hydrochloride) Imp. D (EP) as Hydrochloride: 3-(2-Chloro-10Hphenothiazin-10-yl)-N-methylpropan-1-amine Hydrochloride (Desmethylchlorpromazine Hydrochloride)

(A)
N S N x HCl

500 mg

MM 0420.07

(A)
N S Cl NH x HCl

100 mg

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Pharmaceutical impurities
Code Product Price Unit

MM 0420.04

Imp. E (EP): 2-Chloro-10H-phenothiazine


NH S Cl

(A)

100 mg

MM 0420.02

Chlorpromazine Sulphoxide N-Oxide Maleate


N O S Cl N O x

O OH OH O

(B)

10 mg

Chlorprothixene Hydrochloride
MM 1321.01 Imp. A (EP): (RS)-2-Chloro-9-[3-(dimethylamino)propyl]-9H-thioxanthen-9-ol
S Cl OH N

(A)

100 mg

MM 1321.07

Imp. B (EP) as Hydrochloride: N,N-Dimethyl-3(9H-thioxanthen-9-ylidene)propan-1-amine Hydrochloride


S

(A)
N x HCl

50 mg

MM 1321.05

Imp. E (EP): 2-Chloro-9H-thioxanthen-9-one


O S Cl

(A)

100 mg

Chlorquinaldol
MM 0390.00 Chlorquinaldol
OH Cl N

(A)

500 mg

Cl

Chlortalidone
MM 0297.00 Chlortalidone
O H2N S Cl O HO HN O

(A)

250 mg

Chlortetracycline Hydrochloride
MM 0607.00 Chlortetracycline Hydrochloride
OH O H Cl OH O H Cl OH O H HO OH O OH H N OH O OH H N OH O OH H N O NH2 OH x HCl O NH2 OH x HCl O NH2 OH x HCl

(A)

500 mg

MM 0636.00

Imp. B (EP) as Hydrochloride: Demeclocycline Hydrochloride

OH

(A)

250 mg

MM 0452.00

Tetracycline Hydrochloride

OH

(A)

500 mg

Cholecalciferol
MM 0249.02 Imp. B (EP): Cholesta-5,7-dien-3-ol (7,8-Didehydrocholesterol; Provitamin D3) (A) 100 mg

HO

Ciclopirox Olamine
MM 0418.00 Ciclopirox Olamine
OH N O x H2N OH

(A)

250 mg

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Pharmaceutical impurities
Code Product Price
H N

Unit

MM 0418.03

Imp. C (EP): 6-Cyclohexyl-4-methylpyridin-2(1H)-one

(A)
O

50 mg

Cimetidine Hydrochloride
MM 0020.00 Cimetidine
HN N S N H N N S N H N N S N H
NH2 N S N H N H x 2 HCl

N N N H

(A)

500 mg

MM 0020.08

Imp. A (EP): 3-Cyano-2-methyl-1-[2[[(5-methyl-1H-imidazol-4-yl)methyl]sulphanyl]ethyl]isothiourea Imp. B (EP): 3-Cyano-2-methyl-1-[2-[[(5-methyl1H-imidazol-4-yl)methyl]sulphanyl]ethyl]isourea

(A)

100 mg

HN

N S

MM 0020.12

(A)

100 mg

HN

N O

MM 0020.03

Imp. C (EP) as Dihydrochloride: 1-[(Methylamino)[[2-[[(5-methyl-1H-imidazol-4-yl)methyl]sulphanyl]ethyl]amino]methylene]urea Dihydrochloride (Cimetidine Amide Dihydrochloride) Imp. D (EP) as Dihydrochloride:1-Methyl3-[2-[[(5-methyl-1H-imidazol4-yl)methyl]sulphanyl]ethyl]guanidine Dihydrochloride Imp. E (EP): 2-Cyano-1-methyl-3-[2-[[(5-methyl1H-imidazol-4-yl)methyl]sulphinyl]ethyl]guanidine (Cimetidine Sulphoxide) Imp. G (EP): 2-Cyano-1,3-dimethylguanidine

O HN N

(A)

100 mg

MM 0020.06

HN

N S N H

NH N H x 2 HCl

(A)

100 mg

MM 0020.04

N N HN O S N H
N N N H N H

(A)

100 mg

N N H

MM 0020.15

(A)

100 mg

MM 0020.07

Imp. H (EP): 1,1'-(Disulphanediyldiethylene)bis (2-cyano-3-methylguanidine)


N H

N N N H S S

(A)
H N N N H N

100 mg

MM 0020.50 MM 0020.10 MM 0056.01

Imp. J (EP) as Dihydrobromide: 2-[[(5-Methyl-1Himidazol-4-yl)methyl]sulphanyl]ethanamine Dihydrobromide 1,1-Dimethyl-3-cyanoguanidine Cyanoguanidine

HN

N S NH2 x 2 HBr

(A) (A)

100 mg 100 mg 100 mg

H N NH N

H2 N

H N NH N

(B)

Cinchocaine Hydrochloride
MM 0604.00 Cinchocaine Hydrochloride
O N O N H N x HCl

(A)

500 mg

MM 0604.02

Imp. B (EP): 2-Hydroxyquinoline-4-carboxylic Acid

O HO N OH

(A)

100 mg

New MM 0604.03

Imp. C (EP): N-[2-(Diethylamino)ethyl]-2hydroxyquinoline-4-carboxamide

O HO N N H N

(A)

50 mg

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Code Product Price
O O N N H N O

Unit

MM 0604.05

Cinchocaine N-Oxide

(A)

100 mg

Cinnarizine
MM 1038.01 Imp. A (EP): 1-(Diphenylmethyl)piperazine
N NH

(A)

100 mg

MM 1038.03

Imp. B (EP): (Z)-1-(Diphenylmethyl)-4(3-phenylprop-2-enyl)piperazine


N N

(A)

100 mg

MM 1038.04

Imp. C (EP): (4-(Diphenylmethyl)-1,1-bis[(E)3-phenylprop-2-enyl]piperazinium Chloride

N+ N Cl-

(A)

100 mg

MM 1038.06

Imp. E (EP): 1,4-Bis(diphenylmethyl)piperazine


N N

(A)

100 mg

Ciprofloxacin Hydrochloride
MM 0018.06 Ciprofloxacin Hydrochloride Monohydrate
HN N F O O N OH x HCl x H2O

(A)

500 mg

MM 0018.01

Imp. A (EP): 7-Chloro-1-cyclopropyl-6-fluoro-4-oxo1,4-dihydroquinoline-3-carboxylic Acid (Fluoroquinolonic Acid) Imp. B (EP): 1-Cyclopropyl-4-oxo-7-(piperazin-1-yl)1,4-dihydroquinoline-3-carboxylic Acid (Desfluoro Compound) Imp. C (EP): 7-(2-Aminoethylamino)-1-cyclopropyl-6fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid (Ethylenediamine Compound) Imp. D (EP): 7-Chloro-1-cyclopropyl-4-oxo-6(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid

(A)
Cl F O O N OH

100 mg

MM 0018.05

HN N N OH O O

(A)

100 mg

MM 0018.04

H2 N

H N F

(D)
N OH O O

50 mg

MM 0018.02

(D)
Cl N HN O
HN N F O N

50 mg

N OH O

MM 0018.03

Imp. E (EP): 1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)quinolin-4(1H)-one (Decarboxylated Compound)

(A)

100 mg

MM 0018.10

6-(2-Aminoethylamino)-7-chloro-1-cyclopropyl-4-oxo1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride


H2N

(D)
Cl N H N OH O O x HCl

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Citalopram Hydrobromide
MM 0242.00 Citalopram Hydrobromide
F x HBr

(A)

250 mg

N O N

MM 0242.14

Imp. A (EP): (1RS)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxamide (CitalopramAmide)


H2N O

(A)

100 mg

N O

MM 0242.17

Imp. C (EP): (3RS)-6-Cyano-3-[3-(dimethylamino)propyl]-3-(4-fluorophenyl)isobenzofuran-1(3H)-one

(A)

100 mg

N O N O

MM 0242.09

Imp. D (EP) as Hydrochloride: (1RS)-1-(4-Fluorophenyl)1-[3-(methylamino)propyl]-1,3-dihydroisobenzofuran5-carbonitrile Hydrochloride (Desmethylcitalopram Hydrochloride)


N

F x HCl N H

(A)

100 mg

MM 0242.12

Imp. E (EP) as Oxalate: 3-[(1RS)-5-Chloro1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]N,N-dimethylpropan-1-amine Oxalate

F HO x N O Cl HO O O

(A)

50 mg

MM 0242.13

Imp. F (EP) as Hydrogen Oxalate: 3-[(1R)-5-Bromo1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]N,N-dimethylpropan-1-amine Hydrogen Oxalate

F x

HO HO N O

O O

(A)

100 mg

Br

Citric Acid Anhydrous


MM 0988.00 Citric Acid Anhydrous
HO O O HO OH O OH

(A)

250 mg

Citric Acid Monohydrate


MM 0575.00 Citric Acid Monohydrate
HO O O HO OH O OH x H 2O

(A)

500 mg

Clarithromycin
MM 0057.05 Imp. E (EP): 6,11-Di-O-methylerythromycin A
O OO OH N OH OO O O OH O O O

(D)

100 mg

Clindamycin Hydrochloride
MM 0259.00 Clindamycin Hydrochloride
N H N O HO OH S OH Cl

(A)
x HCl

100 mg

66

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Pharmaceutical impurities
Code Product Price Unit

Clioquinol
MM 0312.00 Clioquinol
OH I N

(A)

500 mg

Cl

MM 0312.01

Imp. A (EP): 5-Chloroquinolin-8-ol

OH N

(B)

100 mg

Cl

MM 0312.02

Imp. B (EP): 5,7-Dichloroquinolin-8-ol

OH Cl N

(B)

100 mg

Cl

MM 0312.03

Imp. C (EP): 5,7-Diiodoquinolin-8-ol

OH I N

(B)

100 mg

Clobenzorex Hydrochloride
MM 0649.00 Clobenzorex Hydrochloride
H N Cl

(A)
x HCl

500 mg

Clobetasol Propionate
MM 0769.00 Clobetasol Propionate
HO O O Cl O

(A)

100 mg

F O

MM 0200.01

Imp. G (EP): 21-Chloro-9-fluoro-11,17-dihydroxy-16methylpregna-1,4-diene-3,20-dione (Clobetasol)

O HO

Cl

(A)

100 mg

OH

F O

MM 0202.04

Imp. K (EP):9-Fluoro-11,17-dihydroxy16-methyl-3,20-dioxopregna-1,4-dien21-yl Propanoate (Betamethasone 21-Propionate)


O

O O HO O

(A)

100 mg

OH

Clobutinol Hydrochloride
MM 0038.00 Clobutinol Hydrochloride
OH Cl N

on request
x HCl

MM 0038.01

1-Dimethylamino-2-methylbutan-3-one
O

(A)

100 mg

Clomifene Citrate
MM 0650.00 Clomifene Citrate
O Cl and Z-Isomer N x O OH OH O OH OH O

(A)

250 mg

MM 0650.01

Clomifene N-Oxide Hydrochloride


O Cl and Z-Isomer x HCl N O

(A)

100 mg

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67

Pharmaceutical impurities
Code Product Price Unit

MM 0650.03

Desethylclomifene Hydrochloride
O Cl and Z-Isomer x HCl N H

(A)

100 mg

Clomipramine Hydrochloride
MM 0545.00 Clomipramine Hydrochloride
Cl

(A)
N N x HCl

500 mg

MM 0545.01

Imp. A (EP) as Dihydrochloride: N-[3-(3Chloro-10,11-dihydro-5H-dibenzo[b,f]azepin5-yl)propyl]-N,N',N'-trimethylpropane-1,3diamine Dihydrochloride

Cl

on request
N N N

x 2 HCl

MM 0077.00

Imp. B (EP) as Hydrochloride: Imipramine Hydrochloride

(A)
N N x HCl

500 mg

MM 0545.03

Imp. C (EP) as Hydrochloride: 3-(3-Chloro-5Hdibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine Hydrochloride

Cl

(C)
N N x HCl

10 mg

MM 0545.04

Imp. D (EP) as Hydrochloride: 3-(3,7-Dichloro10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,Ndimethylpropan-1-amine Hydrochloride

Cl

(A)
N N x HCl

10 mg

Cl

MM 0076.06

Imp. E (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine (Iminodibenzyl)

(B)
NH

100 mg

MM 0545.06

Imp. F (EP): 3-Chloro-10,11-dihydro-5H-dibenzo[b,f]azepine

Cl

(A)
NH

100 mg

MM 0545.07

Imp. G (EP): 3-Chloro-5-(prop-2-enyl)-10,11-dihydro-5Hdibenzo[b,f]azepine

Cl

(C)
N

50 mg

MM 0545.08

Desmethylclomipramine Hydrochloride

Cl

(A)
N N H x HCl

100 mg

MM 0545.09

Clomipramine N-Oxide

Cl

on request
N N

68

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Pharmaceutical impurities
Code Product Price
Cl

Unit

MM 0545.13

3-Chloro-10-[3(dimethylamino)propyl]-9-acridanone

(A)
N N

100 mg

Clonazepam
New MM 0945.00 Clonazepam [Controlled Substance]
O 2N H N N Cl O

(A)

100 mg

MM 0945.01

Imp. A (EP): (2-Amino-5-nitrophenyl)(2chlorophenyl)methanone

NH2 O2 N O Cl

(A)

100 mg

MM 0945.02

Imp. B (EP): 3-Amino-4-(2-chlorophenyl)-6nitroquinolin-2(1H)-one


O2 N

H N

O NH2 Cl

(A)

50 mg

MM 0945.04

Methylclonazepam
O2 N

N N

(A)

50 mg

Cl

MM 0945.05

2-Bromo-2'-(2-chlorobenzoyl)-4'-nitroacetanilide
O2 N

O NH O

Br

(A)

50 mg

Cl

Clonidine Hydrochloride
MM 0983.00 Clonidine Hydrochloride
Cl Cl HN N N H
HN O O N

(A)
x HCl

100 mg

MM 0983.04

Imp. A (EP): 1-Acetylimidazolidin-2-one

(A)

100 mg

MM 0983.03

Imp. B (EP): 1-Acetyl-2-[(2,6-dichlorophenyl)amino]-4,5-dihydro-1H-imidazole


Cl

Cl N H

N N O

(A)

50 mg

MM 0006.21

Imp. C (EP): 2,6-Dichloroaniline

Cl NH2 Cl

(B)

100 mg

MM 0983.02

1-(2,6-Dichlorophenyl)thiourea
Cl

Cl N H

S NH2

(A)

100 mg

Clopidogrel Hydrogen Sulphate


MM 0455.10 Clopidogrel Hydrogen Sulphate
Cl N S O O x H2SO4

(A)

100 mg

MM 0455.09

Clopidogrel Alcohol
Cl N S OH

(D)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

MM 0455.13

Imp. B (EP) as Racemate Hydrogen Sulfate: Methyl (2RS)-(2-Chlorophenyl)[4,7-dihydrothieno[2,3-c]pyridin-6(5H)-yl]acetate Hydrogen

(A)
Cl S N O O x H2SO4

100 mg

MM 0455.12

Imp. C (EP) as Hydrogen Sulfate: Methyl (2R)-(2-Chlorophenyl)[6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]acetate Hydrogen Sulfate


S

(A)
Cl N O O x H2SO4

100 mg

Clotrimazole
MM 0015.00 Clotrimazole
Cl

(A)
N N

500 mg

MM 0015.01

Imp. A (EP): (2-Chlorophenyl)diphenylmethanol


Cl OH

(A)

100 mg

MM 0015.10

Imp. B (EP): 1-[(4-Chlorophenyl)diphenylmethyl]1H-imidazole

Cl

(A)

100 mg

N N

MM 0015.03

Imp. C (EP): 1-Chloro-2-(chlorodiphenylmethyl)benzene


Cl Cl
H N N

(A)

100 mg

MM 0015.02 MM 0015.06

Imp. D (EP): Imidazole Imp. E (EP): (2-Chlorophenyl)phenylmethanone (2-Chlorobenzophenone)


Cl O

(B) (A)

100 mg 100 mg

MM 0015.11

Imp. F (EP): 1-(Triphenylmethyl)-1H-imidazole (Deschloroclotrimazole)


N N

(A)

100 mg

MM 0015.04

(2-Chlorophenyl)diphenylmethane
Cl

(A)

100 mg

MM 0015.05

(2-Chlorophenyl)diphenylmethyl Ethyl Ether

(A)

100 mg

Cl

MM 0015.07

(2-Chlorophenyl)phenyldichloromethane
Cl Cl Cl

(A)

100 mg

MM 0015.08

(2-Chlorophenyl)trichlormethane
Cl Cl Cl Cl

(A)

100 mg

MM 0015.09

1-[(2-Chlorophenyl)diphenylmethyl]-1H-pyrazole

(C)

50 mg

Cl

Cloxacillin Sodium
MM 0682.00 Cloxacillin Sodium Monohydrate
Cl O N O O H N N S H x H2O O ONa

(A)

500 mg

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Pharmaceutical impurities
Code Product Price
O O N H2N S H
Cl N

Unit

MM 0026.04

Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) Imp. D (EP): 3-(2-Chlorophenyl)-5-methylisoxazole-4carboxylic Acid

OH

(B)

100 mg

MM 0682.04

(A)
OH

100 mg

O O

Cloxiquine
MM 0391.00 Cloxiquine
OH N

(A)

500 mg

Cl

Clozapine
MM 0480.00 Clozapine
Cl N HN N N

(A)

100 mg

MM 0480.01

Imp. A (EP): 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4] diazepin-11-one

Cl

H N HN

(A)

100 mg

MM 0480.03

Imp. C (EP): 8-Chloro-11-(piperazin-1-yl)-5Hdibenzo[b,e][1,4]diazepine

Cl N HN N

NH

(A)

100 mg

Cocaine Hydrochloride
New MM 1345.00 Cocaine Hydrochloride [Controlled Substance]
N O O O O x HCl

(A)

100 mg

New MM 1345.04

Benzoylecgonine [Controlled Substance]

O OH O O

(A)

100 mg

Codeine
MM 0442.00 Codeine Phosphate Hemihydrate [Controlled Substance]
O O N x H3 PO 4 x H2 O OH N x H2 O O O OH N

(A)

100 mg

MM 0004.00

Codeine Monohydrate [Controlled Substance]

(A)

100 mg

MM 0004.03

Imp. A (EP): 7,8-Didehydro-4,5-epoxy-3,6-dimethoxy17-methylmorphinan (O-Methylcodeine) [Controlled Substance]


O O

(A)

100 mg

MM 0037.00

Imp. B (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]


HO O

N x HCl x 3 H2O OH

(A)

250 mg

MM 0280.00

Imp. B (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]


HO O

N x H 2SO 4x 5 H2O

(A)

250 mg

OH 2

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71

Pharmaceutical impurities
Code Product Price
N HO O O

Unit

MM 0037.02

Imp. C (EP): 7,7',8,8'-Tetradehydro-4,5:4',5'-diepoxy3,3'-dimethoxy-17,17'-dimethyl-2,2'-bimorphinanyl-6,6'diol (Codeine Dimer; Dimethyl Pseudomorphine)

(A)

100 mg

O N

OH

MM 0004.01

Codeine N-Oxide [Controlled Substance]

O N

(A)

250 mg

O N

OH

MM 0004.02

Codeinone

(A)

100 mg

O N

MM 0004.04

Codeimethine
O HN

(C)

50 mg

OH

MM 0004.05

Norcodeine [Controlled Substance]

(A)

100 mg

O N

OH

MM 0004.06

Acetylcodeine [Controlled Substance]

(A)

100 mg

O O

MM 0004.08

Isocodeine [Controlled Substance]

(A)

100 mg

O N

OH

MM 0037.01

Pseudomorphine
HO O OH

(A)

100 mg

HO N

OH

Colchicine
MM 1083.00 Colchicine
O NH O O O O O

(A)

100 mg

MM 1083.04

Imp. D (EP): N-[(7S,12aRa)-3-(-D-Glucopyranosyloxy)-1,2,10-trimethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]acetamide (Colchicoside)

HO O OH HO OH O NH O O O O O

(A)

100 mg

New MM 1083.06

Imp. F (EP): N-[(7S,12aRa)-10-Hydroxy-1,2,3trimethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a] heptalen-7-yl]acetamide (Colchiceine)

O NH O O OH O O

(A)

50 mg

Cortisone
MM 0214.00 Cortisone
O O OH OH

(A)

500 mg

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Pharmaceutical impurities
Code Product Price Unit

Cortisone Acetate
MM 0186.00 Cortisone Acetate
O O OH O O

(A)

500 mg

MM 0187.00

Imp. A (EP): Hydrocortisone Acetate


HO

O OH O

(A)

500 mg

Cyclizine Hydrochloride
MM 1265.01 MM 0490.02 Imp. A (EP): 1-Methylpiperazine
HN N

(A) (B)

100 mg 100 mg

Imp. B (EP): Diphenylmethanol (Benzhydrol)


OH

Cyclobenzaprine Hydrochloride
MM 0062.02 Cyclobenzaprine Hydrochloride
N x HCl

(A)

100 mg

Cyclopentolate Hydrochloride
MM 0580.00 Cyclopentolate Hydrochloride
HO O O N x HCl

(A)

500 mg

MM 0580.01

Imp. A (EP): (2RS)-(1-Hydroxycyclopentyl)(phenyl) acetic Acid


HO

O OH

(A)

100 mg

MM 0160.03 MM 0580.03

Imp. B (EP): Phenylacetic Acid [Drug Precursor] Imp. C (EP) as Hydrochloride: 2-(Dimethylamino)ethyl Phenylacetate Hydrochloride
O O N

O OH
x HCl

(B) (A)

100 mg 100 mg

Cynarine
MM 0048.01 3,4-Dihydroxycinnamic Acid (Caffeic Acid)
O HO HO OH

(B)

100 mg

Cyproheptadine Hydrochloride
MM 0609.00 Cyproheptadine Hydrochloride Sesquihydrate
N x HCl x 1 /2 H2O
1

(A)

500 mg

MM 0609.01

Imp. A (EP): 5H-Dibenzo[a,d][7]annulene (Dibenzocycloheptene)

(A)

50 mg

MM 0062.01

Imp. B (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-one (Dibenzosuberone)

(B)
O

100 mg

MM 0609.07

Imp. C (EP) as Hydrochloride: 5-(1-Methylpiperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5ol Hydrochloride

OH

N x HCl

(A)

50 mg

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73

Pharmaceutical impurities
Code Product Price Unit

MM 0609.02

5H-Dibenzo[a,d]cyclohepten-5-one (Dibenzosuberenone)

(C)
O

100 mg

MM 0609.04

Demethylcyproheptadine Hydrochloride

NH x HCl

(A)

100 mg

MM 0609.05

Cyproheptadine -N-Oxide

O N

(A)

100 mg

MM 0609.06

Cyproheptadine -N-Oxide

O N

(A)

100 mg

Cyproterone Acetate
MM 0215.00 Cyproterone Acetate
O O O O Cl

(A)

250 mg

Dacarbazine
MM 1289.00 Dacarbazine
N HN N N N O NH2

(A)

50 mg

MM 1289.02

Imp. B (EP): 5-Amino-1H-imidazole-4-carboxamide

HN H2N

N NH2 O

(A)

100 mg

MM 0056.06

Imp. D (EP) as Hydrochloride: N-Methylmethanamine Hydrochloride

H N

x HCl

(C)

100 mg

DDT
MM 2513.01 2,2-Bis(4-chlorophenyl)-1-chloroethane
Cl

(A)

100 mg

Cl

Cl

MM 2513.02

1-Chloro-3-[1-(4-chlorophenyl)ethyl]benzene

Cl Cl

(A)

100 mg

MM 2513.05

1,1-Bis(4-chlorophenyl)ethane
Cl Cl

(A)

100 mg

Delorazepam
New MM 1371.00 Delorazepam [Controlled Substance]
Cl H N N Cl O

(A)

100 mg

Dembrexine Hydrochloride Monohydrate


MM 1200.03 Imp. C (EP): 3,5-Dibromo-2-hydroxybenzaldehyde
Br O OH Br
O OH

(A)

100 mg

MM 1200.04

Imp. D (EP): 2-Hydroxybenzaldehyde (Salicylaldehyde)

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
Br OH Br Br

Unit

MM 1200.05

Imp. E (EP): 2,4,6-Tribromophenol

(A)

100 mg

Demeclocycline Hydrochloride
MM 0636.00 Demeclocycline Hydrochloride
OH O H Cl OH OH O OH H N O NH2 OH x HCl

(A)

250 mg

Desipramine Hydrochloride
MM 0589.00 Desipramine Hydrochloride
N N H x HCl

(A)

250 mg

MM 0077.00

Imipramine Hydrochloride
N N x HCl

(A)

500 mg

MM 0076.06

Iminodibenzyl
NH

(B)

100 mg

Dexamethasone
MM 0213.00 Dexamethasone
HO O OH OH

(A)

250 mg

F O

MM 0200.00

Imp. B (EP): Betamethasone


HO

O OH OH

(A)

250 mg

F O

MM 0213.01

Imp. C (EP): 9--Fluoro-11,17,21trihydroxy-16-methylpregn-4-ene-3,20-dione

O HO OH OH

(D)

50 mg

F O

MM 0445.00

Imp. G (EP): Dexamethasone Acetate


HO

O OH O

(A)

250 mg

F O

Dexamethasone Acetate
MM 0445.00 Dexamethasone Acetate
HO O OH O O

(A)

250 mg

F O

MM 0213.00

Imp. A (EP): 9-Fluoro-11,17,21-trihydroxy16-methylpregna-1,4-diene-3,20-dione (Dexamethasone)


O

O HO OH OH

(A)

250 mg

MM 0201.00

Imp. D (EP): 9-Fluoro-11,17-dihydroxy-16methyl-3,20-dioxopregna-1,4-dien-21-yl Acetate (Betamethasone Acetate)


O

O HO OH O

(A)

250 mg

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75

Pharmaceutical impurities
Code Product Price Unit

Dexamethasone Sodium Phosphate


MM 0210.00 Dexamethasone Sodium Phosphate
HO O OH O O P ONa ONa

(A)

250 mg

F O

MM 0213.00

Imp. A (EP): 9-Fluoro-11,17,21-trihydroxy-

O HO OH OH

16-methylpregna-1,4-diene-3,20-dione (Dexamethasone)

(A)

250 mg

F O

MM 0303.00

Imp. B (EP) as Sodium Salt: 9-Fluoro-11,17dihydroxy-16-methyl-3,20-dioxopregna-1,4dien-21-yl Dihydrogen Phosphate Disodium Salt (Betamethasone Sodium Phosphate)
O

O HO OH

O O P

ONa ONa

(A)

250 mg

Dexchlorpheniramine Maleate
MM 1114.00 Dexchlorpheniramine Maleate
Cl O x N N O OH OH

(A)

100 mg

MM 0059.00

Imp. A (EP) as Maleate: (3RS)-N,N-Dimethyl-3phenyl-3-(pyridin-2-yl)propan-1-amine Maleate (Pheniramine Maleate)

O x N O OH OH

(A)

100 mg

Dexpanthenol
New MM 1352.04 D,L-Pantolactone
O HO O

(A)

100 mg

MM 1352.05

Calcium (D,L)-Pantoate (Calcium (RS)-2,4-Dihydroxy3,3-dimethylbutyrate)

O HO OH OCa2+ 2

(A)

50 mg

Dextroamphetamine Sulfate
New MM 1359.00 Dextroamphetamine Sulfate [Controlled Substance]
N O O O O x HCl

(A)

100 mg

Dextromethorphan Hydrobromide
MM 0033.00 Dextromethorphan Hydrobromide Monohydrate
N x HBr x H2 O O

(A)

500 mg

MM 0033.10

Imp. A (EP) as Hydrochloride: ent-3-Methoxymorphinan Hydrochloride


O

HN x HCl

(A)

100 mg

MM 0033.09

Imp. B (EP) as (L)-Tartrate: ent-17-Methylmorphinan-3-ol (L)-Tartrate


HO

N
x

(A)
OH HO O OH O OH

100 mg

MM 0033.02

Imp. C (EP): ent-3-Methoxy-17-methylmorphinan-10-one

(D)

100 mg

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Pharmaceutical impurities
Code Product Price
O N x HCl

Unit

MM 0033.11

Dextromethorphan N-Oxide Hydrochloride

(A)

100 mg

Dextropropoxyphene Hydrochloride
MM 0098.01 Dextropropoxyphene Hydrochloride [Controlled Substance]
N O O x HCl

(A)

50 mg

MM 0098.00

Dextropropoxyphene [Controlled Substance]

N O O

(A)

50 mg

MM 0098.06

Imp. A (EP): (2S,3R)-4-(Dimethylamino)-1,2-diphenyl3-methylbutan-2-ol

(A)

100 mg

OH

MM 0098.07

Imp. B (EP) as Hydrochloride: (1S,2R)-1-Benzyl3-(dimethylamino)-2-methyl-1-phenylpropyl Acetate Hydrochloride (Acetoxyphene Hydrochloride)

N O O x HCl

(A)

100 mg

MM 0098.08

Imp. C: (EP) as Hydrochloride: (1S,2R)-1-Benzyl3-(dimethylamino)-2-methyl-1-phenyl-propyl Butanoate Hydrochloride (Butyroxyphene Hydrochloride)

N O O x HCl

(A)

50 mg

MM 0291.04 MM 0098.11

Toluene Imp. F (EP) as Hydrochloride: (2RS)-3-(Dimethylamino)-2-methyl-1-phenylpropan-1-one Hydrochloride

(C) (A)
N O x HCl

100 mg 50 mg

Diazepam
MM 0023.00 Diazepam [Controlled Substance]
Cl N N O

(A)

100 mg

MM 0023.02

Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance]

H N Cl N

(A)

100 mg

MM 0023.04

Imp. B (EP): 2-Chloro-N-(4-chloro-2-benzoylphenyl)-Nmethylacetamide


Cl

O N O

Cl

(A)

100 mg

MM 0023.03

Imp. C (EP): 3-Amino-6-chloro-1-methyl-4-phenylquinolin2(1H)-one


Cl

O NH2

(A)

100 mg

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77

Pharmaceutical impurities
Code Product Price
NH Cl O

Unit

MM 0023.01

Imp. D (EP): [5-Chloro-2-(methylamino)phenyl]phenylmethanone (5-Chloro-2-(methylamino)benzophenone)

(B)

100 mg

MM 0023.05

2'-Benzoyl-2,4'-dichloroacetanilide

O NH Cl O

Cl

(A)

100 mg

Dibutyl Sebacate
MM 0925.00 Dibutyl Sebacate
O O

(A)

500 mg

Dichlorobenzyl Alcohol
MM 0739.01 Bis-(2,4-dichlorobenzyl)Ether
Cl Cl O Cl Cl

(A)

100 mg

Diclofenac Sodium
MM 0006.00 Diclofenac Sodium
O ONa

(A)

500 mg

NH Cl Cl

MM 0006.01

Imp. A (EP): 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one


N Cl

O Cl

(A)

100 mg

MM 0006.03

Imp. B (EP): 2-[(2,6-Dichlorophenyl)amino]benzaldehyde


Cl

O NH Cl

(A)

100 mg

MM 0006.04

Imp. C (EP): [2-[(2,6-Dichlorophenyl)amino]phenyl]methanol


Cl

OH NH Cl

(A)

100 mg

MM 0006.09

Imp. D (EP): 2-[2-[(2-Bromo-6-chlorophenyl)amino]phenyl]acetic Acid


O NH Br

OH

(D)

100 mg

Cl

MM 0006.05

Imp. D (EP) as Sodium Salt: Sodium 2-[2-[(2-Bromo6-chlorophenyl)amino]phenyl]acetate


Br

ONa O NH Cl

(D)

100 mg

MM 0006.02 MM 0006.06

Imp. E (EP): 1,3-Dihydro-2H-indol-2-one


N H

(B) (C)

100 mg 10 mg

1-(2-Bromo-6-chlorophenyl)indolin-2-one
N Br

O Cl

MM 0006.10

Methyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Methyl Ester of Diclofenac)


Cl

O O NH Cl

(A)

100 mg

MM 0006.11

Ethyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Ethyl Ester of Diclofenac)


Cl

O O NH Cl

(A)

100 mg

78

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Pharmaceutical impurities
Code Product Price
O O NH Cl Cl

Unit

MM 0181.06

Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Isopropyl Ester of Diclofenac)

(A)

100 mg

MM 0006.12

2-(2,6-Dichlorophenylamino)benzoic Acid
Cl

O OH NH Cl

(A)

100 mg

MM 0006.15

2,6-Dichlorodiphenylamine
NH Cl Cl

(A)

100 mg

MM 0006.16

2-Bromo-6-chlorodiphenylamine
NH Br Cl

(A)

100 mg

MM 0006.17

1-(2,6-Dichlorophenyl)indolin-2,3-dione
Cl

O O N Cl

(A)

100 mg

MM 0006.18

Diclofenac Potassium
O NH Cl

OK

(A)

100 mg

Cl

MM 0006.19

2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide
Cl

Cl N O Cl

(A)

100 mg

MM 0006.20

2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid (Diclofenac)


Cl

OH O NH Cl

(A)

100 mg

MM 0006.21

2,6-Dichloroaniline

NH2 Cl Cl

(B)

100 mg

MM 0006.22

2-Bromo-6-chloroaniline

NH2 Br Cl

on request

MM 0006.27

N-Acetyl-N-phenyl-2,6-dichloroaniline
N Cl

(A)
Cl

100 mg

MM 0006.28

Diethyl Phthalate

O O O O

(C)

100 mg

Dicloxacillin Sodium
MM 0026.04 Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)
O O H2 N N H S OH

(B)

100 mg

Diflucortolone Valerate
MM 0600.00 Diflucortolone Valerate
HO O O O

(A)

100 mg

F O F

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79

Pharmaceutical impurities
Code Product Price Unit

Digitoxin
MM 0336.01 Digitoxigenin
O O

(A)

50 mg

OH HO

Digoxin
MM 0212.00 Digoxin
OH O O

(A)

250 mg

OH OO OO OH OO OH HO OH H

Dihydrocodeine Hydrogen Tartrate


MM 0812.07 Dihydrocodeine Hydrochloride [Controlled Substance]
O N x HCl

(A)

100 mg

OH OH O OH O OH

New MM 0812.00

Dihydrocodeine Hydrogen Tartrate [Controlled Substance]


O

N x HO

(A)

100 mg

OH

MM 0004.00

Imp. A (EP) as Monohydrate: Codeine Monohydrate [Controlled Substance]


O O N

N x H2O

(A)

100 mg

OH

MM 0442.00

Imp. A (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]


O O

(A)
x H3PO4 x 1/2 H2O

100 mg

OH
N x H2SO4 x 5 H2O

MM 0280.00

Imp. B (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]


HO O

(A)

250 mg

OH
N

MM 0037.00

Imp. B (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]


HO O

(A)
x HCl x 3 H2O

250 mg

OH

Diltiazem Hydrochloride
MM 0068.00 Diltiazem Hydrochloride
S O N O O x HCl O

(A)

500 mg

MM 0068.02

Imp. B (EP): (2S,3S)-2-(4-Methoxyphenyl)-4-oxo2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl Acetate


S O N H O

(A)

100 mg

80

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Code Product Price
O

Unit

MM 0068.03

Imp. D (EP) as Hydrochloride: (2S,3S)-2-(4-Methoxyphenyl)5-[2-(methylamino)ethyl]-4-oxo-2,3,4,5-tetrahydro1,5-benzothiazepin-3-yl Acetate Hydrochloride (N-Desmethyldiltiazem Hydrochloride)

(A)
x HCl

100 mg

S O N O O

HN

MM 0068.04

Imp. E (EP):(2S,3S)-3-Hydroxy-2-(4-methoxyphenyl)2,3-dihydro-1,5-benzothiazepin-4(5H)-one
S OH N H O

(A)

100 mg

MM 0068.05

Imp. F (EP):(2S,3S)-5-[2-(Dimethylamino)ethyl]-3hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5benzothiazepin-4(5H)-one

(A)

100 mg

S OH N O

MM 0068.07

Diltiazem Sulphoxide
O S O N

(A)

100 mg

O O

MM 0068.08

Diltiazem Maleate
S O N

O O x O OH OH

(A)

100 mg

O O

Dimenhydrinate
MM 0599.00 Dimenhydrinate
O N x O N N O H N Cl N

(A)

500 mg

MM 0176.00

Imp. A (EP): Theophylline


N O

O H N N N

(A)

500 mg

MM 0599.04

Dimenhydrinate Imp. B (Pharmeuropa): 8-[(2-(Diphenylmethoxy)-ethyl)(methlyl)amino]1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

O N O N H N N N O

(A)

100 mg

MM 0494.00

Imp. C (EP): Caffeine


N O

O N N N

(A)

500 mg

MM 0599.08

Imp. E (EP): 8-Chloro-1,3,7-trimethyl-3,7dihydro-1H-purine-2,6-dione (8-Chlorocaffeine) Imp. F (EP) as Hydrochloride: 2-(Diphenylmethoxy)-N-methylethanamine Hydrochloride (Diphenhydramine Imp. A Hydrochloride; Nordiphenhydramine Hydrochloride) Imp. G (EP) as Hydrochloride: N,N-Dimethyl-2-[(4-methylphenyl)(phenyl)methoxy]ethanamine Hydrochloride (4-Methyldiphenhydramine Hydrochloride)

O N O N N Cl N

(A)

50 mg

MM 0490.03

(A)
O H N x HCl

100 mg

MM 0490.04

(A)
x HCl O N

100 mg

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81

Pharmaceutical impurities
Code Product Price Unit

MM 0640.00

Imp. H (EP) as Hydrochloride: 2-[(RS)-(4Bromophenyl)(phenyl)methoxy]-N,N-dimethylethanamine Hydrochloride (4-Bromodiphenhydramine Hydrochloride; Bromazine Hydrochloride) Imp. I (EP): Diphenylmethanol (Benzhydrol)

(A)
O Br N x HCl

100 mg

MM 0490.02

(B)
OH

100 mg

MM 0630.01

Imp. J (EP): Diphenylmethanone (Benzophenone)


O

(B)

100 mg

MM 0599.14

Imp. K (EP): [Oxybis(methanetriyl)]tetrabenzene (Bis(diphenylmethyl) Ether)


O

(A)

50 mg

MM 0490.00

Diphenhydramine Hydrochloride
O N x HCl

(A)

500 mg

MM 0155.02

8-Chlorotheophylline
N O

H N Cl N

(B)

100 mg

MM 0599.03

8-[N-(2-Diphenylmethoxyethyl)-N,Ndimethylaminium]-1,3-dimethylxanthine inner salt

O N O N NN N O
+

(A)

100 mg

Dimetindene Maleate
MM 0595.01 MM 0595.02 Imp. A (EP): 2-Ethylpyridine Imp. B (EP) as Hydrochloride: 2-(1H-Inden2-yl)-N,N-dimethylethanamine Hydrochloride Imp. D (EP) as Hydrochloride: (2RS)-2-Benzyl4-(dimethylamino)butanoic Acid Hydrochloride
HO O N
N

(B) (A)

100 mg 50 mg

x HCl

New MM 0595.04

(A)
x HCl

50 mg

MM 0595.10

Imp. E (EP) as Hydrochloride: (2RS)-2-[2-(Dimethylamino)ethyl]indan-1-one Hydrochloride


O

(A)
x HCl N

50 mg

MM 0595.06

Imp. F (EP) as Hydrochloride: 2-(3-Butyl-1Hinden-2-yl)-N,N-dimethylethanamine Hydrochloride Imp. G (EP) as Hydrochloride: N,N-Dimethyl2-(3-phenyl-1H-inden-2-yl)ethanamine Hydrochloride

(A)
N x HCl

50 mg

MM 0595.07

(A)
N x HCl

50 mg

New MM 0595.11

Imp. I (EP) as Maleate: N-Methyl-2-[3-[(1RS)1-( yridine-2-yl)ethyl]-1H-inden-2-yl]ethanamine Maleate

O N H x O OH OH

(A)

50 mg

82

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Pharmaceutical impurities
Code Product Price Unit

Diphemanil Metilsulfate
MM 1163.00 Diphemanil Metilsulfate
N+ x O O -O S O

(D)

100 mg

Diphenhydramine Hydrochloride
MM 0490.00 Diphenhydramine Hydrochloride
O N x HCl

(A)

500 mg

MM 0490.03

Imp. A (EP) as Hydrochloride: 2-(Diphenylmethoxy)-Nmethylethanamine Hydrochloride (Nordiphenhydramine Hydrochloride)

(A)
O H N x HCl

100 mg

MM 0490.04

Imp. B (EP) as Hydrochloride: 2-[(RS)(4-Methylphenyl)phenylmethoxy]-N,Ndimethylethanamine Hydrochloride (4-Methyldiphenhydramine Hydrochloride) Imp. C (EP) as Hydrochloride: 2-[(RS)(4-Bromophenyl)phenylmethoxy]-N,Ndimethylethanamine Hydrochloride (Bromazine Hydrochloride)
Br

(A)
O N x HCl

100 mg

MM 0640.00

(A)
O N x HCl

100 mg

MM 0490.02

Imp. D (EP): Diphenylmethanol (Benzhydrol)


OH

(B)

100 mg

MM 0630.01

Imp. E (EP): Diphenylmethanone (Benzophenone)


O

(B)

100 mg

MM 0490.01

Diphenhydramine N-Oxide
O N O

(A)

100 mg

Diphenylpyraline Hydrochloride
MM 0557.00 Diphenylpyraline Hydrochloride
O N x HCl

(A)

500 mg

MM 0155.01

Diphenylpyraline
O N

(A)

100 mg

MM 0490.02

Diphenylmethanol (Benzhydrol)
OH

(B)

100 mg

MM 0630.01

Diphenylmethanone (Benzophenone)
O

(B)

100 mg

MM 0557.04

Diphenylpyraline N-Oxide
O N O

(A)

100 mg

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83

Pharmaceutical impurities
Code Product Price Unit

MM 0468.04

N-Desmethyldiphenylpyraline Hydrochloride (4-(Diphenylmethoxy)piperidine Hydrochloride)


O

(A)
NH x HCl

100 mg

Dipipanone Hydrochloride
MM 0760.01 1,1-Diphenylbut-1-ene (A) 100 mg

MM 0760.02

1-(1-Methyl-3,3-diphenylpropyl)piperidine Hydrochloride
x HCl N

(A)

100 mg

Dipotassium Clorazepate
MM 0028.03 Imp. A (EP): (2-Amino-5-chlorophenyl)phenylmethanone (Aminochlorobenzophenone)
NH 2 Cl O

(B)

100 mg

MM 0023.02

Imp. B (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance]

H N Cl N

(A)

100 mg

Diprafenon Hydrochloride
MM 0428.01 2'-Hydroxy-3-phenylpropiophenone
O

(A)

100 mg

OH

Diprenorphine
New MM 1384.00 Diprenorphine
N

(D)

50 mg

OH HO O O

Diprophylline
MM 0176.01 Imp. A (EP): N-Methyl-5-(methylamino)-1Himidazole-4-carboxamide (Theophyllidine)
O N H HN H N N

(A)

100 mg

MM 0176.00

Imp. B (EP): 1,3-Dimethyl-3,7-dihydro-1Hpurine-2,6-dione (Theophylline)


O

O N N H N N

(A)

500 mg

MM 0603.00

Imp. C (EP): 7-(2-Hydroxyethyl)-1,3-dimethyl3,7-dihydro-1H-purine-2,6-dione (Etofylline)


O

O N N N N OH

(A)

500 mg

Dipyridamole
MM 0462.03 Imp. C (EP): 2,2'-[[6-Chloro-4,8-di(piperidin-1yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol
N Cl N N OH N N N N OH

(A)

100 mg

84

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Pharmaceutical impurities
Code Product Price Unit

Disopyramide
MM 0108.00 Disopyramide
N N NH2 O

(A)

500 mg

New MM 0108.03

Imp. B (EP) as Dihydrogen Phosphate: (3RS)N,N-Bis(1-methylethyl)-3-phenyl-3-(pyridin-2yl)propan-1-amine Dihydrogen Phosphate


N

(A)
N x H3PO4

50 mg

Dithranol
MM 0137.00 Dithranol
OH O OH

(A)

500 mg

MM 0137.04

Imp. A (EP): Anthracen-9(10H)-one (Anthrone)

(A)

100 mg

MM 0137.01

Imp. B (EP): 1,8-Dihydroxyanthracene-9,10-dione (Danthron)

OH

OH

(A)

100 mg

MM 0137.02

Imp. C (EP): 4,4',5,5'-Tetrahydroxy-9,9'-bianthracenyl10,10'(9H,9'H)-dione (Dithranol Dimer)

OH

OH

(A)

100 mg

OH

OH

Dobutamine Hydrochloride
MM 0384.00 MM 0675.02 Imp. A (EP) as Hydrochloride: Dopamine Hydrochloride Imp. B (EP): 4-(4-Hydroxyphenyl)butan-2-one
O HO HO OH NH2 x HCl

(A) (C)

500 mg 100 mg

Dodecylguanidinium Acetate
MM 0451.03 MM 0451.05 Dodecylnitrile Dimethyldodecylamine
N N

(B) (B)

100 mg 100 mg

Domperidone
MM 0107.00 Domperidone
HN O N N N O NH

(D)

100 mg

Cl

MM 0107.06

Imp. A (EP): 5-Chloro-1-(piperidin-4-yl)1,3-dihydro-2H-benzimidazol-2-one

O HN N NH

(A)

100 mg

Cl

MM 0107.05

Imp. B (EP): 4-(5-Chloro-2-oxo-2,3-dihydro1H-benzimidazol-1-yl)-1-formylpiperidine

O N N

O NH

(A)

100 mg

Cl

MM 0107.03

Imp. F (EP): 1,3-Bis[3-[4-(5-chloro-2-oxo2,3-dihydro-1H-benzimidazol-1-yl)piperidin1-yl]propyl]-1,3-dihydro-2H-benzimidazol2-one

O HN N N N

O N N N

O NH

(A)

50 mg

Cl

Cl

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Pharmaceutical impurities
Code Product Price
H N O N H

Unit

MM 0107.07

1,3-Dihydro-2H-benzimidazol-2-one

(B)

100 mg

Donepezil Hydrochloride
MM 0677.00 Donepezil Hydrochloride
N O O O x HCl

(D)

100 mg

MM 0677.01

Donepezil
N O O O

(D)

100 mg

MM 0677.02

2,3-Dihydro-5,6-dimethoxy-2-[(4-piperidinyl)methyl]indan-1-one Hydrochloride

NH O O O x HCl

(A)

100 mg

MM 0677.16

1-Benzyl-4-[(5,6-dimethoxy-1H-inden2-yl)methyl]piperidine
O O

(A)
N

50 mg

New MM 0677.14

Donepezil N-Oxide
O O O

O N

(A)

50 mg

New MM 0677.08

5,6-Dimethoxy-2-[(4-pyridyl)methyl]indan-1-one
O O

N O

(A)

100 mg

New MM 0677.09

1,1-Dibenzyl-4-[(5,6-dimethoxy-1oxo-2,3-dihydro1H-inden-2-yl)methyl]piperidinium Bromide
N+ O O O

Br-

(A)

50 mg

Dopamine Hydrochloride
MM 0384.00 MM 0384.02 Dopamine Hydrochloride Imp. A (EP) as Hydrochloride: 5-(2-Aminoethyl)2-methoxyphenol Hydrochloride (4-O-Methyldopamine Hydrochloride) Imp. C (EP): 2-(3,4-Dimethoxyphenyl)ethanamine (R,S)--Methyldopamine Hydrobromide
HO HO HO HO HO O NH2 x HCl NH2 x HCl

(A) (A)

500 mg 100 mg

MM 0384.04 MM 0384.01

O O
NH2

NH2

(A) (A)

100 mg 100 mg

x HBr

Dorzolamide Hydrochloride
MM 0403.00 Dorzolamide Hydrochloride
O H2N HN O S S O O S x HCl

(A)

50 mg

Dosulepin Hydrochloride
MM 0510.00 Dosulepin Hydrochloride
N x HCl S

(A)

100 mg

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MM 0510.02

Imp. B (EP): Dibenzo[b,e]thiepin-11(6H)-one


O S

(A)

100 mg

MM 0510.08

Nordosulepin Hydrochloride

N H x HCl S

(A)

50 mg

Doxazosin Mesilate
MM 0386.00 Doxazosin Mesilate
N O O N N NH2 x N O S
O N O O N N NH2 N O O

O O O O OH

(A)

100 mg

MM 0386.08

Doxazosin

(A)

100 mg

MM 0386.04

Imp. A (EP): (2RS)-2,3-Dihydro-1,4-benzodioxine-2carboxylic Acid

O HO O O

(A)

100 mg

MM 0386.05

Imp. B (EP) as Hydrochloride: 1-[(2RS)-2,3-Dihydro1,4-benzodioxin-2-ylcarbonyl]piperazine Hydrochloride


HN

O N O O x HCl

(A)

100 mg

MM 0386.06

Imp. C (EP): 1,4-Bis(2,3-dihydro-1,4-benzodioxin2-ylcarbonyl)piperazine


O

O O N O N O O

(A)

100 mg

MM 0085.07

Imp. D (EP): 6,7-Dimethoxyquinazoline-2,4(1H,3H)-dione

O O

H N

O NH

(C)

100 mg

MM 0085.06

Imp. E (EP): 2,4-Dichloro-6,7-dimethoxyquinazoline

O O

N N Cl

Cl

(A)

100 mg

MM 0386.01

Imp. F (EP): 2-Chloro-6,7-dimethoxyquinazolin-4-amine

O O

N N NH2

Cl

(A)

100 mg

MM 0386.12

Imp. F (EP) as Mesilate: 2-Chloro-6,7-dimethoxyquinazolin-4-amine Mesilate Imp. G (EP): 6,7-Dimethoxy-2-(piperazin-1-yl)quinazolin4-amine

O O

N N NH2

Cl x O S O OH

(A)

100 mg

MM 0085.01

NH O O N N NH2 N

(A)

100 mg

MM 0085.03

Imp. H (EP): 2,2'-(Piperazine1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine)


N O O N N NH2 N

NH2 N N O O

(D)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Doxepin Hydrochloride
MM 0032.00 Doxepin Hydrochloride
N x HCl O

(A)

500 mg

MM 0032.03

Imp. A (EP): Dibenzo[b,e]oxepin-11(6H)-one (Doxepinone)


O

(A)
O

100 mg

MM 0032.04

Imp. B (EP): (11RS)-11-[3-(Dimethylamino)propyl]-6,11-dihydrodibenzo[b,e]oxepin11-ol (Doxepinol)


O

N OH

(A)

50 mg

MM 0032.08

Imp. C (EP) as E/Z-Mixture: (E,Z)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine ((E,Z)-Desmethyldoxepin)


O

NH

(A)

50 mg

Doxycycline Hyclate
New MM 0276.00 Doxycycline Hyclate
OH O H OH O OH H OH N O NH2 OH

(A)

100 mg

x HCl x 1/2 C2H5OH x 1/2 H2O

Doxylamine Hydrogen Succinate


MM 0101.00 Doxylamine Hydrogen Succinate
N O N x O O OH OH

(A)

500 mg

MM 0101.02

Imp. B (EP) as Hydrochloride: (1RS)-1-Phenyl1-(pyridin-2-yl)ethanol Hydrochloride


N OH

(A)
x HCl

50 mg

MM 0101.03

Imp. C (EP) as Hydrogen Fumarate: N,NDimethyl-2-[(RS)-1-phenyl(pyridin-2-yl)methoxy]ethanamine Hydrogen Fumarate Imp. D (EP): Phenyl(pyridin-2-yl)methanone (2-Benzoylpyridine)

O x OH HO O

(A)

50 mg

MM 0101.04

(A)
N O

100 mg

MM 0101.05

Doxylamine N-Oxide Dihydrochloride


N O N O x 2 HCl

(A)

100 mg

MM 0101.08

N-Desmethyldoxylamine Hydrogen Succinate


N O H N x

O OH OH O

(A)

50 mg

Drofenine Hydrochloride
MM 0768.00 Drofenine Hydrochloride
O O x HCl N

(A)

500 mg

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Pharmaceutical impurities
Code Product Price Unit

MM 0768.01

Drofenine N-Oxide Hydrochloride


O O x HCl N O

(A)

100 mg

Droperidol
MM 0138.01 Imp. A (EP): 1-(1,2,3,6-Tetrahydropyridin4-yl)-1,3-dihydro-2H-benzimidazol-2-one
HN N O NH

(A)

50 mg

New MM 0138.03

Imp. C (EP): 1-[4-(4-Fluorophenyl)-4-oxobutyl]-4-(2-oxo-2,3-dihydro-1H-benzimidazol1-yl)pyridinium Chloride

ClN O
+

(A)

50 mg

N O NH

MM 0138.04

Imp. D (EP) as Hydrochloride: (1RS)1-[4-(4-Fluorophenyl)-4-oxobutyl]4-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)1,2,3,6-tetrahydro-pyridine 1-Oxide Hydrochloride

F O N O O N NH x HCl

(A)

100 mg

Dropropizine
MM 1017.00 Dropropizine
N N OH OH

(A)

500 mg

Duloxetine Hydrochloride
MM 1122.00 Duloxetine Hydrochloride
S O N H x HCl

(A)

100 mg

MM 0043.04

Imp. D (EP): Naphthalen-1-ol (1-Naphthol)


OH

(B)

100 mg

Dydrogesterone
New MM 0328.02 Imp. B (EP): Pregna-4,6-diene-3,20-dione (6-Progesterone)
O

(A)

100 mg

Ebastine
MM 0468.00 Ebastine
N O O

(A)

100 mg

MM 0490.02

Imp. A (EP): Diphenylmethanol (Benzhydrol)


OH

(B)

100 mg

MM 0468.03

Imp. B (EP): 1-[4-(1,1-Dimethylethyl)phenyl]ethanone

(A)

100 mg

MM 0468.04

Imp. C (EP) as Hydrochloride: 4-(Diphenylmethoxy)piperidine Hydrochloride


O

(A)
NH x HCl

100 mg

MM 0468.05

Imp. D (EP): 1-[4-(1,1-Dimethylethyl)phenyl]4-(4-hydroxypiperidin-1-yl)butan-1-one


N HO O

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

MM 0468.06

Imp. E (EP) as Hydrogen Fumarate: 1-[4-(1,1-Dimethylpropyl)phenyl]4-[4-(diphenylmethoxy)piperidin1-yl]butan-1-one Hydrogen Fumarate

(A)
N O x HO O O OH O

100 mg

Econazole Nitrate
MM 0524.00 Econazole Nitrate
Cl O Cl N N Cl

(A)
x HNO3

500 mg

MM 0281.01

Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2(1H-imidazol-1-yl)ethanol


Cl HO

Cl

(A)

100 mg

N N

MM 0524.02

Imp. B (EP) as Nitrate: (2RS)-2-[(4-Chlorobenzyl)oxy]2-(2,4-dichlorophenyl)ethanamine Nitrate


Cl O Cl

Cl

(D)

100 mg

x HNO3 NH2
Cl

MM 0524.03

Imp. C (EP) as Chloride: 1-(4-Chlorobenzyl)3-[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4dichlorophenyl)ethyl]imidazolium Chloride

(A)

100 mg

Cl O Cl N+ N Cl-

Cl

Emedastine Difumarate
MM 1277.02 Imp. B (EP): 2-Chloro-1-(2-ethoxyethyl)-1HBenzimidazole
O

(A)
N N Cl

100 mg

Enalapril Maleate
MM 0010.00 Enalapril Maleate
H N O O O O N O OH x O OH OH

(A)

100 mg

MM 0010.05

Imp. B (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)3-phenylpropyl]amino]propanoic Acid


O

H N O

O OH

(A)

100 mg

MM 0010.01

Imp. C (EP): (2S)-1-[(2S)-2-[[(1S)-1-Carboxy3-phenylpropyl]amino]propanoyl]pyrrolidine-2carboxylic Acid (Enalaprilat)


HO

H N O

O N

OH

(D)

100 mg

MM 0010.06

Imp. D (EP): Ethyl (2S)-2-[(3S,8aS)-3-Methyl-1,4-dioxooctahydropyrrolo[1,2-]pyrazin-2-yl]-4-phenylbutanoate (Enalapril diketopiperazine)


O

H O N O N O

(A)

100 mg

MM 0015.02

Imp. I (EP): 1H-Imidazole (Imidazole)

H N N

(B)

100 mg

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Code Product Price
H N O O O O x HCl

Unit

MM 0010.15

(2S)-2[[(1S)-1-(Ethoxycarbonyl)3-phenylpropyl]amino]propanoic Acid Ethyl Ester Hydrochloride

(A)

100 mg

Enilconazole
MM 0281.01 Imp. E (EP): (1RS)-1-(2,4-Dichlorophenyl)-2(1H-imidazol-1-yl)ethanol
Cl HO N N Cl

(A)

100 mg

Enrofloxacin
MM 0395.00 Enrofloxacin
N N F O O N OH

(A)

100 mg

MM 0018.01

Imp. A (EP): 7-Chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline3-carboxylic Acid

(A)
Cl F O O N OH

100 mg

MM 0018.06

Imp. B (EP) as Hydrochloride Monohydrate: Ciprofloxacin Hydrochloride Monohydrate

HN N F O O N OH x HCl x H 2O

(A)

500 mg

MM 0395.01

Imp. C (EP) as Hydrochloride: 1-Cyclopropyl-7-(4-ethylpiperazin-1-yl)-4oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride (Desfluoroenrofloxacin Hydrochloride) Imp. G (EP): 7-[(2-Aminoethyl)amino]-1cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline3-carboxylic Acid Enrofloxacin N-Oxide Hydrochloride

N N N OH O
H2N HN F O O N OH

(A)
x HCl

100 mg

MM 0018.04

(D)

50 mg

MM 0395.07

O N N F O O N OH x HCl

(A)

100 mg

Entacapone
MM 1221.02 Imp. A (EP): (2Z)-2-Cyano-3-(3,4-dihydroxy5-nitrophenyl)-N,N-diethylprop-2-enamide
HO HO NO2 O N N

(A)

50 mg

MM 1221.04

Imp. B (EP): Ethyl (2E)-2-Cyano-3-(3,4dihydroxy-5-nitrophenyl)prop-2-enoate

O O 2N HO OH O N

(A)

50 mg

MM 1221.01

Imp. C (EP): 3,4-Dihydroxy-5-nitrobenzaldehyde

O2 N HO OH

(A)

100 mg

MM 1221.05

Imp. D (EP): (2E)-2-Cyano-3-(3-ethoxy-4hydroxy-5-nitrophenyl)-N,N-diethylprop-2enamide

O O 2N HO O N N

(A)

50 mg

MM 1221.06

Imp. E (EP): 3,5-Dinitrobenzene-1,2-diol

O2 N HO OH

NO2

(A)

50 mg

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Pharmaceutical impurities
Code Product Price
O O 2N HO OH OH N O O 2N HO OH N N O O 2N HO OH O N

Unit

MM 1221.07

Imp. F (EP): (2E)-2-Cyano-3-(3,4-dihydroxy5-nitrophenyl)prop-2-enoic Acid

(A)

50 mg

MM 1221.03

Imp. H (EP): (2E)-3-(3,4-Dihydroxy-5-nitrophenyl)-2-(piperidin-1-ylcarbonyl)prop-2ennitrile Imp. I (EP): Propyl (2E)-2-Cyano-3-(3,4dihydroxy-5-nitrophenyl)prop-2-enoate

(A)

50 mg

MM 1221.09

(A)

50 mg

Ephedrine Hydrochloride
MM 0652.00 Ephedrine Hydrochloride [Drug Precursor] Imp. B (EP) as Hydrochloride: Pseudoephedrine Hydrochloride [Drug Precursor] (1S,2R)-(+)-Ephedrine Hydrochloride [Drug Precursor] Methylephedrine (1R,2S)-Methylephedrine)
OH H N

(A)
x HCl

500 mg

MM 2115.00

OH

H N

(A)
x HCl

500 mg

MM 0652.03

OH

H N

(A)
x HCl

100 mg

New MM 0652.04

OH N

(A)

100 mg

Ephedrine Sulphate
MM 1147.00 Ephedrine Sulphate [Drug Precursor]
OH H N 2

(A)
x H2SO4

250 mg

Erdosteine
MM 0544.00 Erdosteine
S O N H O S O OH

(A)

100 mg

MM 0544.01

2-Chloro-N-(2-oxotetrahydrothiophen-3-yl)acetamide

O N H

O Cl

(A)

100 mg

Ergometrine Maleate
New MM 1385.00 Ergometrine Maleate [Drug Precursor]
H HN O O N H N x OH O OH OH

(A)

100 mg

Erythromycin
MM 0132.13 Imp. B (EP): N-Demethylerythromycin A
HO OO OH NH OH OO O O OH HO O O

(D)

100 mg

MM 0132.10

Imp. E (EP): Erythromycin A Enol Ether


O HO OO OH N OH OO O O O OH

(A)

50 mg

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Pharmaceutical impurities
Code Product Price Unit

Esomeprazole Magnesium Trihydrate


MM 0095.03 Imp. A (EP): 5-Methoxy-1H-benzimidazole-2-thiol
O N NH SH

(A)

100 mg

MM 0095.04

Imp. B (EP): 2-[(RS)-[(3,5-Dimethylpyridin2-yl)methyl]sulphinyl]-5-methoxy-1H-benzimidazole

O N

NH S O N

(A)

100 mg

MM 0095.06

Imp. C (EP): 5-Methoxy-2-[[(4-methoxy3,5-dimethylpyridin-2-yl)methyl]sulphanyl]-1H-benzimidazole (Ufiprazole) Imp. D (EP): 5-Methoxy-2-[[(4-methoxy3,5-dimethylpyridin-2-yl)methyl]sulphonyl]-1Hbenzimidazole (Omeprazole Sulphone) Imp. E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy-1Hbenzimidazol-2-yl)sulphinyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole N-Oxide)

O N

NH S N O

(A)

100 mg

MM 0095.05

O N

NH S O O O N

(A)

100 mg

MM 0095.07

O N

NH S O O N O

(A)

100 mg

Estazolam
New MM 1354.00 Estazolam [Controlled Substance]
N Cl N N N

(A)

100 mg

Estradiol Benzoate
MM 0301.00 Estradiol Benzoate
O O OH

(A)

500 mg

MM 0300.00

Imp. A (EP) as Hemihydrate: Estradiol Hemihydrate

OH x 1/2 H2O HO

(A)

500 mg

MM 0301.02

Imp. C (EP): Estra-1,3,5(10)-triene-3,17-diyl Dibenzoate (Estradiol 3,17-Dibenzoate)


O O

O O

(A)

100 mg

MM 0301.07

Imp. D (EP): 3-Hydroxyestra-1,3,5(10)-trien-17yl Benzoate (Estradiol 17-Benzoate)

O O

(A)

100 mg

HO

MM 0301.03

Imp. E (EP): 17-Hydroxyestra-1,3,5(10)-trien-3-yl Benzoate (17-epi-Estradiol Benzoate)


O O

OH

(C)

10 mg

MM 0301.08

Imp. G (EP): 17-Oxoestra-1,3,5(10)-trien-3-yl Benzoate (Estrone Benzoate)


O O

(A)

100 mg

MM 0278.01

Benzoic Acid

O OH

(B)

100 mg

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93

Pharmaceutical impurities
Code Product Price Unit

Estradiol Enanthate
MM 0473.00 Estradiol Enanthate
O O

(A)

100 mg

HO

Estradiol Hemihydrate
MM 0300.00 Estradiol Hemihydrate
OH
1

(A)
x /2 H2O

500 mg

HO

MM 0282.00

Imp. A (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone)


HO

(A)

500 mg

MM 0300.01

Imp. B (EP): Estra-1,3,5(10)-triene-3,17-diol (17-Estradiol; 17-epi-Estradiol)


HO

OH

(A)

100 mg

MM 0300.06

Imp. C (EP): 4-Methylestra-1,3,5(10)-triene-3,17-diol (4-Methylestradiol)


HO

OH

(A)

100 mg

MM 0300.02

Imp. D (EP): Estra-1,3,5(10),9(11)-tetraene-3,17-diol (9,11-Didehydroestradiol)


HO

OH

(D)

100 mg

New MM 0300.04

6alpha-Hydroxyestradiol

OH

(A)

100 mg

HO OH

MM 0300.03

6-Hydroxyestradiol
HO OH

OH

(D)

50 mg

MM 0300.08

6-Ketoestradiol

OH

(A)

100 mg

HO O

Estradiol Valerate
MM 0209.00 Estradiol Valerate
O O

(A)

500 mg

HO

MM 0300.00

Imp. A (EP) as Hemihydrate: Estradiol Hemihydrate

OH x 1/2 H2O HO

(A)

500 mg

MM 0209.06

Imp. B (EP): 17-Hydroxyestra-1,3,5(10)-trien-3-yl Pentanoate (Estradiol 3-Valerate)


O O

OH

(A)

100 mg

MM 0209.01

Imp. C (EP): 3-Hydroxyestra-1,3,5(10),9(11)-tetraen17-yl Pentanoate (9,11-Didehydroestradiol Valerate)

O O

(D)

100 mg

HO

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Pharmaceutical impurities
Code Product Price
O O

Unit

MM 0209.07

Imp. D (EP): 3-Hydroxy-4-methylestra-1,3,5(10)-trien17-yl Pentanoate (4-Methylestradiol Valerate)

(D)

100 mg

HO

MM 0209.02

Imp. E (EP): Estra-1,3,5(10)-trien-3,17-diyl Dipentanoate (Estradiol 3,17-Divalerate)


O O

O O

(A)

100 mg

MM 0209.04

Imp. F (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-yl Butanoate (Estradiol Butyrate)

O O

(A)

100 mg

HO

MM 0209.03

17-epi-Estradiol Valerate (17-Estradiol Valerate)


O

(D)

100 mg

HO

Estramustine Sodium Phosphate


MM 0100.01 Estramustine
O Cl Cl N O OH

(D)

100 mg

MM 0100.02

17-17'Bis3-{bis(2-chloroethyl)carbamoyloxy}estra-1,3,5(10)trienyl Pyrophosphate Disodium Salt

NaO O O ONa P P O O O

(D)

50 mg

O Cl Cl N O O

O N Cl Cl

Estriol
MM 0130.00 Estriol
OH OH HO

(A)

100 mg

MM 0130.06

Imp. A (EP): Estra-1,3,5(10),9(11)-tetraene-3,16,17-triol (9,11-Didehydroestriol)


HO

OH OH

(D)

100 mg

MM 0282.00

Imp. B (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone)


HO

(A)

500 mg

MM 0130.01

Imp. C (EP): 3-Methoxyestra-1,3,5(10)-triene-16,17-diol (Estriol 3-Methyl Ether)


O

OH OH

(D)

100 mg

MM 0300.00

Imp. D (EP) as Hemihydrate: Estradiol Hemihydrate


HO

OH
1

(A)
x /2 H2O

500 mg

MM 0130.05

Imp. E (EP): Estra-1,3,5(10)-triene-3,16,17-triol (17-epi-Estriol)


HO

OH OH

(D)

100 mg

MM 0130.04

Imp. F (EP): Estra-1,3,5(10)-triene-3,16,17-triol (16-epi-Estriol)


HO

OH OH

(D)

100 mg

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Pharmaceutical impurities
Code Product Price
OH OH HO

Unit

MM 0130.03

Imp. G (EP): Estra-1,3,5(10)-triene-3,16,17-triol (16,17-epi-Estriol)

(D)

100 mg

MM 0130.22

Imp. I (EP): 3-Hydroxy-17-oxa-D-homoestra-1,3,5(10)trien-17a-one


HO

O O

on request

MM 0130.02

6-Hydroxyestriol

OH OH HO OH

(D)

100 mg

MM 0130.14

Estriol 16,17-Diacetate

O O O O HO

(D)

100 mg

MM 0130.15

Estriol Triacetate
O O

O O O O

(D)

100 mg

MM 0130.16

Estriol 3-Benzyl Ether


O

OH OH

(D)

100 mg

MM 0130.17

16-Oxoestradiol

OH O

(D)

100 mg

HO

MM 0130.18

6-Oxoestriol

OH OH

(D)

100 mg

HO O

Estrogens conjugated
MM 0282.00 Imp. I (EP): 3-Hydroxyestra-1,3,5(10)-trien17-one (Estrone)
HO O

(A)

500 mg

Estrone
MM 0282.00 Estrone
O

(A)

500 mg

HO

MM 0282.01

Estrone 3-Methyl Ether

(A)

100 mg

Ethacridine Lactate Monohydrate


MM 0798.00 Ethacridine Lactate Monohydrate
H2N NH2 O N x OH O OH x H2O

(A)

250 mg

Ethinylestradiol
MM 0123.00 Ethinylestradiol
OH

(A)

500 mg

HO

MM 0123.02

Imp. B (EP): 19-Nor-17-pregna-1,3,5(10),9(11)-tetraen20-yne-3,17-diol (9,11-Didehydroethinylestradiol)


HO

OH

(D)

50 mg

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Pharmaceutical impurities
Code Product Price
O

Unit

MM 0282.00

Imp. C (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone)


HO

(A)

500 mg

MM 0300.00

Imp. D (EP) as Hemihydrate: Estradiol Hemihydrate


HO

OH
1

(A)
x /2 H2O

500 mg

MM 0123.07

Imp. E (EP): 19-Nor-17-pregna1,3,5(10)-trien-20-yne-3,6,17-triol (6-Hydroxyethinylestradiol)


HO OH

OH

(D)

100 mg

MM 0123.06

Imp. F (EP): 19-Nor-17-pregna1,3,5(10)-trien-20-yne-3,6,17-triol (6-Hydroxyethinylestradiol)


HO OH

OH

(D)

25 mg

MM 0123.05

Imp. G (EP): 3,17-Dihydroxy-19nor-17-pregna-1,3,5(10)-trien-20-yn-6-one (6-Oxoethinylestradiol, 6-Ketoethinylestradiol)


HO O

OH

(D)

100 mg

MM 0123.08

Imp. I (EP): 19-Nor-17-pregna1,3,5(10),6-tetraen-20-yne-3,17-diol (6,7-Didehydroethinylestradiol)


HO

OH

(D)

50 mg

MM 0300.01

Imp. L (EP): Estra-1,3,5(10)-triene3,17-diol (17-Estradiol; 17-epi-Estradiol)


HO

OH

(A)

100 mg

Ethionamide
MM 0845.00 Ethionamide
N S NH 2

(A)

250 mg

MM 0845.01

Ethionamide Sulphoxide
N

O S NH 2

(D)

100 mg

Ethosuximide
MM 0750.00 Ethosuximide
O H N O

(A)

500 mg

Ethyl Parahydroxybenzoate
MM 0498.00 Ethyl Parahydroxybenzoate
HO O O

(A)

500 mg

MM 0498.05

Sodium Ethyl Parahydroxybenzoate


NaO

O O

(A)

500 mg

MM 0045.01

Imp. A (EP): 4-Hydroxybenzoic Acid


HO

O OH

(B)

100 mg

MM 0431.00

Imp. B (EP): Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0432.00

Imp. C (EP): Propyl 4-Hydroxybenzoate (Propyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0496.00

Imp. D (EP): Butyl 4-Hydroxybenzoate (Butyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

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Pharmaceutical impurities
Code Product Price Unit

Ethylmorphine Hydrochloride
MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]
HO O
N x H2SO4 x 5 H2O HO O OH
N x H2O

N x HCl x 3 H2O

(A)

250 mg

OH

MM 0280.00

Imp. B (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]

(A)

250 mg

MM 0004.00

Imp. C (EP) as Monohydrate: Codeine Monohydrate [Controlled Substance]

(A)

100 mg

O N

OH

MM 0442.00

Imp. C (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]


O O

(A)
x H3PO4 x 1/2 H2O

100 mg

OH

Etilefrine Hydrochloride
MM 0035.00 Etilefrine Hydrochloride
OH HO H N

(A)
x HCl

500 mg

MM 0081.00

Imp. B (EP) as Hydrochloride: (1RS)1-(3-Hydroxyphenyl)-2-(methylamino)ethanol Hydrochloride (Phenylephrine Hydrochloride) Imp. C (EP) as Hydrochloride: (1RS)-2-Amino1-(3-hydroxyphenyl)ethanol Hydrochloride (Norfenefrine Hydrochloride) Imp. D (EP) as Hydrochloride: 2-(Benzylethyl-amino)1-(3-hydroxyphenyl)ethanone Hydrochloride (Benzyletilefrone Hydrochloride)

OH HO

H N

(A)
x HCl

500 mg

MM 0973.00

OH HO NH2 x HCl

(A)

500 mg

MM 0035.08

(A)
O HO N x HCl

100 mg

MM 0035.05

Imp. E (EP): 1-(3-Hydroxyphenyl)ethanone (3-Hydroxyacetophenone) Imp. F (EP): N-Benzylethanamine (Benzylethylamine)

O HO

(C)

100 mg

MM 0035.06

(C)
HN

100 mg

MM 0035.50

3-Benzoyloxyacetophenone
O O

(A)

100 mg

MM 0035.51

3-Benzoyloxy--bromoacetophenone
O

O O Br

on request

Etizolam
New MM 1386.00 Etizolam
S N N Cl N N

(A)

100 mg

Etodolac
MM 0911.00 Etodolac
H N O O OH

(A)

250 mg

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Pharmaceutical impurities
Code Product Price
O H N OH

Unit

MM 0911.01

Imp. A (EP): 2-[(1RS)-1-Ethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (8-Desethyl Etodolac) Imp. B (EP): 2-[(1RS)-1-Ethyl-8-methyl-1,3,4,9tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (8-Methyl Etodolac) Imp. C (EP): 2-[(1RS)-8-Ethyl-1-methyl-1,3,4,9tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (1-Methyl Etodolac) Imp. D (EP): 2-[(1RS)-1-Ethyl-8-(1-methylethyl)1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (8-Isopropyl Etodolac) Imp. F (EP): 2-[(1RS)-8-Ethyl-1-(1-methylethyl)1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (1-Isopropyl Etodolac) Imp. G (EP): 2-[(1RS)-8-Ethyl-1-propyl-1,3,4,9tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (1-Propyl Etodolac)

(A)

100 mg

MM 0911.02

O H N OH

(A)

100 mg

MM 0911.03

O H N OH

(A)

100 mg

MM 0911.04

O H N OH

(A)

50 mg

MM 0911.06

O H N OH

(A)

100 mg

MM 0911.07

O H N OH

(A)

100 mg

MM 0911.08

Imp. H (EP): 2-(7-Ethylindol-3-yl)ethanol

H N

OH

(A)

100 mg

MM 0911.10

Imp. J (EP): (1RS)-1,8-Diethyl-1-methyl-1,3,4,9tetrahydropyrano[3,4-b]indole (Decarboxy Etodolac Imp. K (EP): Methyl 2-[(1RS)-1,8-Diethyl-1,3,4,9tetrahydropyrano[3,4-b]indol-1-yl]acetate (Etodolac Methyl Ester)

(A)
H N O

100 mg

MM 0911.11

O H N O

(A)

100 mg

Etofenamate
MM 0410.00 Imp. A (EP): 2-[[3-(Trifluoromethyl)phenyl]amino]benzoic Acid (Flufenamic Acid)
O OH NH

(A)

500 mg

F F F

MM 0105.02

Imp. B (EP): Butyl 2-[[3-(Trifluoromethyl)phenyl]amino]benzoate (Butyl Flufenamate)

O O NH

(A)

100 mg

F F F

MM 0105.03

Imp. C (EP): N-Phenyl-3-(trifluoromethyl)aniline


NH

(A)

100 mg

F F F

MM 0105.04

Imp. D (EP): 2,2'-Oxybis(ethylene) Bis[2-[[3-(trifluoromethyl)phenyl]amino]benzoate]

O O NH O O

(A)

100 mg

HN

F F F

F F F

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Pharmaceutical impurities
Code Product Price
O O NH O O

Unit

MM 0105.05

Imp. E (EP): 2-(2-Butoxyethoxy)ethyl 2-[[3(Trifluoromethyl)phenyl]amino]benzoate

(A)

100 mg

F F F
HO O OH

MM 0105.06 MM 0105.07

Imp. F (EP): 2,2'-Oxydiethanol Imp. G (EP): 2-Hydroxyethyl 2-[[3-(Trifluoromethyl)phenyl]amino]benzoate

(A) (A)

100 mg 100 mg

O O NH OH

F F F

MM 0105.08

Etofenamate Myristate

O O NH O O

(A)

100 mg

F F F

MM 0105.09

Etofenamate Palmitate

O O NH O O

(A)

100 mg

F F F

MM 0105.10

Etofenamate Stearate

O O NH O O

(A)

100 mg

F F F

MM 0105.11

Triethylene Glycol Flufenamate

O O NH O O OH

(A)

100 mg

F F F

Etofylline
MM 0603.00 Etofylline
N O N O N N OH

(A)

500 mg

Etomidate
MM 1264.00 Etomidate
N N O O

(A)

100 mg

MM 1264.04

Imp. A (EP) as R-Enantiomer: 1-[(1R)-1Phenylethyl]-1H-imidazole-5-carboxylic Acid (Etomidate Acid)

N N O OH

(A)

50 mg

100

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Pharmaceutical impurities
Code Product Price Unit

Famciclovir
MM 0620.01 9-[4-Acetoxy-3-(acetoxymethyl)butyl]-2-amino6-chloropurine
H2N Cl N N N N O O O O

(A)

100 mg

Famotidine
MM 0029.00 Famotidine
H2N N S NH2 N S NH2 N S O O NH2

(A)

250 mg

MM 0029.06

Imp. A (EP) as Hydrochloride: 3-[[[2[(Diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanimidamide Hydrochloride Imp. B (EP) as Dimaleate: 3,5-Bis[2-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]ethyl]-4H1,2,4,6-thiatriazine 1,1-Dioxide Dimaleate

NH2 H2 N N N S S

NH NH2 x HCl

(A)

100 mg

MM 0029.05

O H2N NH2 N N S S N

S N H

O N S O N N S OH OH O H2 N NH2

(D)

50 mg

x2

MM 0029.01

Imp. C (EP) as Hydrochloride: 3-[[[2-[(Diaminomethylene)amino]thiazol4-yl]methyl]sulphanyl]-N-sulphamoylpropanamide Hydrochloride Imp. D (EP): 3-[[[2-[(Diaminomethylene)amino] thiazol-4-yl]methyl]sulphanyl]propanamide Imp. E (EP): 2,2'-[Disulphanediylbis(methylenethiazole-4,2-diyl)]diguanidine Imp. F (EP): 3-[[[2-[(Diaminomethylene)amino] thiazol-4-yl]methyl]sulphanyl]propanoic Acid Imp. G (EP) as Maleate: N-Cyano3-[[[2-(diaminomethylene)amino]thiazol4-yl]methyl]sulphanyl]propanimidamide Maleate Famotidine Sulphoxide

NH 2 H 2N N S N S

N H x HCl

O O S NH 2

(A)

100 mg

MM 0029.02

NH 2 H 2N N S
NH2 N N S S S N S

O N S NH 2

(A)

100 mg

MM 0029.07 MM 0029.03

H2 N N

H2 N

NH2

(A) (A)

100 mg 100 mg

NH2 H2N N S N S

O OH

MM 0029.09

H2N

NH2 N N S S

NH N H

O N x O OH OH

(A)

100 mg

MM 0029.04

NH 2 H 2N N S N S O

NH 2 N S O O NH 2

(A)

100 mg

MM 0029.10

Imp. I (Pharmeuropa): 3-[[[2-[(Diaminomethylene)amino]thiazol-4-yl]methyl]sulfinyl]-N-sulfamoylpropanamide 2-[(Diaminomethylene)amino]-4-(4-cyanobutyl) thiazole Hydrochloride

NH2 H2N N S
N N H2 N NH2 S

O N S O

N H

O O S NH2

(D)

50 mg

MM 0029.51

N x HCl

on request

Felodipine
MM 0139.00 Felodipine
O O O Cl Cl H N O

(A)

100 mg

MM 0139.01

Imp. A (EP): Ethyl Methyl 4-(2,3-Dichlorophenyl)2,6-dimethylpyridine-3,5-dicarboxylate

N O O O Cl Cl O

(D)

50 mg

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101

Pharmaceutical impurities
Code Product Price
H N O O O Cl Cl O

Unit

MM 0139.02

Imp. B (EP): Dimethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl1,4-dihydropyridine-3,5-dicarboxylate

(A)

100 mg

MM 0139.03

Imp. C (EP): Diethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl1,4-dihydropyridine-3,5-dicarboxylate

H N O O O Cl Cl O

(A)

100 mg

Fenbendazole
MM 2500.00 Imp. A (EP): Methyl (1H-Benzimidazol-2-yl)carbamate (Carbendazim) Fenbendazole Sulphoxide (Oxfendazole)
S O

H N N

O O NH
O O NH

(A)

100 mg

MM 0518.01

H N N

(A)

100 mg

MM 0518.02

Fenbendazole Sulphone
S O O

H N N

O O NH

(A)

100 mg

Fenbufen
MM 0918.00 Fenbufen
O OH O

(A)

500 mg

MM 0918.03

Imp. C (EP): Biphenyl

(A)

100 mg

MM 0918.05

4-(4-Chlorophenyl)-4-oxobutanoic Acid (3-(4-Chlorobenzoyl)propionic Acid)


Cl

O OH O

(A)

100 mg

Fencamfamine Hydrochloride
New MM 0995.01 Camfetamine Hydrochloride (N-Methyl-3phenylnorbornan-2-amine Hydrochloride)
HN

(A)
x HCl

100 mg

Fenfluramine Hydrochloride
MM 0608.00 Fenfluramine Hydrochloride
F F F
NH 2 x HCl F F F

H N x HCl

(A)

500 mg

MM 0608.01

Norfenfluramine Hydrochloride

(A)

100 mg

MM 0608.02

N-Nitrosofenfluramine

N N

(A)

100 mg

F F F

Fenofibrate
MM 0505.00 Fenofibrate
O Cl O O

(A)

500 mg

MM 0505.01

Imp. A (EP): (4-Chlorophenyl)(4-hydroxyphenyl)methanone

Cl

OH

(C)

100 mg

102

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Pharmaceutical impurities
Code Product Price
O Cl O

Unit

MM 0505.03

Imp. C (EP): (3RS)-3-[4-(4-Chlorobenzoyl)phenoxy]butan-2-one

(A)

100 mg

MM 0505.04

Imp. D (EP): Methyl 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoate

O Cl O O

(A)

100 mg

MM 0505.05

Imp. E (EP): Ethyl 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoate

O Cl O O

(A)

100 mg

MM 0505.06

Imp. F (EP): (4-Chlorophenyl)[4-(1-methylethoxy)phenyl]methanone Imp. G (EP): 1-Methylethyl 2-[[2-[4-(4-Chlorobenzoyl)phenoxy]-2methylpropanoyl]oxy]-2-methylpropanoate

Cl

(A)

100 mg

MM 0505.07

O Cl O O O O O

(A)

50 mg

Fenoprofen Calcium
MM 0790.00 Fenoprofen Calcium Dihydrate
O O O2 Ca 2+ x 2 H 2O

(A)

500 mg

Fentanyl
MM 0528.00 Fentanyl [Controlled Substance]
O N N

(A)

100 mg

MM 0528.09

Imp. A (EP) as Hydrochloride: N-Phenyl-N[cis,trans-1-oxido-1-(2-phenylethyl)piperidin4-yl]propanamide Hydrochloride (Fentanyl N-Oxide Hydrochloride)

O O N N x HCl

(A)

100 mg

MM 0528.08

Imp. B (EP): N-Phenyl-N-(piperidin-4-yl)propanamide

O N

NH

(A)

100 mg

MM 0528.03

Imp. C (EP): N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]acetamide

(A)
O N N

100 mg

MM 0528.04

Imp. D (EP): N-phenyl-1-(2-phenylethyl)piperidin-4-amine


N HN

(A)

100 mg

MM 0093.17 MM 0528.07

Imp. F (EP) as Hydrochloride: Aniline Hydrochloride (Phenylamine Hydrochloride) Imp. G (EP): N-Phenylpropanamide

NH2 x HCl

(B) (A)

100 mg 100 mg

O NH

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103

Pharmaceutical impurities
Code Product Price Unit

Fexofenadine Hydrochloride
MM 0507.01 Imp. A (EP): 2-[4-[4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl]phenyl]2-methylpropanoic Acid (Ketofexofenadine) (A)
OH O N O OH

100 mg

MM 0507.03

Imp. C (EP): (1RS)-4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)phenyl]butan-1-ol

(A)
OH OH N

100 mg

MM 0055.02

Imp. E (EP): Diphenyl(piperidin-4-yl)methanol


OH

(B)

100 mg

NH

Finasteride
MM 0415.00 Finasteride
O H N

(A)

100 mg

N H

MM 0415.01

Imp. A (EP): N-(1,1-Dimethylethyl)-3-oxo4-aza-5-androstane-17-carboxamide (Dihydrofinasteride)


O N H H

H N

(A)

100 mg

MM 0415.02

Imp. B (EP): Methyl 3-Oxo-4-aza-5-androst1-ene-17-carboxylate (-1-Aza Ester)

(A)

100 mg

N H H

MM 0415.04

3-Oxo-4-aza-5alpha-androstane-17beta-carboxylic Acid

OH

(A)

100 mg

N H H

Flavoxate Hydrochloride
MM 0156.00 Flavoxate Hydrochloride
O x HCl O O O N O

(A)

100 mg

MM 0156.01

Imp. A (EP): 3-Methyl-4-oxo-2-phenyl-4H-1benzopyran-8-carboxylic Acid (3-Methyl-flavone-8-carboxylic Acid) Imp. B (EP): Ethyl 3-Methyl-4-oxo-2-phenyl4H-1-benzopyran-8-carboxylate (3-Methylflavone-8-carboxylic Acid Ethyl Ester)
O

(A)

100 mg

O O OH

MM 0156.02

(A)

100 mg

O O O

MM 0156.05

Imp. C (EP): 1-Methylethyl-3-Methyl-4-oxo2-phenyl-4H-1-benzopyran-8-carboxylate (3-Methylflavone-8-carboxylic Acid Isopropyl Ester)

(A)

50 mg

O O O

104

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Pharmaceutical impurities
Code Product Price Unit

Flecainide Acetate
MM 0488.02 MM 0488.04 Imp. B (EP): (RS)-(Piperidin-2-yl)methanamine Imp. D (EP): 2,5-Bis(2,2,2-trifluoroethoxy) benzoic Acid
F F F O O F

H2N HN
O OH F F

(A) (A)

100 mg 100 mg

Fluanisone
MM 1247.02 1-(2-Methoxyphenyl)piperazine Dihydrochloride
N HN O x 2 HCl

(A)

100 mg

Flubendazole
MM 0463.00 Flubendazole
F H N N O O O NH

(A)

100 mg

MM 0463.02

Imp. B (EP): (2-Amino-1H-benzimidazol5-yl)(4-fluorophenyl)methanone Imp. C (EP): (4-Fluorophenyl)(2-hydroxy-1Hbenzimidazol-5-yl)methanone Imp. D (EP): (1H-Benzimidazol-5-yl)(4-fluorophenyl) methanone Imp. E (EP): Methyl [5-(2-Fluorobenzoyl)-1Hbenzimidazol-2-yl]carbamate

H N N O NH2

(A)

100 mg

MM 0463.03

H N OH N O

(C)

50 mg

MM 0463.04

H N N O

on request

MM 0463.05

H N N F O

O O NH

(C)

50 mg

MM 0463.06

Imp. F (EP): Methyl [5-(4-Fluorobenzoyl)-1-methyl-1Hbenzimidazol-2-yl]carbamate Imp. G (EP): Methyl [5-[4-(1-Methylethoxy)benzoyl]-1Hbenzimidazol-2-yl]carbamate

O N NH N O O

(C)

50 mg

MM 0463.07

H N N O

O O NH

(D)

100 mg

Flucloxacillin Sodium
MM 0489.00 Flucloxacillin Sodium Hydrate
Cl O N O O F H N N S H O F H N O O HN S ONa
O F HN NH S O O O H2 N N H Cl N O O F OH S OH OH

ONa x H 2O

(A)

500 mg

MM 0489.01

Imp. A (EP) as Disodium Salt: (4S)-2-[Carboxy[[[3-(2-chloro6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]methyl]5,5-dimethylthiazolidine-4-carboxylic Acid Disodium Salt (Penicilloic Acids of Flucloxacillin Disodium Salt) Imp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)5-methylisoxazol-4-yl]carbonyl]amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Flucloxacillin) Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) Imp. D (EP): 3-(2-Chloro-6-fluorophenyl)-5-methylisoxazole4-carboxylic Acid

Cl N O

ONa

(A)

100 mg

MM 0489.02

Cl N O

(A)

50 mg

MM 0026.04

(B)

100 mg

MM 0489.03

(C)

100 mg

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105

Pharmaceutical impurities
Code Product Price Unit

Fluconazole
MM 0235.00 Fluconazole
N N N N N N
F F HO N N N N

F F HO

(A)

100 mg

MM 0235.11

Imp. A (EP): (2RS)-2-(2,4-Difluorophenyl)-1(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol


N N

(A)

100 mg

MM 0235.12

Imp. B (EP): 2-[2-Fluoro-4-(1H-1,2,4-triazol-1yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol


N N N N N F HO

N N

(D)

100 mg

MM 0235.13

Imp. C (EP): 1,1'-(1,3-Phenylene)di-1H-1,2,4-triazole


N N N

N N

(A)

50 mg

MM 0235.14

Imp. D (EP): 2-(4-Fluorophenyl)-1,3-bis(1H1,2,4-triazol-1-yl)propan-2-ol


N N N N N HO

(A)

100 mg

MM 0235.02

Imp. F (EP): (2RS)-2-(2,4-Difluorophenyl)-3(1H-1,2,4-triazol-1-yl)propane-1,2-diol


N N N

F F HO

(A)

50 mg

OH

MM 0235.07

Imp. H (EP): (2RS)-1-Bromo-2-(2,4-difluorophenyl)3-(1H-1,2,4-triazol-1-yl)propan-2-ol


N N N

F F HO

(A)

50 mg

Br

MM 0235.01

2-(2,4-Difluorophenyl)propane-1,2,3-triol
F HO HO OH

(A)

100 mg

MM 0235.03 MM 0235.04

1H-1,2,4-Triazol
N

H N

(B)
N
F

100 mg 100 mg

2-Chloro-2',4'-difluoroacetophenone
F O

(C)

Cl

MM 0235.06

1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanol
F HO N

(A)

100 mg

N N
N N H2N N

MM 0235.09

4-Amino-1,2,4-triazole

(C)

100 mg

106

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Pharmaceutical impurities
Code Product Price Unit

Flucytosine
MM 0593.00 Imp. A (EP): 5-Fluoropyrimidine-2,4(1H,3H)-dione (Fluorouracil)
O HN O N H F

(A)

500 mg

Flufenamic Acid
MM 0410.00 Flufenamic Acid
O OH NH

(A)

500 mg

F F F

Flumetasone Pivalate
MM 0427.01 Imp. A (EP): 6,9-Difluoro-11,17,21-trihydroxy-16methylpregna-1,4-diene-3,20-dione (Flumetasone)
O HO OH OH

(A)

100 mg

F O F

Flunarizine Dihydrochloride
MM 0175.00 Flunarizine Dihydrochloride
F N x 2 HCl N

(A)

500 mg

MM 0175.04

Imp. A (EP): 1-[Bis(4-fluorophenyl)methyl]piperazine

F N

NH

(A)

100 mg

MM 0175.03

Imp. C (EP) as Dihydrochloride: 1-[(RS)-(2-Fluorophenyl)(4-fluorophenyl)methyl]-4-[(2E)-3-phenylprop2-enyl]piperazine Dihydrochloride Chlorobis-(4-fluorophenyl)methane

F N F

N x 2 HCl

(A)

100 mg

MM 0175.02

Cl

(B)
F

100 mg

MM 0175.05

1-Bis(4-fluorophenyl)methyl-4-(ethoxycarbonyl)piperazine

O N N

(B)

10 mg

MM 0175.06

Flunarizine N-Oxide Dihydrochloride

F N

O N

(A)

100 mg

x 2 HCl

Flunitrazepam
MM 0069.00 Flunitrazepam [Controlled Substance]
O2N N N F O

(A)

100mg

MM 0069.02

Imp. B (EP): 5-(2-Fluorophenyl)-7-nitro-1,3-dihydro-2H1,4-benzodiazepin-2-one (Demethylflunitrazepam)


O2N

H N N

(A)

100 mg

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107

Pharmaceutical impurities
Code Product Price Unit

Flunixin Meglumine
MM 0915.00 Flunixin Meglumine
F OH N NH OH O x HO HO OH F F H N OH

(A)

100 mg

MM 0915.01

Imp. A (EP): 2-Chloropyridine-3-carboxylic Acid

Cl OH O

(A)

100 mg

MM 0915.03

Imp. C (EP): Ethyl 2-Chloropyridine-3-carboxylate

Cl O O

(A)

100 mg

Fluorescein Sodium
MM 0294.01 MM 0133.04 Imp. A (EP): Resorcinol
HO OH

(B) (A)
OH O HO OH O

100 mg 100 mg

Imp. C (EP): 2-(2,4-Dihydroxybenzoyl)benzoic Acid

Fluorouracil
MM 0593.00 Fluorouracil
HN O N H O F

(A)

500 mg

MM 0265.03

Imp. A (EP): Pyrimidine-2,4,6-(1H,3H,5H)trione (Barbituric Acid)

O HN O N H
O HN O N H O

(C)
O

100 mg

MM 0593.01

Imp. B (EP): Dihydropyrimidine-2,4,5(3H)trione (Isobarbituric Acid or 5-Hydroxyuracil)

(A)

100 mg

MM 0593.03

Imp. C (EP): Pyrimidine-2,4(1H,3H)-dione (Uracil)


HN O

(C)

100 mg

N H
O Cl N H O F N H

MM 0593.05

Imp. E (EP): 5-Chloropyrimidine-2,4(1H,3H)dione (5-Chlorouracil)

(A)

100 mg

HN O

MM 0593.06

Imp. F (EP): 2-Ethoxy-5-fluoropyrimidin4(1H)-one (2-Ethoxy-5-fluorouracil)


O

(A)

100 mg

Fluoxetine Hydrochloride
MM 0256.00 Fluoxetine Hydrochloride
F F F
H N

H N x HCl

(A)

50 mg

MM 0256.01

Imp. A (EP): (1RS)-3-(Methylamino)-1-phenylpropan-1-ol

HO

(A)

100 mg

MM 0256.02

Imp. B (EP) as Hydrochloride: N-Methyl-3phenylpropan-1-amine Hydrochloride (Methyl-3-phenylpropylamine Hydrochloride) [Controlled Substance] Imp. C (EP) as Hydrochloride:(3RS)-N-Methyl-3phenyl-3-[3-(trifluoromethyl]phenoxy]propan-1-amine Hydrochloride
O H N

H N x HCl

(A)

100 mg

MM 0256.03

(A)
x HCl

100 mg

F F F

108

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Pharmaceutical impurities
Code Product Price
OH F F F Cl F F F
OH N

Unit

MM 0256.05

4-Hydroxybenzotrifluoride

(B)

100 mg

MM 0256.06

4-Chlorobenzotrifluoride

(B)

100 mg

MM 0256.10

3-Dimethylamino-1-phenylpropan-1-ol

(A)

100 mg

MM 0256.16

N-Formylfluoxetine
O F F F
F F O H N

O N

(A)

100 mg

MM 256.17

(3RS)-N-Methyl-3-phenyl-3-[2-(trifluoromethyl)phenoxy]propan-1-amine Hydrochloride (2-Trifluoromethylisomer of Fluoxetine Hydro-chloride)

(A)

100 mg

x HCl

New MM 0256.18

Norfluoxetine Oxalate
F F F

NH2 x

HO HO

O O

(A)

100 mg

Fluoxymesterone
MM 0959.00 Fluoxymesterone
OH HO

(A)

100 mg

F O

Flupentixol Decanoate
MM 0182.08 Imp. B (BP): 2-Trifluoromethylthioxanthone
O CF3 S

(A)

100 mg

MM 0182.05 MM 0182.06

1-(2-Hydroxyethyl)piperazine cis/trans-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene

HN N

OH

(B)

100 mg on request

CF3 S

MM 0182.07 MM 0182.09

4-Chloro-3-nitrobenzotrifluoride 4-Fluoro-3-nitrobenzotrifluoride

O2N Cl O2 N F

CF3

(B) (B)

100 mg 100 mg

CF3

Flupentixol Dihydrochloride
MM 0182.08 Imp. G (EP): 2-(Trifluoromethyl)-9H-thioxanthen-9-one (2-Trifluoromethylthioxanthone) 1-(2-Hydroxyethyl)piperazine cis/trans-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene
CF3 S HN N O CF3 S

(A)

100 mg

MM 0182.05 MM 0182.06

OH

(B)

100 mg on request

MM 0182.07 MM 0223.06

4-Chloro-3-nitrobenzotrifluoride Flupentixol Dihydrochloride


N S F F F

O 2N Cl

CF3

(B) (A)

100 mg 100 mg

OH

x 2 HCl

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Pharmaceutical impurities
Code Product Price Unit

Fluphenazine Dihydrochloride
MM 0114.00 Fluphenazine Dihydrochloride
N S F F F N N OH x 2 HCl

(A)

500 mg

MM 0114.01

Imp. A (EP): 2-[4-[3-[5-Oxo-2-(trifluoromethyl)410H-5 phenothiazin-10-yl]propyl]piperazin-1yl]ethanol (Fluphenazine S-Oxide)

(A)
N O S F F F
F F S N N S F F F N N F

100 mg

N N OH

MM 0114.07

Imp. D (EP): 10,10'-[Piperazine-1,4-diylbis(propane3,1-diyl)]bis[2-(trifluoromethyl)-10H-phenothiazine]

(A)

100 mg

MM0826.00

Imp. E (EP): 2-[4-[3-[2-Chloro-10H-phenothiazin10-yl]propyl]piperazin-1-yl]ethanol (Perphenazine)


S

(A)
N N N Cl OH

100 mg

MM 0114.04

Fluphenazine N,N',S-Trioxide Dihydrochloride


N O S F F F

O N N O OH x 2 HCl

(A)

100 mg

Flurazepam Monohydrochloride
MM 0070.01 Imp. A (EP): [5-Chloro-2-[[2-(diethylamino)ethyl]amino] phenyl]-(2-fluorophenyl)methanone
Cl H N O F N

on request

MM 0070.02

Imp. B (EP): 7-Chloro-5-(2-fluorophenyl)-1,3-dihydro2H-1,4-benzodiazepin-2-one


Cl

H N N

(A)

100 mg

MM 0070.03

2-Chloro-10-(2-diethylaminoethyl)-9,10-dihydroacridin-9-one
N Cl O

(A)

100 mg

MM 0070.06

Flurazepam [Controlled Substance]

N O

(A)

100 mg

N Cl N

New MM 0070.07

2-Hydroxyethylflurazepam

HO O

(A)

50 mg

N Cl N

110

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Pharmaceutical impurities
Code Product Price Unit

Flurbiprofen
MM 0727.01 Imp. A (EP): (2RS)-2-(Biphenyl-4-yl)propanoic Acid
OH O

(A)

50 mg

MM 0727.03

Imp. C (EP): (2RS)-2-(2-Fluorobiphenyl-4-yl)2-hydroxypropanoic Acid

HO F O OH

(A)

50 mg

Flutamide
MM 0161.00 Flutamide
O H N F F F NO2

(A)

500 mg

MM 0161.03

Imp. A (EP): 4-Nitro-3-(trifluoromethyl)aniline

F H2N

F F NO2

(A)

100 mg

MM 0161.04

Imp. B (EP): N-[4-Nitro-3-(trifluoromethyl)phenyl]acetamide


O

H N

F F NO2

(A)

100 mg

MM 0161.05

Imp. C (EP): N-[4-Nitro-3-(trifluoromethyl)phenyl]propanamide


O

H N

F F NO2

(A)

100 mg

MM 0161.06

Imp. D (EP): 3-(Trifluoromethyl)aniline

F H2N

F F

(B)

100 mg

MM 0161.07

Imp. E (EP): 2-Methyl-N-[3-(trifluoromethyl)phenyl]propanamide


O

H N

F F

(A)

100 mg

MM 0161.08

Imp. F (EP): 2-Methyl-N-[2-nitro5-(trifluoromethyl)phenyl]propanamide 2-Hydroxy-2-methyl-N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide (2-Hydroxyflutamide) Trifluoromethylbenzene


HO

H N O O2N

F F

(D)

100 mg

MM 0161.01

H N O

F F NO2

(A)

100 mg

MM 0161.09

F F

(B)

100 mg

MM 0161.10

3-Nitrobenzotrifluoride

F O2 N

F F

(B)

100 mg

MM 0161.12

3-Trifluoromethyl-4-nitrophenol

F HO

F F NO2

(A)

100 mg

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111

Pharmaceutical impurities
Code Product Price Unit

Fluticasone Propionate
MM 1244.10 6,9-Difluoro-11,17-dihydroxy-16-methyl3-oxoandrosta-1,4-diene-17-carboxylic Acid
O HO OH OH

(A)

100 mg

F O F

Fluvastatin Sodium
MM 0676.00 Fluvastatin Sodium
F

(D)

100 mg

OH N OH O ONa

Folic Acid
MM 0621.00 Folic Acid
O N H2N N H N N O N H H2N O N H O O N H O OH

(A)
OH

500 mg

MM 0621.01

Imp. A (EP): (2S)-2-[(4-Aminobenzoyl)amino] pentanedioic Acid (N-(4-Aminobenzoyl)-L-glutamic Acid)

OH

(A)
OH

100 mg

MM 0621.02

Imp. B (EP) as Sulphate: 2,5,6-Triaminopyrimidin4(1H)-one Sulphate


H2N

O N N H NH2 NH2

(A)
x H2 SO4

100 mg

MM 0621.04

Imp. D (EP): 4-[[(2-Amino-4-oxo-1,4-dihydropteridin6-yl)methyl]amino]benzoic Acid (Pteroic Acid)


N H2N

O O N N H N
O OH H2N

(D)
OH

50 mg

N H

MM 0094.03

4-Aminobenzoic Acid

(B)

100 mg

MM 0169.00 New MM 0621.09

L-Glutamine 6-Formylpterin

NH2 H2N O O OH

(A) (D)

500 mg 50 mg

O N H2N N H N N

Formoterol Fumarate Dihydrate


MM 0447.00 Formoterol Fumarate Dihydrate
HO HN O and enantiomer O x HO O OH x 2 H2O OH H N O 2

(D)

50 mg

New MM 0447.07

Imp. G (EP) as Hydrochloride: (2RS)-1(4-Methoxy-phenyl)propan-2-amine Hydrochloride [Controlled Substance]

H2N x HCl O

(A)

100 mg

Fumaric Acid
New MM 0352.03 Monomethyl Fumarate
O O

(A)

100 mg

O HO

112

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Pharmaceutical impurities
Code Product Price Unit

Furosemide
MM 0014.00 Furosemide
H 2N O O OH H N S O Cl O

(A)

500 mg

MM 0014.02

Imp. A (EP): 2-Chloro-4-[(furan-2-ylmethyl)amino]5-sulphamoylbenzoic Acid


H2N O S

OH Cl

(A)

100 mg

HN
O

O
OH Cl

MM 0014.03

Imp. B (EP): 2,4-Dichloro-5-sulphamoylbenzoic Acid


H 2N O S

(B)

100 mg

O O

Cl OH NH 2

MM 0014.01

Imp. C (EP): 2-Amino-4-chloro-5-sulphamoylbenzoic Acid


H 2N O S

(A)

100 mg

Cl

MM 0014.04

Imp. D (EP): 2,4-Bis[(furan-2-ylmethyl)amino]5-sulphamoylbenzoic Acid


H2N O S

OH H N O

(D)

100 mg

O HN

O
O OH Cl

MM 0014.05

Imp. E (EP): 2,4-Dichlorobenzoic Acid

(B)

100 mg

Cl

MM 0014.50

Ethyl 2,4-Dichloro-5-sulphamoylbenzoate
H2N O

O Cl

(A)

100 mg

S O Cl

Gabapentin
MM 0684.01 Imp. A (EP): 2-Azaspiro[4.5]decan-3-one (3,3-Pentamethylene-4-butyrolactam)
O HN

(A)

100 mg

MM 0684.07

Imp. E (EP): 1-(Carboxymethyl)cyclohexanecarboxylic Acid

O HO

O OH

(A)

100 mg

Ganciclovir
MM 0485.00 Ganciclovir
HN H2N N O N N O HO OH

(A)

100 mg

MM 0061.02

Imp. F (EP): 2-Amino-1,9-dihydro-6H-purin-6-one (Guanine)


HN H2N

O N N N H

(B)

100 mg

New MM 0485.08

Imp. H (EP): 2-Amino-7-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-1,7-dihydro-6H-purin-6one (N-7 Isomer of Ganciclovir)


H2N

HO O HN N N N O OH

(A)

50 mg

MM 0485.09

Imp. I (EP): 2-[(2-Amino-6-oxo-1,6-dihydro9H-purin-9-yl)methoxy]propane-1,3-diyl Dipropanoate (Ganciclovir Dipropionate)

O HN H2N N N N O O O O O

(A)

100 mg

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113

Pharmaceutical impurities
Code Product Price
O O HN N H N N N O O O O O

Unit

MM 0485.10

Imp. J (EP): 2-[2-(Propanoylamino)-6-oxo1,6-dihydro-9H-purin-9-yl]methoxy] propane-1,3-diyl dipropanoate (Ganciclovir Tripropionate)

(A)

100 mg

Gemcitabine Hydrochloride
MM 1257.00 Gemcitabine Hydrochloride
N HO O O F OH F N x HCl NH2

(A)

100 mg

MM 0749.05

Imp. A (EP): 4-Aminopyrimidin-2(1H)-one (Cytosine)


O

NH2 N N H

(A)

100 mg

Gemfibrozil
MM 0641.00 Gemfibrozil
O O OH

(A)

250 mg

MM 0641.08 MM 0641.07

Imp. A (EP): 2,5-Dimethylphenol (p-Xylenol) Imp. E (EP): 5-[2,5-Dimethyl-4-(prop-1-enyl)phenoxy]-2,2-dimethylpentanoic Acid Imp. H (EP): 1,3-Bis(2,5-dimethylphenoxy)propane 3-(2,5-Dimethylphenoxy)propyl Chloride (3-(2,5-Xylyloxy)propyl Chloride) Gemfibrozil Isobutyl Ester

OH

(A) (D)

100 mg 100 mg

O O

OH

MM 0641.02 MM 0641.01 MM 0641.03

(A)
Cl

100 mg 100 mg 100 mg

(A) (A)

Gestodene
MM 0124.06 Imp. L (EP): 13-Ethyl-17-hydroxy-18,19dinor-17-pregna-5,15-dien-20-yn-3-one (56)-Gestodene)
O OH

(A)

100 mg

GHB Sodium Salt


MM 1355.00 GHB Sodium Salt (Sodium Gammahydroxybutyrate) [Controlled Substance]
O HO ONa

(A)

100 mg

Glibenclamide
MM 0008.00 Glibenclamide
O Cl O N H

(A)

500 mg

MM 0008.01

Imp. A (EP): 5-Chloro-2-methoxy-N(2-(4-sulfamoylphenyl)ethyl)benzamide

(A)
O Cl O N H

100 mg

MM 0008.02

Imp. B (EP): Methyl [[4-[2-[(5-Chloro2-methoxybenzoyl)amino]ethyl]phenyl]-sulphonyl]carbamate


Cl

(A)
O N H O

100 mg

114

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Pharmaceutical impurities
Code Product Price Unit

MM 0942.09

Imp. C (Pharmeuropa): 1-[[4-[2-[(Cyclohexylcarbamoyl)amino]ethyl]phenyl]sulfonyl]-3-cyclohexylurea (N-(Cyclohexylcarbamoyl)-4-[2-[(cyclohexylcarbamoyl)amino]ethyl] benzene-Sulphonamide) Imp. D (Pharmeuropa): 1-[[4-[2-[(5-Chloro2-methoxybenzoyl)amino]ethyl]phenyl]-sulfonyl]-3-butylurea


Cl

(A)
O N H N H

100 mg

MM 0008.07

(A)
O N H O

50 mg

New MM 0008.08

Imp. E (Pharmeuropa): 1-[[4-[2-[(3,5-Di-chloro2-methoxybenzoyl)amino]ethyl]phenyl]sulfonyl]-3-cyclohexylurea

(A)
O Cl O Cl N H

50 mg

MM 0008.03

5-Chloro-2-methoxybenzoic Acid

O Cl O OH

(B)

100 mg

MM 0008.04

5-Chloro-N-(2-phenylethyl)-2-methoxybenzamide
Cl

O N H O

(A)

100 mg

Gliclazide
MM 0325.00 Gliclazide
O S O N H O N H N

(A)

500 mg

MM 0325.01

Imp. A (EP): 4-Methylbenzenesulphonamide

O S

O NH2

(C)

100 mg

MM 0325.02

Imp. B (EP): 2-Nitroso-octahydrocyclopenta[c]pyrrole


O N N

(A)

100 mg

MM 0325.03

Imp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]Carbamate

O O O S N O H

(A)

100 mg

MM 0325.06

Imp. F (EP): 1-(Hexahydrocyclopenta[c]pyrrol2(1H)-yl)-3-[(2-methylphenyl)sulphonyl]urea

O O O S N N N H H

(A)

100 mg

MM 0325.09

Methyl N-Methyl-p-tolylsulphoncarbamate

O O O S N O

(A)

100 mg

Glimepiride
MM 0647.00 Glimepiride
O O N N H O S

(D)

100 mg

MM 0647.02

Imp. A (EP): 1-[[4-[2-[[(3-Ethyl-4-methyl-2-oxo-2,3-dihydro-1H-pyrrol1-yl)carbonyl]-amino]ethyl]phenyl]sulphonyl]-3-(cis4-methylcyclohexyl)urea (cis-Glimepiride)

O S O O N N H

(D)

100 mg

MM 0647.01

Imp. B (EP): 3-Ethyl-4-methyl-2-oxo-N[2-(4-sulphamoylphenyl)ethyl]-2,3-dihydro-1Hpyrrole-1-carboxamide (Glimepiride Sulphonamide)

(A)
O N O N H

100 mg

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115

Pharmaceutical impurities
Code Product Price Unit

MM 0647.01

Imp. B (EP): 3-Ethyl-4-methyl-2-oxo-N[2-(4-sulphamoylphenyl)ethyl]-2,3-dihydro-1Hpyrrole-1-carboxamide (Glimepiride Sulphonamide)

(A)
O N O N H

100 mg

MM 0647.03

Imp. C (EP): Methyl [[4-[2-[[(3-Ethyl-4-methyl2-oxo-2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]phenyl]sulphonyl]carbamate (Glimepiride Carbamate)

(A)
O N O N H

100 mg

MM 0647.04

Imp. D (EP): 1-[[3-[2-[[(3-Ethyl-4-methyl-2-oxo2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]phenyl]sulphonyl]-3-(trans-4-methylcyclohexyl)urea


O

(D)

100 mg

N O

H N

MM 0647.08

cis-4-Methylcyclohexylamine Hydrochloride
H2N

x HCl

(A)

100 mg

Glipizide
MM 0942.01 Imp. A (EP): 5-Methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide
N N O N H O O S NH2

(A)

100 mg

MM 0678.03 MM 0942.04

Imp. B (EP): Cyclohexanamine


H2N

(C)
O O S NH2 N H

100 mg 100 mg

Imp. D (EP): 6-Methyl-N[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide


N N

(A)

MM 0942.05

Imp. E (EP): 1-Cyclohexyl-3-[[4-[2-[[(6-methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]sulphonyl]urea

O N N N H

O O O S N N H H

(A)

100 mg

MM 0942.06

Imp. F (EP): Ethyl [2-(4-Sulphamoylphenyl)ethyl]carbamate


O

O N H

O O S NH2

(A)

100 mg

MM 0942.07

Imp. G (EP): Methyl [[4-[2-[[(5-Methylpyrazin2-yl)carbonyl]amino]ethyl]phenyl]sulphonyl]carbamate Imp. H (EP): 4-[2-[(Cyclohexylcarbamoyl)amino]ethyl]benzenesulphonamide

O N N N H

O O O S N O H

(A)

100 mg

MM 0942.08

O N H N H

O O S NH2

(A)

100 mg

MM 0942.09

Imp. I (EP): N-(Cyclohexylcarbamoyl)4-[2-[(cyclohexylcarbamoyl)amino]ethyl]benzenesulphonamide

O N H N H

O O O S N N H H

(A)

100 mg

Glutamine
MM 0169.00 MM 0169.01 L-Glutamine N-Phenylacetyl-L-glutamine (Phenylacetylglutamine)
H2N O O NH2 O NH2 H2N O O HN OH O OH

(A) (A)

500 mg 100 mg

MM 0169.02

Phenylacetamide

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
NH2 H2N O O OH

Unit

MM 0169.03

D-Glutamine

(A)

100 mg

Glycopyrronium Bromide
MM 0834.00 Glycopyrronium Bromide
O O OH and enantiomer N+ Br-

(A)

100 mg

MM 0834.05

Imp. B (EP): Oxophenylacetic Acid (Benzoylformic Acid)


O

O OH

(A)

100 mg

MM0792.03

Imp. C (EP): (2RS)-2-Hydroxy-2-phenylacetic Acid (Mandelic Acid) Imp. D (EP): Benzoic Acid

O OH OH

(A)

100 mg

MM 0278.01

(B)
OH O

100 mg

MM 0834.07

Imp. H (EP): Methyl 2-oxo-2-Phenylacetate (Methyl Benzoylformate)


O

O O

(A)

100 mg

MM 0834.01

Imp. J (EP): 2-(RS)-Cyclopentyl-2-hydroxy2-phenylacetic Acid (-Cyclopentylmandelic Acid) Imp. K (EP): (2RS)-2-Cyclopentyl-2-phenylacetic Acid

O OH OH

(A)

100 mg

MM 0834.08

O OH

(A)

100 mg

MM 0834.06

Imp. M (EP): Cyclopentylphenylmethanone


O

(A)

100 mg

Granisetron Hydrochloride
New MM 0398.02 Imp. B (EP): N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide
H HN N H N O H
H H N O H
N N OH O

(A)
N

50 mg

New MM 0398.03

Imp. C (EP): N-[(1R,3r,5S)-9-Azabicyclo[3.3.1]non3-yl]-1-methyl-1H-indazole-3-carboxamide

N N

(A)
NH

50 mg

MM 0398.04

Imp. D (EP): 1-Methyl-1H-indazole-3-carboxylic Acid

(A)

100 mg

MM 0398.07

Imp. G (EP): 2-Methyl-2H-indazole-3-carboxylic Acid

N N OH O

(A)

100 mg

MM 0398.08

Imp. H (EP): 1H-Indazole-3-carboxylic Acid

HN N OH O

(A)

100 mg

New MM 0398.09

Imp. I (EP): 1-Methyl-1H-indazole-3-carboxylic Anhydride

N N O O O

N N

(A)

50 mg

Griseofulvin
MM 0582.00 Griseofulvin
O Cl O O O O O

(A)

500 mg

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117

Pharmaceutical impurities
Code Product Price Unit

Guaiacol
MM 0354.04 MM 0814.04 MM 0045.11 MM 0814.06 MM 0814.08 Guaiacol Imp. A (EP): Benzene-1,2-diol (Pyrocatechol) Imp. B (EP): Phenol Imp. C (EP): 1,2-Dimethoxybenzene (Veratrole) Imp. E (EP): Methyl Benzoate
O O

OH O
OH OH

(A) (C) (B) (C) (C)

500 mg 100 mg 100 mg 100 mg 100 mg

OH

O O

MM 1131.00 MM 0007.09

Imp. G (EP): 4-Methoxyphenol (Mequinol)


O

OH

(A) (B)

500 mg 100 mg

Imp. H (EP): 3-Methoxyphenol


O

OH

Guaifenesin
MM 0354.00 Guaifenesin
OH O O OH

(A)

500 mg

MM 0354.04 MM 0354.01

Imp. A (EP): 2-Methoxyphenol (Guaiacol) Imp. B (EP): 2-(2-Methoxyphenoxy)propane-1,3-diol (B-Isomer) Imp. C (EP): 1,1'-Oxybis[3-(2-methoxyphenoxy) propan-2-ol] (Bisether) Imp. D (EP): 1,3-Bis(2-methoxyphenoxy)propan-2-ol
OH O O O

OH O
HO O O OH

(A) (A)

500 mg 100 mg

MM 0354.02

OH O O

(A)

100 mg

MM 0354.03

OH O O O O

(A)

100 mg

Guanidine Thiocyanate
MM 1315.00 Guanidine Thiocyanate
H2N NH NH2 x HS N

(A)

100 mg

Haloperidol Decanoate
MM 1276.12 Imp. L (EP): 1-(4-Fluorophenyl)ethanone
F

(A)
O

100 mg

Harpagoside
MM 0370.01 Methyl trans-Cinnamate
O O

(B)

100 mg

Hexetidine
MM 0337.03 Imp. C (EP): 2,6-Bis(2-ethylhexyl)-7a-methylhexahydro-1Himidazo[1,5-c]imidazole (Hexedine) (A)
N N

100 mg

Hexylresorcinol
MM 0111.00 Hexylresorcinol
HO OH

(A)

500 mg

MM 0045.11

Imp. A (EP): Phenol

OH

(B)

100 mg

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Pharmaceutical impurities
Code Product Price
HO OH

Unit

MM 0294.01

Imp. B (EP): Resorcinol

(B)

100 mg

Homatropine Methylbromide
MM 0792.00 Homatropine Methylbromide
H O H O OH N
+

(A)
Br
-

250 mg

H and enantiomer
O OH OH

MM 0792.03

Imp. C (EP): (2RS)-2-Hydroxy-2-phenylacetic Acid (Mandelic Acid) Imp. D (EP) as Bromide: (1R,2R,4S,5S,7s)-7-[[(2S)3-Hydroxy-2-phenylpropanoyl]oxy]-9,9-dimethyl3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide (Methylhyoscine Bromide) Imp. F (EP): Methyl (2RS)-2-Hydroxy-2-phenylacetate (Methyl Mandelate)
H O H O OH H N
+

(A)

100 mg

MM 0792.04

H O H Br
-

(A)

100 mg

MM 0792.06

O O OH

(A)

100 mg

Hydrochlorothiazide
MM 0011.00 Hydrochlorothiazide
O H2N S Cl O O S N H
O S Cl O S N O S O NH2 O NH

O NH

(A)

500 mg

MM 0011.03

Imp. A (EP): Chlorothiazide

O H2N

(A)

500 mg

MM 0011.01

Imp. B (EP): 4-Amino-6-chlorobenzene-1,3-disulphonamide (Salamide)

O H2N S Cl

(B)

100 mg

NH2

Hydrocodone Hydrogen Tartrate 2.5-Hydrate


New MM 1113.00 Hydrocodone Hydrogen Tartrate 2.5-Hydrate [Controlled Substance]
N x

(A)

100 mg

MM 0037.00

Imp. A (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]


HO O

(A)

250 mg

OH

MM 0280.00

Imp. A (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]


HO O

(A)

250 mg

OH

MM 0004.00

Imp. C (EP) as Monohydrate: Codeine Monohydrate [Controlled Substance]

(A)

100 mg

OH

MM 0442.00

Imp. C (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]


O O

(A)

100 mg

OH

MM 0672.00

Imp. D (EP) as Hydrochloride: 4,5-Epoxy-14hydroxy-3-methoxy-17-methylmorphinan-6one Hydrochloride (Oxycodone Hydrochloride) [Controlled Substance]


O

N HO x

(A)

100 mg

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119

Pharmaceutical impurities
Code Product Price
N

Unit

MM 0004.02

Imp. E (EP): 7,8-Didehydro-4,5-epoxy-3-methoxy17-methylmorphinan-6-one (Codeinone)


O O N

(A)

100 mg

MM 0004.03

Imp. F (EP): 7,8-Didehydro-4,5-epoxy-3,6-dimethoxy17-methylmorphinan (Methylcodeine; O-Methylcodeine) [Controlled Substance]


O O

(A)

100 mg

O
O

MM 0630.01

Imp. H (EP): Diphenylmethanone (Benzophenone)

(B)

100 mg

Hydrocortisone
MM 0185.00 Hydrocortisone
HO O OH OH

(A)

500 mg

MM 0193.00

Imp. A (EP): Prednisolone


HO

O OH OH

(A)

500 mg

MM 0214.00

Imp. B (EP): 17,21-Dihydroxypregn-4-ene3,11,20-trione (Cortisone)


O

O O OH OH

(A)

500 mg

MM 0187.00

Imp. C (EP): Hydrocortisone Acetate (Hydrocortisone 21-Acetate)


O

O HO OH O

(A)

500 mg

MM 0185.06

Imp. D (EP): 6,11,17,21-Tetrahydroxypregn-4ene-3,20-dione (6-Hydroxyhydrocortisone)


O

O HO OH OH

(A)

100 mg

OH

MM 0185.07

Imp. E (EP): 11,17,21-Trihydroxypregna-4,6diene-3,20-dione (-Hydrocortisone)


O

O HO OH OH

(D)

100 mg

MM 0185.08

Imp. F (EP): 17,21-Dihydroxypregn-4-ene-3,20-dione (Reichstein's Substance S)


O

O OH OH

(A)

100 mg

MM 0185.13

6-Hydroxyhydrocortisone
HO

O OH OH

(D)

50 mg

O OH

Hydrocortisone Acetate
MM 0187.00 Hydrocortisone Acetate
HO O OH O O

(A)

500 mg

MM 0185.00

Imp. A (Pharmeuropa): 11,17,21-Trihydroxypregn-4-ene-3,20-dione (Hydrocortisone)

O HO OH OH

(A)

500 mg

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Pharmaceutical impurities
Code Product Price
O O O O O O O O

Unit

MM 0187.06

Hydrocortisone 11,17,21-Triacetate

(B)

10 mg

MM 0187.09

11,17,21-Trihydroxypregna-4,6-diene-3,20-dione 21-Acetate
HO

O O O OH

(D)

100 mg

MM 0194.00

Imp. C (Pharmeuropa): 11,17-Dihydroxy-3,20dioxopregna-1,4-dien-21-yl Acetate (Prednisolone Acetate)


O

O HO OH O

(A)

500 mg

MM 0186.00

Imp. D (Pharmeuropa): 17-Hydroxy-3,11,20Trioxopregn-4-en-21-yl Acetate (Cortisone Acetate)


O

O O OH O

(A)

500 mg

Hydrocortisone 17-Butyrate
MM 0188.00 Hydrocortisone 17-Butyrate
HO O O OH O O

(A)

500 mg

MM 0188.01

Hydrocortisone 21-Butyrate
HO

O O O OH

(A)

100 mg

Hydrocortisone Hydrogen Succinate


MM 0185.00 Imp. A (EP): Hydrocortisone
HO O OH OH

(A)

500 mg

MM 0187.00

Imp. B (EP): Hydrocortisone Acetate


HO

O OH O

(A)

500 mg

Hydromorphone Hydrochloride
New MM 0371.00 Hydromorphone Hydrochloride [Controlled Substance]
N x HCl

(A)

100 mg

HO

MM 0037.00

Imp. C (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]


HO O
N

N x HCl x 3 H2O OH

(A)

250 mg

MM 0280.00

Imp. C (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]


HO O

(A)
x H2SO4 x 5 H2O OH 2

250 mg

Hydroxychloroquine Sulphate
MM 0764.00 Hydroxychloroquine Sulphate
Cl N x H2SO4 HN OH

(A)

500 mg

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121

Pharmaceutical impurities
Code Product Price
Cl N x 2 HCl HN OH

Unit

MM 0764.02

Desethylhydroxychloroquine Dihydrochloride

(D)

100 mg

N H

MM 0764.04

O-Acetylhydroxychloroquine

Cl

(A)
O O

100 mg

HN

MM 0764.05

Hydroxychloroquine N-Oxide Dihydrochloride

Cl

(B)
x 2 HCl OH O

10 mg

HN

Hydroxyethyl Salicylate
MM 0112.00 Hydroxyethyl Salicylate
O O OH OH

(A)

500 mg

MM 0045.00

Imp. A (EP): Salicylic Acid

O OH OH

(A)

500 mg

Hydroxyzine Hydrochloride
MM 0852.00 Hydroxyzine Hydrochloride
Cl N x 2 HCl N O OH

(A)

250 mg

MM 0380.01

Imp. A (EP): (RS)-1-[(4-Chlorophenyl) phenylmethyl]piperazine

Cl N

NH

(A)

100 mg

MM 0852.02

Imp. B (EP) as Dihydrochloride: 2-[2-[4-(Diphenylmethyl)piperazin-1-yl]ethoxy]ethanol Dihydrochloride (Decloxizine Dihydrochloride)

N N

OH x 2 HCl

(A)

50 mg

Hymechromone
MM 0294.00 Hymecromone
HO O O

(A)

500 mg

MM 0294.01 MM 0294.02

Imp. A (EP): 1,3-Dihydroxybenzene (Resorcinol) Imp. B (EP): 7-Hydroxy-2-methyl-4H-1-benzopyran-4-one


HO

HO

OH

(B) (A)

100 mg 100 mg

MM 0294.03

2,4-Dihydroxyacetophenone

HO

OH O

(B)

100 mg

MM 0294.04

Hymecromone Acetate
O

(A)

100 mg

MM 0294.50

7-Acetoxy-3-acetyl-2-4H-1-benzopyran-4-one
O

(A)
O

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Hyoscine Butylbromide
MM 0683.00 Hyoscine Butylbromide
H O H O OH H
H O H O OH H N H H O x HBr x 3 H2O

(A)
+ N O Br

500 mg

MM 0546.00

Imp. A (EP) as Hydrobromide Trihydrate: Hyoscine Hydrobromide Trihydrate

(A)

500 mg

MM 0601.03

Imp. B (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic Acid; Tropic Acid)

O OH OH

(A)

100 mg

Hyoscine Hydrobromide
MM 0546.00 Hyoscine Hydrobromide Trihydrate
H O H O OH H
O

H N H
H H O H N H H O

(A)
O x HBr x 3 H2O

500 mg

MM 0546.06

Imp. C (EP): (1R,2R,4S,5S,7s)-9-Methyl-3-oxa9-azatricyclo[3.3.1.02,4]non-7-yl 2-Phenylprop2-enoate (Apohyoscine) Imp. D (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic Acid; Tropic Acid) Hyoscine N-Oxide Hydrobromide

(A)

100 mg

MM 0601.03

O OH OH

(A)

100 mg

MM 0546.07

H O H O OH H N

H O H x HBr

(A)

100 mg

Hyoscyamine Sulphate
MM 0601.03 Imp. A (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic Acid; Tropic Acid) Imp. D (EP) as Hydrobromide Trihydrate: Hyoscine Hydrobromide Trihydrate
H O H O OH H
O

O OH OH

(A)

100 mg

MM 0546.00

H N H
H

(A)
O x HBr x 3 H2O

500 mg

MM 0289.01

Imp. G (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl8-azabicyclo[3.2.1]oct-3-yl 2-Phenylprop-2-enoate Hydrochloride (Apoatropine Hydrochloride)

(D)
N x HCl

100 mg

H O H

Ibandronate Sodium Monohydrate


MM 1326.00 Ibandronate Sodium Monohydrate
N OH O OH HO P x H2O OH P ONa O

(A)

100 mg

Ibuprofen
MM 0002.00 Ibuprofen
O OH

(A)

500 mg

MM 0002.13

Imp. A (EP): (2RS)-2-[3-(2-Methylpropyl)phenyl]propanoic Acid


O

OH

(A)

100 mg

MM 0002.01

Imp. B (EP):(2RS)-2-(4-Butylphenyl)propanoic Acid


O

OH

(A)

100 mg

MM 0002.10

Imp. C (EP): (2RS)-2-[4-(Methylpropyl)phenyl]propanamide


O

NH2

(A)

100 mg

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123

Pharmaceutical impurities
Code Product Price
OH O

Unit

MM 0002.11

Imp. D (EP): (2RS)-2-(4-Methylphenyl)propanoic Acid

(A)

100 mg

MM 0002.04

Imp. E (EP): 1-[4-(2-Methylpropyl)phenyl]ethanone

(A)

100 mg

MM 0002.28

Imp. F (EP): 3-[4-(2-Methylpropyl)phenyl]propanoic Acid

O OH

(A)

100 mg

MM 0002.38

Imp. G (EP): (1RS,4RS)-7-(2-Methylpropyl)-1[4-(2-methylpropyl)phenyl]-1,2,3,4-tetrahydronaphthalene-1,4-dicarboxylic Acid

OH

(D)

50 mg

OH O

and enantiomer

MM 0002.30

Imp. H (EP):(3RS)-1,3-Bis[4-(2-methylpropyl) phenyl]butan-1-one Imp. I (EP): 1-(2-Methylpropyl)-4-[(3RS)-3[4-(2-methylpropyl)phenyl]butyl]benzene Imp. J (EP): (2RS)-2-[4-(2-Methylpropanoyl)phenyl] propanoic Acid

(D)

100 mg

MM 0002.31

(A)

50 mg

MM 0002.02

OH O O

(A)

100 mg

MM 0002.26

Imp. K (EP): (2RS)-2-(4-Formylphenyl) propanoic Acid Imp. L (EP): 2-[4-(1-Hydroxy-2-methylpropyl)phenyl] propanoic Acid (1-Hydroxyibuprofen)

OH O O

(A)

100 mg

MM 0002.24

OH O OH

(A)

100 mg

MM 0002.34

Imp. M (EP): (2RS)-2-Hydroxy2-[4-(2-methylpropyl)phenyl]propanoic Acid Imp. N (EP): (2RS)-2-(4-Ethylphenyl)propanoic Acid

OH OH O

(A)

100 mg

MM 0002.35 MM 0002.33

OH O

(A) (A)

100 mg 100 mg

Imp. O (EP): 2-[4-(1-Methylpropyl)phenyl]propanoic Acid


O

OH

MM 0002.19 MM 0002.36 MM 0002.37 MM 0002.03

Imp. P (EP):(2RS)-2-[4-(2-Methylpropyl)phenyl]propan-1-ol Imp. Q (EP): 2-[4-(2-Methylpropyl)phenyl]ethanol Imp. R (EP): 1,1'-(Ethane-1,1-diyl)-4,4'-(2methylpropyl)dibenzene 4-Isobutylbenzoic Acid
O

OH

(A) (A) (A) (A)

100 mg 100 mg 100 mg 100 mg

OH

OH

MM 0002.07

2-(4-Isobutyrylphenyl)propanamide
O O

NH2

(A)

100 mg

MM 0002.08

4-Acetylbenzoic Acid
O

O OH

(A)

100 mg

MM 0002.09

4-Isobutyrylacetophenone
O

(A)

100 mg

MM 0002.14

2-(4-Isobutyrylphenyl)propane
O

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
OH O O

Unit

MM 0002.15

2-Hydroxypropyl 2-(4-Isobutylphenyl)propanoate

(A)

100 mg

MM 0002.16

1-Hydroxyprop-2-yl 2-(4-Isobutylphenyl)propanoate
O

on request
OH

MM 0002.17

2,3-Dihydroxypropyl 2-(4-Isobutylphenyl)propanoate
O

OH O OH

(D)

50 mg

MM 0002.18

1,3-Dihydroxyprop-2-yl 2-(4-Isobutylphenyl)propanonate
O

on request
OH OH

MM 0002.20

2-(4-n-Propylphenyl)propanoic Acid
O

OH

(A)

100 mg

MM 0002.21

2-(4-Isobutylphenyl)propionitrile
N

(A)

100 mg

MM 0002.23

Isopropyl 2-(4-Isobutylphenyl)propanonate
O

(A)

100 mg

MM 0002.25

1-Ethyl-4-isobutylbenzene

(A)

100 mg

MM 0002.29

(1RS,4SR)-7-(2-Methylpropyl)-1-[4-(2-methylpropyl)phenyl]-1,2,3,4-tetrahydronaphthalene1,4-dicarboxylic Acid

OH

(D)

100 mg

OH O

and enantiomer

MM 0002.32

2-[4-(2-Hydroxy-2-methylpropyl)phenyl]propanoic Acid (2-Hydroxyibuprofen)


HO

OH O

(A)

100 mg

MM 0002.45

(2SR)-2-(4-Isobutylphenyl)-N-((SR)1-phenylethyl)propanamide
O and enantiomer

H N

(A)

100 mg

MM 0002.46

(2SR)-2-(4-Isobutylphenyl)-N-((RS)1-phenylethyl)propanamide
O and enantiomer

H N

(A)

100 mg

MM 0002.48 MM 0002.50

4-Isobutylstyrene 1-(4-Isobutylphenyl)ethanol
OH

(B) (A)

10 mg 100 mg

MM 0002.51

4-(1-Hydroxy-2-methylpropyl)acetophenone
OH

(A)

100 mg

New MM 0002.56

Ibuprofen Ethyl Ester


O

(A)

100 mg

MM 0002.53

Ibuprofen Methyl Ester


O

(A)

100 mg

MM 0002.57

1-(4-Isopropylphenyl)ethanone (4-Isopropylacetophenone) 2-(4-Isopropylphenyl)acrylic Acid


O

(A)

100 mg

MM 0002.59

OH

(C)

50 mg

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125

Pharmaceutical impurities
Code Product Price Unit

Idoxuridine
MM 0791.00 Idoxuridine
HN HO O O N O I

(A)

500 mg

OH

Imidocarb Dipropionate
MM 0742.00 Imidocarb Dipropionate
H N N O N H N H H N N O x2 OH

(A)

100 mg

Imipramine Hydrochloride
MM 0077.00 Imipramine Hydrochloride
N N x HCl

(A)

500 mg

MM 0589.00

Imp. A (EP) as Hydrochloride: 3-(10,11-Dihydro5H-dibenzo[b,f]azepin-5-yl)-N-methylpropan-1amine Hydrochloride (Desipramine Hydrochloride) Imp. B (EP): 3-(5H-Dibenzo[b,f]azepin-5-yl)-N,Ndimethylpropan-1-amine (Depramine; 10,11-Dehydroimipramine)

(A)
N N H x HCl

250 mg

MM 0077.05

(A)
N N

100 mg

MM 0077.08

Imp. C (EP) as Hydrochloride: 10-[3-(Dimethylamino)propyl]acridin-9(10H)-one Hydrochloride


O

(A)
N N x HCl

100 mg

MM 0077.03

N-[3-(10,11-Dihydro-5H-dibenzo-[b,f]azepin-5-yl) propyl]-N,N',N'-trimethylpropane-1,3-diamine Dihydrochloride

(B)
N N N

10 mg

x 2 HCl

MM 0077.04

10-Hydroxyimipramine BH3-Aduct
N N x BH3

(A)

100 mg

HO

MM 0076.06

Iminodibenzyl
NH

(B)

100 mg

MM 0077.12

Imipramine N-Oxide
N N O

(A)

100 mg

Indanazoline Hydrochloride
MM 0588.02 4-Aminoindan Hydrochloride
x HCl NH2

(A)

100 mg

Indapamide
MM 0477.00 Indapamide
O H2 N Cl O S O N H N

(A)

250 mg

MM 0477.01

Imp. A (EP): (2RS)-2-Methyl-1-nitroso2,3-dihydro-1H-indole

(A)
ON N

100 mg

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Pharmaceutical impurities
Code Product Price
O O S H2N Cl O N H N

Unit

MM 0477.02

Imp. B (EP): 4-Chloro-N-(2-methyl-1Hindol-1-yl)-3-sulphamoylbenzamide 4-Chloro-3-sulfamoylbenzoic Acid

(A)

100 mg

MM 0477.04

O H2N

O S

O OH

(C)

100 mg

Cl

MM 0477.05

N-(4-Chloro-3-sulfamoylbenzoyl)-2-methylindoline

O H2 N

O S

O N

(D)

100 mg

Cl

MM 0477.07 MM 0477.08 MM 0477.09

Triethylamine
N

(C) (A)
HN

100 mg 100 mg 100 mg

2-Methylindoline 1-Amino-2-methylindoline Hydrochloride


H2N N

x HCl

(D)

Indometacin
MM 0584.00 Indometacin
Cl O O N O OH

(A)

500 mg

MM 0063.03

Imp. A (EP): 4-Chlorobenzoic Acid


Cl

O OH

(B)

100 mg

MM 0584.02

3,4-Dichloroindometacin ([1-(3,4-Dichlorobenzoyl)5-methoxy-2-methylindol-3-yl]acetic Acid)

O Cl Cl O N O OH

(A)

50 mg

Indoramin Hydrochloride
MM 0802.02 Imp. A (BP): 3-(2-Bromoethyl)indole
H N

(A)
Br

100 mg

New MM 0802.05

Imp. B (BP): N-(1-Benzyl-4-piperidyl)benzamide


N

H N O

(A)

50 mg

Ipecacuanha
MM 0131.02 Emetine Dihydrochloride
O O N H HN x 2 HCl O O

(A)

100 mg

Ipratropium Bromide
MM 0601.03 Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (dl-Tropic Acid) Imp. D (EP): 2-Phenylpropenoic Acid (Atropic Acid)
O OH OH

(A)

100 mg

MM 0289.03

O OH

(A)

100 mg

Iprindole Hydrochloride
MM 0478.00 Iprindole Hydrochloride
N N x HCl

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Irbesartan
MM 0862.01 Imp. A (EP): 1-(Pentanoylamino)-N-[[2'-(1Htetrazol-5-yl)biphenyl-4-yl]methyl]cyclopentanecarboxamide
O N H N N HN N

(A)

50 mg

NH O

Isoamyl Benzoate
MM 1086.00 Isoamyl Benzoate
O O

(A)

500 mg

Isoconazol Nitrate
MM 0541.00 Isoconazole Nitrate
Cl Cl O Cl N N Cl

(A)
x HNO3

100 mg

MM 0281.01

Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2(1H-imidazol-1-yl)ethanol


HO Cl

(A)

100 mg

Cl

MM 0541.02

Imp. B (EP) as Nitrate: (2RS)-2-[(2,6-Dichlorobenzyl)oxy]2-(2,4-dichlorophenyl)ethanamine Nitrate


Cl Cl O Cl

Cl

(D)
x HNO3 NH2

100 mg

MM 0281.00

Imp. C (EP) as Nitrate: 1-[(2RS)2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]1H-imidazole Nitrate (Miconazole Nitrate)

Cl

(A)
x HNO3

500 mg

Cl O Cl Cl N N

Isoflurane
MM 0500.02 Imp. B (EP): 2-(Difluoromethoxy)-1,1,1-trifluoroethane
F F F F
Cl F F F Cl F F F Cl O F F F O F Cl

(A)
F

100 mg

MM 0500.03

Imp. C (EP): (2RS)-2-Chloro-2-(chlorodifluoromethoxy)1,1,1-trifluoroethane Imp. D (EP): 1,1-Dichloro-1-(difluoromethoxy)-2,2,2-trifluoroethane

(A)

100 mg

MM 0500.04

(A)

100 mg

MM 0500.05 MM 0500.06

Imp. E (EP): 1,1-Dichloro-1-(chlorodifluoromethoxy)-2,2,2trifluoroethane Imp. F (EP): Acetone

Cl F F F

Cl F O

F Cl

(A) (C)

100 mg 100 mg

Isoproturon
MM 2503.02 3-(2-Isopropylphenyl)-1,1-dimethylurea
H N O

(A)
N

100 mg

MM 2503.03

3-(3-Isopropylphenyl)-1,1-dimethylurea

H N O

(A)

100 mg

Isosorbide Dinitrate
MM 0126.05 Imp. B (EP): Isosorbide 2-Nitrate
O O HO H H O NO2

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
H O O O2 N O H
H O O HO H O

Unit

MM 0502.00

Imp. C (EP): Isosorbide Mononitrate (Isosorbide 5-Nitrate)

OH

(A)

500 mg

MM 0126.01

2-Monomethyl Isosorbide

on request

MM 0126.02

Dimethyl Isosorbide

H O

(B)

100 mg

O O H H O O HO H OH

MM 0126.03

Isosorbide

(A)

500 mg

MM 0126.04

Isomannit initrate
O

O NO2

on request

O O2 N O H

Isosorbide Mononitrate
MM 0502.00 Isosorbide Mononitrate
H O O O2 N O H O NO2 OH

(A)

500 mg

MM 0126.05

Imp. C (EP): Isosorbide 2-Nitrate


O

(A)

100 mg

O HO H H O O HO H OH

MM 0126.03

Isosorbide

(A)

500 mg

Isoxsuprine Hydrochloride
MM 0576.00 Isoxsuprine Hydrochloride
HO and enantiomere OH H N

(A)
O x HCl

500 mg

Itraconazole
MM 0258.00 Itraconazole
N N N O

(A)

100 mg

N N Cl O O O N N N and enantiomer Cl

MM 0258.02

Imp. A (EP): 4-[4-[4-(4-Methoxyphenyl)piperazin1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro3H-1,2,4-triazol-3-one

(A)
N N N O

100 mg

N N

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129

Pharmaceutical impurities
Code Product Price Unit

MM 0258.04

Imp. C (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl2,4-dihydro-3H-1,2,4-triazol-3-one

(A)
N N N O

100 mg

N N Cl O O O N N N and enantiomer Cl

MM 0258.05

Imp. D (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1methylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one

(A)
N N N O

100 mg

N N Cl O O O N N N and enantiomer Cl

MM 0258.07

Imp. F (EP): 2-Butyl-4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4dihydro-3H-1,2,4-triazol-3-one

(A)
N N N O

100 mg

N N Cl O O O N N N
N NH N O

and enantiomer Cl

MM 0258.10

2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]3H-1,2,4-triazol-3-one

(A)

100 mg

N N

MM 0258.11

cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)1,3-dioxolane-4-methanol Mesilate
S O O O

and enantiomer Cl O O N N N Cl

(A)

100 mg

Ketamine Hydrochloride
MM 0144.00 Ketamine Hydrochloride
O NH x HCl Cl

(A)

500 mg

MM 0144.01

Imp. A (EP): 1-[(2-Chlorophenyl)(methylimino)methyl]cyclopentanol

HO

Cl

(A)

100 mg

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Code Product Price
O OH Cl

Unit

MM 0144.02

Imp. B (EP): (2RS)-2-(2-Chlorophenyl)-2-hydroxycyclohexanone Dehydronorketamine Hydrochloride


O

(A)

100 mg

New MM 0144.07

NH2

Cl x HCl

(A)

50 mg

Ketoconazole
MM 0145.00 Ketoconazole
O N O N and enantiomer Cl O O N N Cl

(A)

500 mg

MM 0145.04

Imp. D (EP): 1-[4-[[(2RS,4SR)2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)1,3-dioxolan-4-yl]methoxy]phenyl]piperazine


N HN

Cl O O O N N and enantiomer
O N N

Cl

(A)

100 mg

MM 0145.05

1-Acetyl-4-(4-hydroxyphenyl)piperazine

OH

(A)

100 mg

Ketoprofen
MM 0001.00 Ketoprofen
O OH O

(A)

500 mg

MM 0001.01

Imp. A (EP):1-(3-Benzoylphenyl)ethanone (3-Acetylbenzophenone) Imp. B (EP): (3-Benzoylphenyl)acetic Acid


O

(A)

100 mg

MM 0001.03

OH O

(A)

100 mg

MM 0001.07

Imp. C (EP):3-[(1RS)-1-Carboxylethyl]benzoic Acid


HO

O OH O

(A)

100 mg

MM 0001.12

Imp. D (EP): (2RS)-2-[3-(4-Methylbenzoyl)phenyl] propanoic Acid Imp. E (EP):(2RS)-2-(3-Benzoylphenyl)propanamide

O OH O O NH2 O

(D)

100 mg

MM 0001.05

(A)

100 mg

MM 0001.04

Imp. F (EP): (2RS)-2-(3-Benzoylphenyl)propanenitrile

O N

(A)

100 mg

MM 0001.20

Imp. G (EP): 3-[(1RS)-1-Cyanoethyl]benzoic Acid


HO

O N

(A)

100 mg

MM 0001.22

Imp. H (EP): 3-(Cyanomethyl)benzoic Acid


HO

(A)
N

100 mg

MM 0001.14

Imp. I (EP): (3-Benzoylphenyl)ethanenitrile

O N

(A)

100 mg

MM 0001.23

Imp. J (EP): (2RS)-2-[3-(2,4-Dimethylbenzoyl)phenyl]propanoic Acid 3-Ethylbenzophenone

O OH O

(D)

50 mg

MM 0001.02

(A)

100 mg

MM 0001.11

3-(1-Hydroxyethyl)benzophenone

OH

(A)

100 mg

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131

Pharmaceutical impurities
Code Product Price
O

Unit

MM 0001.13

3-Methylbenzophenone

(B)

100 mg

MM 0001.17

3-(1-Methoxyethyl)benzophenone

(A)

100 mg

MM 0001.18

2-[3-(-Hydroxybenzyl)phenyl]propanoic Acid

OH OH O

(A)

100 mg

MM 0001.19

Ethyl 2-(3-Benzoylphenyl)propionate (Ketoprofen Ethyl Ester) Isopropyl 2-(3-Benzoylphenyl)propionate

O O O O O O

(A)

100 mg

MM 0001.21

(A)

100 mg

MM 0001.50

3-(1-Acetoxyethyl)benzophenone

O O

(A)

100 mg

MM 0001.32

Methyl 2-(3-Benzoylphenyl)propionate (Ketoprofen Methyl Ester) 2-Ethylhexyl 2-(3-Benzoylphenyl)propionate (Ketoprofen 2-Ethylhexyl Ester)
O

O O O

(A)

100 mg

MM 0001.33

(A)
O O

100 mg

Ketorolac Trometamol
MM 0851.00 Ketorolac Trometamol
N O O OH x HO OH NH 2 OH

(A)

250 mg

MM 0851.03

Imp. I (EP): Phenyl(2,3-dihydro-1H-pyrrolizin5-yl)methanone


O

(A)
N

100 mg

Ketotifen Hydrogen Fumarate


MM 0180.00 Ketotifen Hydrogen Fumarate
O S N O x HO O OH

(A)

250 mg

MM 0180.04

Ketotifen
O

(A)

100 mg

MM 0180.08

Imp. B (EP): (4RS)-10-Methoxy-4-(1-methylpiperidin-4-yl)-4H-benzo[4,5]cyclohepta[1,2b]thiophen-4-ol

S O OH

(A)

100 mg

MM 0180.07

Imp. D (EP): 4-[(aRaS)-1-Methylpiperidin-4ylidene]-4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one N-Oxide (Ketotifen N-Oxide) 10-Methoxy-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-4-one

O S O N

(A)

100 mg

MM 0180.11

S O O

(A)

100 mg

New MM 0180.12

N-Desmethylketotifen Hydrogen Fumarate


O

NH O x HO O OH

(A)

50 mg

132

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Pharmaceutical impurities
Code Product Price Unit

Labetalol Hydrochloride
MM 0438.00 Labetalol Hydrochloride
HO O NH2
OH H N x HCl HO O OH

OH

H N x HCl

(A)

500 mg

New MM 0438.01

Imp. A (EP) as Hydrochloride: 2-Hydroxy5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)-amino]ethyl]benzoic Acid Hydrochloride

(A)

50 mg

Lacidipine
MM 0407.00 Lacidipine
O O O H N O O O

(A)

100 mg

MM 0407.01

Imp. A (BP): Ethyl Methyl (E)-4-{2-[2-(tertButoxycarbonyl)vinyl]phenyl}-1,4-dihydro-2,6dimethyl-pyridine-3,5-dicarboxylate

H N O O O O O O

(A)

100 mg

MM 0407.02

Imp. B (BP): Diethyl (E)-4-{2-[2-(tert-Butoxycarbonyl)vinyl]phenyl}-2,6-dimethylpyridine3,5-dicarboxylate

N O O O O O O

(A)

100 mg

Lamivudine
MM 0749.00 Lamivudine
N O O S HO N NH2

(A)

100 mg

MM 0045.00

Imp. C (EP): Salicylic Acid

O OH OH

(A)

500 mg

MM 0749.05

Imp. E (EP): 4-Aminopyrimidin-2(1H)-one(Cytosine)


N O

NH2

(A)

100 mg

N H O HN

MM 0593.03

Imp. F (EP): Pyrimidine-2,4(1H,3H)-dione (Uracil)


O

(C)

100 mg

N H

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133

Pharmaceutical impurities
Code Product Price Unit

Lamotrigine
MM 0922.00 Lamotrigine
N N N Cl Cl NH2 NH2

(A)

100 mg

MM 0922.01

Imp. A (EP): 3-Amino-6-(2,3-dichlorophenyl)1,2,4-triazin-5(4H)-one


Cl

NH2 NH

(A)

100 mg

Cl

MM 0922.03

Imp. C (EP): (2Z)-[2-(Diaminomethylidene)diazanylidene](2,3-dichlorophenyl)acetonitrile


Cl

NH2 NH2 N

(A)

100 mg

Cl

MM 0922.04

Imp. D (EP): 6-(2,3-Dichlorophenyl)-1,2,4triazine-3,5(2H,4H)-dione

H N

O NH

(A)

50 mg

Cl Cl

MM 0922.05

Imp. E (EP): 2,3-Dichlorobenzoic Acid

O OH Cl Cl

(A)

100 mg

MM 0922.07

Imp. G (EP): 6-(2,4-Dichlorophenyl)-1,2,4triazine-3,5-diamine


Cl

Cl

N N NH2

NH2

(A)

50 mg

Lansoprazole
MM 0474.00 Lansoprazole
N NH S O N O F F F

(A)

100 mg

MM 0474.07

Imp. A (EP): 2-[(RS)-[[3-Methyl-1-oxido4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]sulphinyl]-1H-benzimidazole (Lansoprazole N-Oxide) Imp. B (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]sulphonyl]-1Hbenzimidazole (Lansoprazole Sulphone) Imp. C (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]sulphanyl]-1Hbenzimidazole Imp. D (EP): 1H-Benzimidazol-2-ol

NH N S O O N O

F F

(D)

100 mg

MM 0474.01

NH N S O O O N

F F

(A)

100 mg

MM 0474.06

NH N S N O

F F

(A)

100 mg

MM 0474.03

NH N OH
NH N SH

(B)

100 mg

MM 0474.05

Imp. E (EP): 1H-Benzimidazole-2-thiol

(A)

100 mg

MM 0474.02

Imp. F (EP): 2-[(RS)-[(4-Chloro-3-methylpyridin2-yl)methyl]sulphinyl]-1H-benzimidazole


N

NH S O N
O

(A)
Cl

100 mg

MM 0474.04

4-Ethoxyacetophenone
O

(C)

100 mg

MM 0474.08

Lansoprazole Sulphone N-Oxide


N

NH S O O N O
F Cl N O

F O

F F

(A)

100 mg

MM 0474.09

2-Chloromethyl-3-methyl-4-(2,2,2-trifluoroethoxy pyridine Hydrochloride

F F x HCl

(A)

100 mg

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Code Product Price
S O N N N

Unit

MM 0474.13

1-Methyl-12-thioxopyrido[1',2':3,4]imidazo[1,2-a] benzimidazol-2(12H)-one

(D)

100 mg

Leflunomide
MM 0859.00 Leflunomide
N O O F H N F F

(D)

100 mg

MM 0859.01

Imp. A (EP) as Hydrochloride: 4-(Trifluoromethyl)aniline Hydrochloride Imp. B (EP): (2Z)-2-Cyano-3-hydroxy-N-[4(trifluoromethyl)phenyl]but-2-enamide (Teriflunomide)

H2N F F F x HCl

(A)

100 mg

MM 0859.02

N H N OH O F F F
F F

(A)

100 mg

MM 0859.03

Imp. C (EP): 5-Methyl-N-[3-(trifluoromethyl)phenyl]isoxazole-4-carboxamide Imp. D (EP): 5-Methylisoxazole-4-carboxylic Acid

N O O H N

(A)

100 mg

MM 0859.04

N O O OH

(A)

100 mg

MM 0859.05

Imp. E (EP): 3-Methyl-N-[4-(trifluoromethyl)phenyl] isoxazole-4-carboxamide

N O O F H N F F

(A)

50 mg

MM 0859.06

Imp. F (EP): 5-Methyl-N-[2-(trifluoromethyl)phenyl]isoxazole-4-carboxamide

N O O H N

F F

(A)

100 mg

MM 0859.07

Imp. G (EP): 5-Methyl-N-(4-methylphenyl)isoxazole-4-carboxamide Imp. H (EP): 2-Cyano-N-[4-(trifluoromethyl)phenyl]acetamide

N O O H N

(A)

100 mg

MM 0859.08

N H N O F F F

(A)

50 mg

Letrozole
New MM 1143.02 Imp. A (EP): 4,4'-(4H-1,2,4-Triazol-4-ylmethylene)dibenzonitrile
N N

(A)

50 mg

N N N

Levamisole Hydrochloride
MM 0706.00 MM 0706.04 Levamisole Hydrochloride Imp. D (EP): 6-Phenyl-2,3-dihydro-imidazo[2,1-b]thiazole
N N
N N

S x HCl
S

(A) (A)

100 mg 100 mg

Levetiracetam
New MM 1372.00 Levetiracetam
O O N NH2

(A)

50 mg

Levocetirizine Dihydrochloride
MM 1035.00 Levocetirizine Dihydrochloride
O Cl N x 2 HCl N O OH

(D)

100 mg

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135

Pharmaceutical impurities
Code Product Price Unit

Levodopa
MM 0262.00 Levodopa
O HO HO NH 2 OH

(A)

500 mg

MM 0634.00

Imp. B (EP): (2S)-2-Amino-3-(4-hydroxyphenyl)propanoic Acid (Tyrosine)


HO

O OH NH2
O OH HO O NH2

(A)

100 mg

MM 0262.05

Imp. C (EP): (2RS)-2-Amino-3-(4-hydroxy3-methoxyphenyl)propanoic Acid (3-Methoxy-DL-tyrosine; (DL)-3-O-Methyldopa) 4-Hydroxy-3-methoxymandelic Acid

(A)

100 mg

MM 0262.06

OH OH HO O O

(A)

100 mg

Levodropropizine
MM 1246.02 Imp. B (EP) as Hydrochloride: 1-Phenylpiperazine Hydrochloride
NH N x HCl

(A)

100 mg

Levofloxacin
MM 0846.00 Levofloxacin
N N F O O O N OH

(A)

100 mg

Levomenthol
MM 0388.00 Levomenthol
OH

(A)

500 mg

Levomepromazine Hydrochloride
MM 0266.00 Levomepromazine Hydrochloride
N S O N x HCl

(A)

500 mg

Levomepromazine Maleate
MM 0019.00 Levomepromazine Maleate
N S O N x O O OH OH

(A)

100 mg

MM 0019.02

Imp. A (EP): 2-Methoxyphenothiazine


NH S O

(A)

100 mg

MM 0019.01

Imp. B (EP): 10-[(2R)-3-(Dimethylamino)-2methylpropyl]-2-methoxy-10H-phenothiazine 5-Oxide (Levomepromazine S-Oxide)


O

(A)
N S O N

100 mg

MM 0019.07

N-Demethyllevomepromazine Hydrochloride
N S O N H x HCl

(D)

100 mg

MM 0019.09

Levomepromazine Sulphone Hydrochloride


N O S O O N x HCl

(A)

100 mg

136

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Pharmaceutical impurities
Code Product Price Unit

Levonorgestrel
MM 0121.00 Levonorgestrel
OH

(A)

250 mg

MM 0121.08

Imp. G (Pharmeuropa): 13-Ethyl-617dihydroxy-18,19-dinor-17-pregn-4-en20-yn-3-one (6-Hydroxylevonorgestrel)


O OH

OH

(D)

50 mg

MM 0121.01

Imp. H (Pharmeuropa): 13-Ethyl-617dihydroxy-18,19-dinor-17-pregn-4-en20-yn-3-one (6-Hydroxylevonorgestrel)


O OH

OH

(D)

100 mg

MM 0121.02

Imp. J (Pharmeuropa): 13-Ethyl-17-hydroxy18,19-dinor-17-pregn-4-en-20-yn-3,6-dione (6-Oxolevonorgestrel, 6-Ketolevonorgestrel)


O O

OH

(D)

100 mg

MM 0121.12

Imp. L (Pharmeuropa): 13-Ethylgon-4-ene-3,17dione (Levodione, 18-Methyl-19-norandrost-4ene-3,17-dione)


O

(D)

100 mg

MM 0121.11

Imp. M (Pharmeuropa): 13-Ethyl-17-hydroxy18,19-dinor-17-pregna-4,6-dien-20-yn-3-one (6-Levonorgestrel, 6,7-Didehydrolevonorgestrel)


O

OH

(D)

100 mg

Lidocaine Hydrochloride
MM 0102.04 MM 0102.00 Lidocaine Hydrochloride Monohydrate Lidocaine
H N O H N O N x HCl x H2O

(A) (A)

500 mg 500 mg

MM 0102.02

Imp. A (EP): 2,6-Dimethylaniline

NH2

(B)

100 mg

MM 0102.01

Imp. B (EP): 2-(Diethylazinoyl)-N-(2,6dimethylphenyl)acetamide (Lidocaine N2Oxide) Imp. C (EP): N-(2,6-Dimethylphenyl)acetamide Imp. D (EP) as Hydrochloride: N-(2,6Dimethylphenyl)-2-(ethylamino)acetamide Hydrochloride (Monoethylglycinexylidide Hydrochloride) Imp. E (EP) as Hydrochloride: 2,2'(Azanediyl)bis[N-(2,6-dimethylphenyl)acetamide] Hydrochloride Imp. F (EP) as Hydrochloride: 2-(Diethylamino)-N-(2,3-dimethylphenyl)acetamide Hydrochloride Imp. G (EP) as Hydrochloride: N-(2,6Dimethylphenyl)-2-[(1-methylethyl)amino]acetamide Hydrochloride Imp. H (EP): 2-Chloro-N-(2,6-dimethylphenyl)acetamide

H N O

O N

(A)

100 mg

MM 0102.08

H N O

(A)

100 mg

MM 0102.05

H N O

(A)
N H x HCl

100 mg

MM 0102.09

H N O

N H

H N O

(A)
x HCl

100 mg

MM 0102.10

H N O
H N O

(A)
N x HCl

100 mg

MM 0102.11

(A)
N H x HCl

100 mg

MM 0102.03

H N O

(B)
Cl

100 mg

MM 0102.12 MM 0102.13

Imp. I (EP) as Hydrochloride: 2-(Diethylamino)N-(2,4-dimethylphenyl)acetamide Hydrochloride

H N O H N O

(A)
x HCl

100 mg 50 mg

Imp. J (EP) as Hydrochloride: 2-(Diethylamino)N-(2,5-dimethylphenyl)acetamide Hydrochloride

(A)
x HCl

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Pharmaceutical impurities
Code Product Price
H N O

Unit

MM 0102.14

Imp. K (EP) as Hydrochloride: N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride

(A)
N x HCl

100 mg

Liothyronine Sodium
MM 0626.00 Liothyronine Sodium
HO I I O I O
I O HO I I O NH2 OH

(A)
NH2 ONa

50 mg

MM 0626.01

Liothyronine

(A)

100 mg

Lisinopril Dihydrate
MM 0598.00 Lisinopril Dihydrate
H N HO O H2N O N O OH x 2 H2O

(A)

100 mg

MM 0598.01

Imp. A (EP): (2RS)-2-Amino-4-phenylbutanoic Acid


NH2 HO O

(A)

100 mg

MM 0598.02

Imp. B (EP) as Hydrate: 4-Methylbenzenesulphonic Acid Hydrate

O O S OH

(C)
x H2O

100 mg

Lomustine
MM 0923.02 MM 0923.03 Imp. B (EP): 1-(2-Chloroethyl)-3-cyclohexylurea
N H O N H O N H N H Cl

(A) (A)

100 mg 100 mg

Imp. C (EP): 1,3-Dicyclohexylurea

Loperamide Hydrochloride
MM 0025.00 Loperamide Hydrochloride
Cl OH

(A)

500 mg

x HCl N

MM 0025.14

Imp. A (EP): 4-[4-(4'-Chlorobiphenyl-4-yl)-4hydroxypiperidin-1-yl]-N,N-dimethyl-2,2diphenylbutanamide

Cl

(A)
OH

50 mg

N O

MM 0025.15

Imp. B (EP) as Bromide: 4-(4-Chlorophenyl)1,1-bis[4-(dimethylamino)-4-oxo3,3-diphenylbutyl]-4-hydroxypiperidinium Bromide


Cl

N OH N+

on request

BrN

MM 0025.04

Imp. C (EP): 4-(4-Chlorophenyl)piperidin-4-ol

Cl OH

(B)

100 mg

N H

138

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Code Product Price Unit

MM 0025.05

Imp. D (EP): 4-(4-Hydroxy-4-phenylpiperidin-1-yl)N,N-dimethyl-2,2-diphenylbutanamide


N

(A)
OH

100 mg

N O

MM 0025.09

Imp. F (EP): Loperamide Oxide

Cl OH

(A)

100 mg

N O

MM 0025.11

Imp. H (EP): 4-[4-(4-Chlorophenyl)-3,6dihydropyridin-1(2H)-yl]-N,N-dimethyl-2,2diphenylbutanamide

Cl

(A)

100 mg

N O

MM 0025.07

Ethyl Diphenylacetate
O O

(A)

100 mg

MM 0025.08

,-Diphenyl--butyrolactone

O O

(A)

100 mg

MM 0025.10

Dimethyl-(tetrahydro-3,3-diphenyl-2-furilidine) ammonium Bromide

O N+ Br-

(A)

100 mg

Loratadine
MM 0257.00 Loratadine
Cl N O O

(A)

100 mg

MM 0257.03

Imp. A (EP): Ethyl 4-[(11RS)-8-Chloro-11hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1carboxylate

Cl OH N

O O

(A)

100 mg

MM 0257.02

Imp. B (EP): 8-Chloro-5,6-dihydro-11Hbenzo[5.6]cyclohepta[1,2-b]pyridin-11-one

Cl O N

(A)

100 mg

MM 0257.08

Imp. C (EP): Ethyl 4-(4,8-Dichloro-5,6-dihydro11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11ylidene)piperidine-1-carboxylate

Cl N

O O

(D)

100 mg

N Cl

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Pharmaceutical impurities
Code Product Price
Cl NH

Unit

MM 0257.01

Imp. D (EP): 8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5Hbenzo[5,6]cyclohepta[1,2-b]pyridine (Descarboethoxyloratadine; Desloratadine)

(A)

50 mg

MM 0257.05

Imp. G (EP): 8-Chloro-11-(1-methylpiperidin-4ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

Cl N

(A)

100 mg

MM 0257.07

Imp. H (EP): Ethyl 4-Oxopiperidine-1-carboxylate


N O

O O

(A)

100 mg

MM 0257.06

(11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin-4-yl)6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine

Cl OH N

(A)

100 mg

Lorazepam
MM 0071.00 Lorazepam [Controlled Substance]
Cl H N N Cl O OH

(A)

100 mg

MM 0071.01

Imp. A (EP): (2-Amino-5-chlorophenyl)(2-chlorophenyl) methanone (2-Amino-2',5-dichlorobenzophenone)

NH2 Cl O Cl

(B)

100 mg

MM 0071.07

Imp. B (EP): (3RS)-7-Chloro-5-(2-chlorophenyl)2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl Acetate (Lorazepam Acetate) [Controlled Substance] Imp. C (EP): 7-Chloro-5-(2-chlorophenyl)1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide

H N Cl N

O O O Cl

(A)

100 mg

MM 0071.06

H N Cl N

(A)

100 mg

O Cl

MM 0071.03

Imp. D (EP): (5RS)-7-Chloro-5-(2-chlorophenyl)4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione


Cl

H N

O O NH Cl

(A)

100 mg

MM 0071.02

Imp. E (EP): 6-Chloro-4-(2-chlorophenyl)quinazoline-2-carbaldehyde


Cl

O N N Cl

(A)

100 mg

MM 0071.04

6-Chloro-4-(2-chlorophenyl)-2-quinazolinecarboxylic Acid
Cl

O N N Cl OH

(A)

100 mg

MM 0071.08

6-Chloro-4-(2-chlorophenyl)-2-quinazolinemethanol
Cl

OH N N Cl

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
H N Cl N Cl O

Unit

MM 0071.09

6-Chloro-4-(2-chlorophenyl)-2(1H)-quinazolinone

(A)

100 mg

Lormetazepam
New MM 0072.00 Lormetazepam [Controlled Substance]
Cl N N Cl O OH

(A)

100 mg

Losartan Potassium
MM 0168.00 Losartan
Cl N OH N N N N NH

on request

MM 0168.14

Imp. B (Pharmeuropa) : [2'-(1H-Tetrazol-5-yl) biphenyl-4-yl]methanol

N N HO HN N

(A)

50 mg

MM 0168.04

Imp. C (Pharmeuropa) : [2-Butyl-5-chloro-1-[[2'(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol4-yl]methanol

Cl N HO N

N N HN N

(D)

50 mg

MM 0168.08

Imp. D (EP) : 2-Butyl-4-chloro-1H-imidazole-5-carbaldehyde


Cl

O NH N

(A)

100 mg

MM 0168.05

Imp. E (EP): 5-(4'-Methylbiphenyl-2-yl)-1H-tetrazole

N N HN N

(A)

50 mg

MM 0168.15

Imp. F (EP) : 5-[4'[[2-Butyl-4-chloro-5-[[(1methylethyl)oxy]methyl]-1H-imidazol-1-yl]methyl]biphenyl-2-yl]-1H-tetrazole (Losartan Isopropyl Ether)

O N N

N N HN N

(A)

100 mg

Cl

MM 0173.04

Imp. G (EP) : Triphenylmethanol


OH

(A)

100 mg

MM 0168.16

Imp. H (EP) : [2-Butyl-4-chloro-1-[[2'-[2(triphenylmethyl)-2H-tetrazol-5-yl]biphenyl4-yl]methyl]-1H-imidazol-5-yl]methanol


Cl

(A)
OH N N

100 mg

N N N N

New MM 0168.17

Imp. I (Pharmeuropa) : 5-[4'-[[2-Butyl-4-chloro5-[[(triphenylmethyl]oxy]methyl]-1H-imidazol1-yl]methyl]biphenyl-2-yl]-1H-tetrazole


Cl

(A)
O N N N N HN N

50 mg

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141

Pharmaceutical impurities
Code Product Price
O O N N N N HN N

Unit

MM 0168.18

Imp. J (EP) : [2-Butyl-4-chloro-1-[[2'-(1Htetrazol-5-yl)biphenyl-4-yl]methyl]-1Himidazol-5-yl]methyl Acetate


Cl

(A)

100 mg

MM 0168.11

Losartan Butyl Ether


Cl

O N N

(A)
N N HN N

50 mg

MM 0168.12

Losartan Methyl Ether


Cl

O N N

N N HN N

(A)

100 mg

Lovastatin
MM 0050.00 Lovastatin
O H OH O O O

(A)

100 mg

MM 0377.00

Imp. A (EP): (1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-1,2,3,7,8,8ahexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Mevastatin)

O O OH O O

(A)

100 mg

MM 0050.01

Imp. B (EP) as Sodium Salt: (3R,5R)-7-[(1S,2S,6R,8S,8aR)2,6-Dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8ahexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt (Lovastatin Hydroxy Acid Sodium Salt)

O OH H O O ONa OH

(A)

100 mg

MM 0050.03

Imp. C (EP): (1S,3R,7S,8S,8aR)-3,7-Dimethyl-8-[2-[(2R)-6-oxo3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen1-yl (2S)-2-Methylbutanoate (Dehydrolovastatin)

O O H

(A)

100 mg

Malic Acid
MM 1332.01 Imp. A (EP): (E)-Butenedioic Acid (Fumaric Acid)
O HO O OH

(B)

100 mg

Maprotiline Hydrochloride
MM 0820.00 Maprotiline Hydrochloride
N H x HCl

(A)

250 mg

MM 0820.01

Imp. A (EP): 3-(9,10-Ethanoanthracen-9(10H)-yl)prop-2-enal


O

(A)

50 mg

MM 0820.02

Imp. B (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen-9(10H)-yl)-N[3-(9,10-ethanoanthracen-9(10H)-yl)propyl]-Nmethylpropan-1-amine Hydrochloride

(C)
N x HCl

10 mg

142

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Pharmaceutical impurities
Code Product Price Unit

MM 0820.03

Imp. C (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen9(10H)-yl)propan-1-amine Hydrochloride

(C)
NH 2 x HCl

10 mg

MM 0820.04

Imp. D (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen9(10H)-yl)-N-methylprop-2-en-1-amine Hydrochloride (Dehydromaprotiline Hydrochloride)

(A)
N H x HCl

50 mg

MM 0820.05

Imp. E (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen9(10H)-yl)-N,N-dimethylpropan-1-amine Hydrochloride

(A)
N x HCl

100 mg

Mebendazole
MM 0882.02 Imp. B (EP): (2-Hydroxy-1H-benzimidazol-5yl)phenylmethanone
O H N OH N

(A)

50 mg

MM 0882.04

Imp. D (EP): Methyl (5-Benzoyl-1-methyl-1Hbenzimidazol-2-yl)carbamate


O

O N NH N O

(A)

50 mg

MM 0882.05

Imp. E (EP): Ethyl (5-Benzoyl-1H-benzimidazol2-yl)carbamate


O

H N N

O O NH

(A)

50 mg

MM 0882.06

Imp. F (EP): Methyl [5-(4-Methylbenzoyl)-1Hbenzimidazol-2-yl]carbamate


O

H N N

O O NH

(A)

50 mg

Mebeverine Hydrochloride
MM 0319.00 Mebeverine Hydrochloride
N O O x HCl O O O

(A)

100 mg

MM 0319.02

Imp. A (Pharmeuropa): 4-Methoxyphenylacetone


O

(B)

100 mg

MM 0319.03

Imp. B (Pharmeuropa) as Hydrochloride: N-[(1RS)1-[(4-Methoxyphenyl)methyl]ethyl]ethanamine Hydrochloride [Controlled Substance]


O

(A)
NH x HCl

100 mg

MM 0319.01

Imp. D (Pharmeuropa): 3,4-Dimethoxybenzoic Acid (Veratric Acid)

O HO O O

(B)

100 mg

Mechlorethamine Hydrochloride
MM 0823.00 Mechlorethamine Hydrochloride
Cl N

x HCl
Cl

(A)

500 mg

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143

Pharmaceutical impurities
Code Product Price Unit

Meclofenoxate Hydrochloride
MM 0044.00 Meclofenoxate Hydrochloride
Cl O O O N x HCl

(A)

500 mg

MM 0044.02

(4-Chlorophenoxy)acetic Acid
Cl

O O OH

(B)

100 mg

Meclozine Hydrochloride
MM 0586.00 Meclozine Dihydrochloride
N Cl N x 2 HCl

(A)

500 mg

MM 0380.09

Imp. B (EP): (RS)-(4-Chlorophenyl)phenylmethanol (4-Chlorobenzhydrol)


OH Cl

(B)

100 mg

MM 0380.10

Imp. C (EP): (4-Chlorophenyl)phenylmethanone (4-Chlorobenzophenone)


O Cl

(B)

100 mg

MM 0586.08

Imp. D (EP): 1,1'(1,3-Phenylenebismethylene)bis[4-[(4-chlorophenyl)phenylmethyl] piperazine]


N Cl N

(A)
N N Cl

50 mg

MM 0586.09

Imp. E (EP): 1-(Diphenylmethyl)-4-[(3-methylphenyl)methyl]piperazine


N N

(A)

50 mg

MM 0380.04

Imp. F (EP): 1,4-Bis[(4-chlorophenyl)phenylmethyl]-piperazine


N Cl N Cl

(A)

100 mg

MM 0380.01

Imp. H (EP): 1-[(RS)-(4-Chlorophenyl)phenylmethyl]piperazine ((RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine)


Cl

(A)
N NH

100 mg

MM 0586.05

Meclozine N-Oxide
N Cl N O

(B)

10 mg

MM 0586.07

N-(3-Methylbenzyl)piperazine Dihydrochloride
HN N x 2 HCl

(A)

100 mg

Medroxyprogesterone
MM 0635.00 Medroxyprogesterone
O OH

(A)

100 mg

144

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Pharmaceutical impurities
Code Product Price Unit

Medroxyprogesterone Acetate
MM 0532.00 Medroxyprogesterone Acetate
O O O O

(A)

100 mg

MM 0532.01

Imp. A (EP): 6-Hydroxy-6-methyl-3,20-dioxopregn-4en-17-yl Acetate (6-Hydroxymedroxyprogesterone Acetate)


O OH

O O O

(D)

100 mg

MM 0635.00

Imp. B (EP):17-Hydroxy-6-methylpregn-4-ene-3,20-dione (Medroxyprogesterone)


O

O OH

(A)

100 mg

MM 0532.05

Imp. E (EP): 6-Methylidene-3,20-dioxopregn-4-en-17-yl Acetate (6-Methylenehydroxyprogesterone Acetate)

O O O

(A)

100 mg

MM 0532.06

Imp. F (EP): 6-Methyl-3,20-dioxo-5-pregnan-17-yl Acetate (4,5-Dihydromedroxyprogesterone Acetate)

O O O

(D)

50 mg

H O O O

MM 0532.07

Imp. G (EP): 6-Methyl-3,20-dioxopregna-4,6-dien-17-yl Acetate (Megestrol Acetate)

(A)

250 mg

MM 0532.09

Imp. H (EP): 3,20-Dioxopregn-4-en-17-yl Acetate (Hydroxyprogesterone Acetate)

O O O O

(A)

100 mg

Mefenamic Acid
MM 0327.00 Mefenamic Acid
O OH NH

(A)

500 mg

MM 0327.01

Imp. A (EP): 2,3-Dimethylaniline

NH2

(B)

100 mg

MM 0327.02

Imp. B (EP): N-(2,3-Dimethylphenyl)2-[(2,3-dimethylphenyl)amino]benzamide

(A)
O N H NH

100 mg

MM 0217.14

Imp. C (EP): 2-Chlorobenzoic Acid

O OH Cl

(A)

100 mg

MM 0278.01

Imp. D (EP): Benzoic Acid

O OH

(B)

100 mg

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145

Pharmaceutical impurities
Code Product Price Unit

Mefloquine Hydrochloride
MM 1198.01 2,8-Bis-(trifluoromethyl)-4-quinolinol
F F F N F F F

(A)

100 mg

OH

Megestrol Acetate
MM 0532.07 Megestrol Acetate
O O O O

(A)

250 mg

MM 0532.00

Imp. A (EP): 6-Methyl-3,20-dioxopregn-4-en-17-yl Acetate (Medroxyprogesterone Acetate)

O O O O

(A)

100 mg

MM 0532.09

Imp. K (Pharmeuropa): 3,20-Dioxopregn-4-en-17-yl Acetate

O O O O

(A)

100 mg

Melatonin
New MM 1373.00 Melatonin
HN O N H O

(A)

100 mg

Meloxicam
MM 0246.00 Meloxicam
O S O N H N O S

(A)
N

500 mg

OH

MM 0084.03

Imp. A (EP): Ethyl 4-Hydroxy-2-methyl2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide Imp. B (EP): 5-Methylthiazol-2-amine

O N O

(A)

100 mg

OH O

MM 0246.01

H2N S

(A)

100 mg

MM 0246.16

Imp. C (EP): N-[(2Z)-3,5-Dimethylthiazol-2(3H)ylidene]-4-hydroxy-2-methyl-2H-1,2-benzothiazine3-carboxamide 1,1-Dioxide

O O S N N OH O S N

(A)

50 mg

MM 0246.17

Imp. D (EP): N-[(2Z)-3-Ethyl-5-methylthiazol-2(3H)-ylidene]4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide

O O S N N OH O S N

(A)

50 mg

MM 0084.02

Imp. E (EP): Methyl 4-Hydroxy-2-methyl2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide Imp. F (EP): Isopropyl 4-Hydroxy-2-methyl-2H1,2-benzothiazine-3-carboxylate 1,1-Dioxide (1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2benzothiazine-3-carboxylate 1,1-Dioxide)

O N O O

(A)

100 mg

OH

MM 0084.12

O O S N O OH O

(A)

100 mg

146

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Pharmaceutical impurities
Code Product Price Unit

Melperone
MM 0321.00 Melperone
N F O

(A)

100 mg

Memantine Hydrochloride
MM 1045.01 1-Hydroxy-3,5-dimethyladamantane
OH

(A)

100 mg

MM 1045.04

1-Chloro-3,5-dimethyladamantane

Cl

(A)

100 mg

Mephenesin
MM 0810.00 Mephenesin
OH O OH

(A)

500 mg

Mephentermine Hemisulphate
MM 0740.00 Mephentermine Hemisulfate
H N x H2 SO4

(A)

500 mg

Mepivacaine Hydrochloride
MM 0368.00 Mepivacaine Hydrochloride
H N O

(A)
N x HCl

500 mg

MM 0102.02

Imp. A (EP): 2,6-Dimethylaniline

NH2

(B)

100 mg

MM 0368.02

Imp. B (EP) as Hydrochloride: (RS)-N-(2,6Dimethylphenyl)piperidine-2-carboxamide Hydrochloride Imp. C (EP): N-(2,6-Dimethylphenyl)pyridine-2-carboxamide

H N O

(A)
N H x HCl

50 mg

MM 0368.03

H N O

(A)
N

100 mg

MM 0368.07

Imp. E (EP): (RS)-N-(4-Chloro-2,6-dimethylphenyl)-1-methylpiperidine-2-carboxamide


Cl

H N O

(A)
N

50 mg

MM 0368.06

Mepivacaine N-Oxide

H N O

(A)
N O

100 mg

Mepyramine Maleate
MM 0559.00 Mepyramine Maleate
N O N O O N

(A)
OH OH

500 mg

MM 0559.02

Imp. A (EP): N-(4-Methoxybenzyl)pyridin-2-amine


O N

NH

(A)

100 mg

MM 0164.03 MM 0084.01

Imp. B (EP): 4-Methoxybenzaldehyde (Anisaldehyde)


O

(C) (B)

100 mg 100 mg

Imp. C (EP): Pyridin-2-amine


N

NH 2

MM 0559.05

Mepyramine N-Oxide Dihydrochloride


N O N

O x 2 HCl

(A)

100 mg

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147

Pharmaceutical impurities
Code Product Price Unit

Mequinol
MM 1131.00 Mequinol
HO O

(A)

500 mg

Mesalazine
MM 0217.00 Mesalazine
O H2N OH OH

(A)

500 mg

MM 0042.01 MM 0042.07 MM 0217.06

Imp. A (EP): 4-Aminophenol Imp. B (EP): 3-Aminophenol

H2N OH

(B) (B)

100 mg 100 mg 100 mg

H2N

OH

Imp. C (EP): 2-Aminophenol


OH NH2

(A)

MM 0217.07

Imp. D (EP): 3-Aminobenzoic Acid

O OH

(A)

100 mg

NH2

MM 0217.09

Imp. F (EP): 3-Amino-2-hydroxybenzoic Acid (3-Aminosalicylic Acid)


NH2

O OH OH

(A)

100 mg

MM 0217.10

Imp. G (EP): 2,5-Dihydroxybenzoic Acid

O HO OH OH

(A)

100 mg

MM 0045.00

Imp. H (EP): 2-Hydroxybenzoic Acid (Salicylic Acid) Imp. I (EP): 2-Hydroxy-5-(phenyldiazenyl)benzoic Acid (Phenylazosalicylic Acid) Imp. K (EP) as Hydrochloride: Aniline Hydrochloride Imp. L (EP): 2-Chlorobenzoic Acid

O OH OH

(A)

500 mg

MM 0217.12

O N N OH OH

(A)

50 mg

MM 0093.17 MM 0217.14

H2N x HCl

(B) (A)

100 mg 100 mg

O OH Cl

MM 0217.15

Imp. M (EP): 2-Chloro-5-nitrobenzoic Acid

O O2N Cl OH

(A)

100 mg

MM 0217.16

Imp. N (EP): 2-Hydroxy-5-nitrobenzoic Acid (5-Nitrosalicylic Acid) Imp. O (Pharmeuropa): 4-Aminobenzenesulphonic Acid (Sulphanilic Acid) 5-Acetaminosalicylic Acid

O O2N OH OH

(A)

100 mg

MM 0227.04

H2N S
O O N H

(A)
OH O O

100 mg

MM 0217.02

OH OH

(A)

100 mg

Metamizole Sodium
MM 0052.00 Metamizole Sodium Monohydrate
O N N N O S O ONa x H2O

(A)

500 mg

MM 0052.02

Imp. A (EP): 4-Formylamino-1,5-dimethyl-2-phenyl-1,2dihydro-3H-pyrazol-3-one (4-Formylaminophenazone)

O N N

H N

(A)

100 mg

148

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Pharmaceutical impurities
Code Product Price
O N N NH2

Unit

MM 0052.04

Imp. B (EP): 4-Amino-1,5-dimethyl-2-phenyl-1,2-dihydro3H-pyrazol-3-one (Ampyrone) Imp. C (EP) as Hydrochloride: 4-Methylamino-1,5-dimethyl2-phenyl-1,2-dihydro-3H-pyrazol-3-one Hydrochloride (4-Methylaminophenazone Hydrochloride) Imp. D (EP): 4-Dimethylamino-1,5-dimethyl-2-phenyl-1,2dihydro-3H-pyrazol-3-one (4,4-Dimethylaminophenazone) 4-Acetylaminophenazone
O N O N N

(A)

100 mg

MM 0052.10

H N x HCl

(A)

100 mg

MM 0052.05

O N N

(A)

100 mg

MM 0052.01

H N

(A)

100 mg

MM 0052.50

4-Benzylideneaminoantipyrine

O N N

(A)
N

100 mg

Metformin Hydrochloride
MM 0056.00 MM 0056.01 MM 0056.07 Metformin Hydrochloride
H2 N NH N H NH N x HCl

(A) (B) (A)

500 mg 100 mg 100 mg

Imp. A (EP): Cyanoguanidine


H2N

NH N H

Imp. B (EP) as Nitrate: (4,6-Diamino-1,3,5triazin-2-yl)guanidine Nitrate


H2N

NH2 N N N N H NH NH2 x HNO3

MM 0056.03

Imp. C (EP): N,N-Dimethyl-1,3,5-triazine-2,4,6-triamine

H2 N N

N N NH2

(A)

100 mg

MM 0056.04

Imp. D (EP): 1,3,5-Triazine-2,4,6-triamine (Melamine)

H2 N N

N N NH2

NH2

(B)

100 mg

MM 0056.05 MM 0056.06

Imp. E (EP) as Hydrochloride:1-Methylbiguanide Hydrochloride


H2 N

NH N H

NH N H
H N

x HCl

(A) (C)

100 mg 100 mg

Imp. F (EP) as Hydrochloride: N-Methylmethanamine Hydrochloride

x HCl

Methadone Hydrochloride
New MM 0531.00 Methadone Hydrochloride [Controlled Substance]
N

(A)
x HCl

100 mg

MM 0531.04

Imp. C (EP) as Hydrochloride: (3RS)-4-(Dimethylamino)-3-methyl-2,2-diphenylbutanenitrile Hydrochloride (Isodidiavalo Hydrochloride)

(A)
x HCl N

50 mg

MM 0531.06

Imp. E (EP): Diphenylacetonitrile

(A)

100 mg

Methamphetamine Hydrochloride
MM 0964.00 New MM 0964.03 Methamphetamine Hydrochloride [Controlled Substance] rac-Methamphetamine Hydrochloride [Controlled Substance]
H N

(A)
x HCl

100 mg 100 mg

H N

x HCl

(A)

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149

Pharmaceutical impurities
Code Product Price Unit

Methaqualone
New MM 1356.00 Methaqualone [Controlled Substance]
N N O

(A)

100 mg

Methohexital
New MM 1347.00 Methohexital
O N O NH O

(A)

100 mg

Methotrexate
MM 0040.00 Methotrexate
NH 2 N H 2N N N N N O O O N H OH

(A)
OH

500 mg

MM 0040.08

Imp. A (EP) as Hydrochloride: (2,4-Diaminopteridin6-yl)methanol Hydrochloride


H2N

NH 2 N N N N OH x HCl

(A)

100 mg

Methoxsalen
MM 0555.00 Methoxsalen
O O O O

(A)

500 mg

MM 0555.01

5-Methoxypsoralen (Bergapten)

(A)

100 mg

Methoxyphenamine Hydrochloride
MM 0655.00 Methoxyphenamine Hydrochloride
O H N x HCl

(A)

500 mg

Methyl Nicotinate
MM 0549.00 Methyl Nicotinate
N O O

(A)

500 mg

MM 0553.00

Imp. A (EP): Nicotinic Acid


N

O OH

(A)

500 mg

Methyl Parahydroxybenzoate
MM 0431.00 Methyl Parahydroxybenzoate
HO O O

(A)

500 mg

MM 0045.01

Imp. A (EP): 4-Hydroxybenzoic Acid


HO

O OH

(B)

100 mg

MM 0498.00

Imp. B (EP): Ethyl 4-Hydroxybenzoate (Ethyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0432.00

Imp. C (EP): Propyl 4-Hydroxybenzoate (Propyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0496.00

Imp. D (EP): Butyl 4-Hydroxybenzoate (Butyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0431.01

Sodium Methyl Parahydroxybenzoate


NaO

O O

(A)

500 mg

150

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Pharmaceutical impurities
Code Product Price Unit

Methylphenidate Hydrochloride
New MM 1031.00 Methylphenidate Hydrochloride [Controlled Substance]
O O H N H and enantiomer x HCl

(A)

100 mg

MM 1031.04

Ritalinic Acid

OH H N

(A)

100 mg

New MM 1031.11

Ritalinic Acid Hydrochloride

OH H N x HCl

(A)

100 mg

Methylprednisolone
MM 0190.00 Methylprednisolone
HO O OH OH

(A)

100 mg

MM 0190.01

Imp. A (EP): 17,21-Dihydroxy-6-methylpregna1,4-diene-3,11,20-trione


O

O O

OH OH

(D)

50 mg

Methylprednisolone Acetate
MM 0191.00 Methylprednisolone Acetate
HO O O O OH

(D)

100 mg

MM 0190.00

Imp. B (EP): Methylprednisolone


HO

OH OH

(A)

100 mg

MM 0194.00

Imp. E (EP): Prednisolone Acetate


HO

O O O OH

(A)

500 mg

Methylprednisolone Hydrogen Succinate


MM 0192.00 Methylprednisolone Hydrogen Succinate Sodium Salt
HO O O O OH ONa O

on request

MM 0190.00

Imp. A (EP): Methylprednisolone


HO

OH OH

(A)

100 mg

MM 0191.00

Imp. C (EP): Methylprednisolone Acetate


HO

O O O OH

(D)

100 mg

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151

Pharmaceutical impurities
Code Product Price Unit

Methyltestosterone
MM 0558.00 Methyltestosterone
OH

(A)

250 mg

MM 0323.00

Testosterone

OH

(A)

500 mg

Metixene Hydrochloride
MM 0125.01 Imp. A (EP): 9H-Thioxanthene
S

(A)

100 mg

MM 0125.02

Imp. B (EP): 9H-Thioxanthen-9-one (Thioxanthone)


S

(B)
O

100 mg

MM 0125.03

3-Chloromethyl-1-methylpiperidine

Cl N

on request

Metoclopramide
MM 0073.00 Metoclopramide Hydrochloride Monohydrate
Cl H2N O O O Cl N H O O O Cl N H O O Cl H2 N O O O N H O O OH O N H N O N H N x HCl x H2O

(A)

500 mg

MM 0073.03

Imp. A (EP): 4-(Acetylamino)-5-chloro-N[2-(diethylamino)ethyl]-2-methoxybenzamide Imp. B (EP): Methyl 4-(Acetylamino)-5-chloro2-methoxybenzoate Imp. C (EP): 4-Amino-5-chloro-2-methoxybenzoic Acid

(A)

100 mg

MM 0073.04

(A)

100 mg

MM 0073.02

(B)

100 mg

MM 0073.05

Imp. D (EP): Methyl 4-(Acetylamino)-2-methoxybenzoate

(A)

100 mg

MM 0073.01 MM 0073.06

Imp. E (EP): N,N-Diethylethane-1,2-diamine


H2 N N

(B)
O Cl H2 N N H OH O Cl H2 N O O O N H OH OH O O H2 N OH O O N H O OH N H N O N

100 mg 100 mg

Imp. F (EP): 4-Amino-5-chloro-N-[2-(diethylamino)ethyl]2-hydroxybenzamide Imp. G (EP): N'-(4-Amino-5-chloro-2-methoxybenzoyl)-N,Ndiethylethane-1,2-diamine N-Oxide (Metoclopramide N-Oxide) Imp. H (EP): 4-(Acetylamino)-2-hydroxybenzoic Acid

(A)

MM 0073.07

(A)

100 mg

MM 0073.08

(A)

100 mg

MM 0073.09

Methyl 4-Amino-2-hydroxybenzoate

(A)

100 mg

MM 0073.10

Methyl 4-(Acetylamino)-2-hydroxybenzoate

(A)

100 mg

152

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Pharmaceutical impurities
Code Product Price Unit

Metoprolol Succinate
MM 0279.00 Metoprolol Succinate
O O x HO O OH OH O H N 2

(A)

100 mg

MM 0027.04

Imp. A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol


O

OH O

H N

(A)

100 mg

MM 0027.01 MM 0027.24

Imp. B (EP): 4-(2-Methoxyethyl)phenol


O

OH

(A) (A)

100 mg 100 mg

Imp. C (EP) as Hydrochloride: 4-[(2RS)-2Hydroxy-3-[(1-methylethyl)amino]propoxy]benzaldehyde Hydrochloride Imp. D (EP): (2RS)-3-[4-(2-Methoxyethyl)phenoxy] propane-1,2-diol

OH O O

H N

x HCl

MM 0027.06

OH O O OH

(A)

100 mg

MM 0027.07

Imp. E (EP): (2RS)-1-[2-(2-Methoxyethyl)phenoxy]3-[(1-methylethyl)amino]propan-2-ol Imp. F (EP): (2RS)-1-[(1-Methylethyl)amino]-3phenoxy-propan-2-ol Imp. G (EP): 2-(4-Hydroxyphenyl)ethanol


HO

OH O O

H N

(A)

100 mg

MM 0027.08

OH O

H N

(A)

100 mg

MM 0027.09 MM 0027.10

OH

(A) (A)

100 mg 100 mg

Imp. H (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]3-[(1-methylethyl)amino]propan-2-ol


HO

OH O

H N

MM 0027.11

(2RS)-1-(4-Ethenylphenoxy)-3-[(1-methylethyl)amino]propan-2-ol Imp. J (EP): 1-[2-Hydroxy3-[(1-methylethyl)amino]propoxy]3-[4-(2-methoxyethyl)phenoxy]propan-2-ol (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]phenoxy]3-[(1methylethyl)amino]propan-2-ol Imp. M (EP) as Dihydrochloride: 1,3-Bis[(1-methylethyl)amino]propan-2-ol Dihydrochloride Imp. N (EP): (2RS)-3-[(1-Methylethyl)amino]propane-1,2-diol Imp. O (EP): 1,1'-[(1-Methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy]propan-2-ol]
O

OH O

H N

(A)

100 mg

MM 0027.12

OH O O O

OH

H N

(A)

50 mg

MM 0027.13

OH O O

H N

(A)

100 mg

MM 0027.28 MM 0027.16 MM 0027.03

H N

OH

H N

(A)
x 2 HCl

100 mg 100 mg 100 mg

OH HO

H N

(A) (A)

OH O N

OH O O

Metoprolol Tartrate
MM 0027.00 Metoprolol Tartrate
O OH x HO O OH
OH O O H N

OH O

H N 2

(A)

500 mg

O OH

MM 0027.04

Imp. A (EP): (2RS)-1-(Ethylamino)3-[4-(2-methoxyethyl)phenoxy]propan-2-ol Imp. B (EP): 4-(2-Methoxyethyl)phenol


O

(A)

100 mg

MM 0027.01

OH

(A)

100 mg

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153

Pharmaceutical impurities
Code Product Price
OH O O OH O O OH H N

Unit

MM 0027.24

Imp. C (EP) as Hydrochloride: 4-[(2RS)-2Hydroxy-3-[(1-methylethyl)amino]propoxy]benzaldehyde Hydrochloride Imp. D (EP): (2RS)-3-[4-(2-Methoxyethyl)phenoxy] propane-1,2-diol Imp. E (EP): (2RS)-1-[2-(2-Methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2-ol Imp. F (EP): (2RS)-1-[(1-Methylethyl)amino]3-phenoxypropan-2-ol Imp. G (EP): 2-(4-Hydroxyphenyl)ethanol

(A)
x HCl

100 mg

MM 0027.06

(A)

100 mg

MM 0027.07

OH O O

H N

(A)

100 mg

MM 0027.08

OH O

H N

(A)

100 mg

MM 0027.09 MM 0027.10

OH HO

(A) (A)

100 mg 100 mg

Imp. H (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2-ol


HO

OH O

H N

MM 0027.11

(2RS)-1-(4-Ethenylphenoxy)-3-[(1-methylethyl)amino] propan-2-ol Imp. J (EP): 1-[2-Hydroxy3-[(1-methylethyl)amino]propoxy]-3-[4(2-methoxyethyl)phenoxy]propan-2-ol (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]phenoxy]3-[(1methylethyl)amino]propan-2-ol Imp. M (EP) as Dihydrochloride: 1,3-Bis[(1-methylethyl)amino]propan-2-ol Dihydrochloride Imp. N (EP): (2RS)-3-[(1-Methylethyl)amino]propane-1,2-diol Imp. O (EP): 1,1'[(1-Methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy]propan2-ol] 1-[4-(2-Methoxyethyl)phenoxy]-2,3-epoxypropane
O

OH O

H N

(A)

100 mg

MM 0027.12

OH O O O

OH

H N

(A)

50 mg

MM 0027.13

OH O O

H N

(A)

100 mg

MM 0027.28 MM 0027.16 MM 0027.03

H N

OH

H N

(A)
x 2 HCl

100 mg 100 mg 100 mg

OH HO

H N

(A) (A)

OH O O N

OH O O

MM 0027.02 MM 0027.17

(A) (A)

100 mg 100 mg

1-Chloro-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol
O

OH O Cl

MM 0027.18

4,4'-(2-Hydroxy-1,3-propandiyldioxy)bis[(2-methoxyethyl)benzene)]
O

OH O O O OH Cl
O

(A)

100 mg

MM 0027.22 MM 0027.26

3-Chloropropane-1,2-diol 1-[2-(2-Methoxyethyl)phenyoxy]-2,3-epoxypropane

OH

(B) (C)

100 mg 50 mg

Metronidazole
MM 0012.00 MM 0012.02 MM 0012.05 MM 0012.06 MM 0012.07 Metronidazole
O2N N N OH

(A) (B) (C) (A) (A)

500 mg 100 mg 100 mg 100 mg 100 mg

Imp. A (EP): 2-Methyl-4-nitroimidazole Imp. B (EP): 4-Nitroimidazole Imp. C (EP): 2-(4-Nitro-1H-imidazol-1-yl)ethanol Imp. D (EP): 2-(5-Nitro-1H-imidazol-1-yl)ethanol
O2 N

O 2N N
O2N

NH

NH N

N N

OH

O2 N N N

OH

MM 0012.01

Imp. E (EP): 2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethanol

O2N

N N

OH

(A)

100 mg

154

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Code Product Price
O2N N N O OH

Unit

MM 0012.09

Imp. G (EP): 2-(2-Methyl-5-nitro-1Himidazol-1-yl)acetic Acid 1-(2-Hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole (Hydroxymetronidazole)

(A)

100 mg

MM 0012.04

O2N N N

OH OH

(A)

100 mg

Metronidazole Benzoate
MM 0278.00 Metronidazole Benzoate
O2 N N N

(A)
O O

100 mg

MM 0012.00

Imp. A (EP): Metronidazole

O2N N N

OH

(A)

500 mg

MM 0012.02

Imp. B (EP): 2-Methyl-5-nitroimidazole (2-Methyl-4-nitroimidazole) Imp. C (EP): Benzoic Acid

O2N NH N

(B)

100 mg

MM 0278.01

O OH

(B)

100 mg

MM 0278.04

2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethyl Benzoate
O2 N N N O O

(A)

100 mg

Mevastatin
MM 0377.00 Mevastatin
O OH O O O

(A)

100 mg

Mexiletine Hydrochloride
MM 0146.00 Mexiletine Hydrochloride
NH2 O x HCl

(A)

500 mg

MM 0146.01

Imp. A (EP): 2,6-Dimethylphenol

OH

(A)

100 mg

MM 0146.02

Imp. B (EP): 1-(2,6-Dimethylphenoxy)propan-2-one

O O

(A)

100 mg

MM 0146.06

Imp. D (EP) as Hydrochloride: (2RS)-2-(2,6-Dimethylphenoxy)propan-1-amine Hydrochloride

(A)
NH2 x HCl

50 mg

Mianserin Hydrochloride
MM 0147.00 Mianserin Hydrochloride
N N x HCl

(A)

100 mg

MM 0147.01

Imp. A (EP): [2-[(2RS)-4-Methyl-2-phenylpiperazin-1-yl]phenyl]methanol

N N

(A)

100 mg

OH

MM 0147.04

Imp. C (EP): (2-Aminophenyl)methanol

H2N

(B)
OH

100 mg

New MM 0147.05

Imp. E (EP) as Hydrochloride: (14bRS)1,2,3,4,10,14b-Hexahydrodibenzo[c,f]pyrazino[1,2a]azepine Hydrochloride (Desmethylmianserin Hydrochloride)

HN N x HCl

(A)

50 mg

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Pharmaceutical impurities
Code Product Price
O N N

Unit

MM 0147.06

Mianserin N-Oxide

(D)

100 mg

Miconazole Nitrate
MM 0281.00 Miconazole Nitrate
Cl O Cl Cl N N Cl

(A)
x HNO3

500 mg

MM 0074.00

Miconazole
Cl O Cl Cl

Cl

(A)

250 mg

N N

MM 0281.01

Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2(1H-imidazol-1-yl)ethanol


Cl HO

Cl

(A)

100 mg

N N

MM 0524.00

Imp. B (EP) as Nitrate: 1-[(2RS)-2-[(4-Chlorobenzyl)oxy]2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate (Econazole Nitrate)

Cl

(A)
x HNO3

500 mg

Cl O Cl N N

MM 0281.03

Imp. C (EP) as Nitrate: (2RS)-2-[(2,4-Dichlorobenzyl)oxy]2-(2,4-dichlorophenyl)ethanamine Nitrate


Cl O Cl Cl

Cl

(D)
x HNO3 NH2

100 mg

MM 0541.00

Imp. D (EP) as Nitrate: 1-[(2RS)-2-[(2,6-Dichlorobenzyl)oxy]2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate (Isoconazole Nitrate)

Cl

(A)
x HNO3

100 mg

Cl

Cl O Cl N N

MM 0281.06

Imp. F (EP) as Nitrate: 1-[(2RS)2-[(3,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]1H-imidazole Nitrate

Cl

(A)
x HNO3

100 mg

Cl O Cl Cl N N Cl

MM 0281.07

Imp. G (EP) as Nitrate: 1-[(2RS)2-[(2,5-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]1H-imidazole Nitrate


Cl

(A)
x HNO3

100 mg

Cl O Cl N N

MM 0281.08

Imp. H (EP) as Nitrate: 1-[(2RS)-2-Benzyloxy2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate


Cl O

Cl

(A)
x HNO3 N N

100 mg

156

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Pharmaceutical impurities
Code Product Price
Cl

Unit

MM 0281.09

Imp. I (EP) as Nitrate: 1-[(2RS)-2-[(2-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate


Cl O Cl

(A)
x HNO3 N N

100 mg

MM 0281.10

1-(2,4-Dichlorobenzoylmethyl)imidazole
Cl O

Cl

(A)

100 mg

N N

Midazolam
New MM 1106.00 Midazolam [Controlled Substance]
N Cl N F N

(A)

100 mg

MM 0070.02

Imp. F (EP): 7-Chloro-5-(2-fluorophenyl)-1,3dihydro-2H-1,4-benzodiazepin-2-one (1-Des[(diethylamino)ethyl]flurazepam)

H N Cl N

(A)

100 mg

Minoxidil
MM 0521.00 Minoxidil
N N N NH2 NH2 O

(A)

500 mg

MM 0521.01

Imp. A (EP): 6-Chloropyrimidine-2,4-diamine 3-Oxide

Cl

N N NH2

NH2 O

(A)

100 mg

MM 0521.02

Imp. B (EP): 6-Chloropyrimidine-2,4-diamine

Cl

N N NH2

NH2

(C)

100 mg

MM 0521.05

Imp. E (EP): 6-(Piperidin-1-yl)pyrimidine-2,4-diamine (Desoxyminoxidil)

(A)
N N N NH2 NH2

100 mg

Mirtazapine
MM 1005.00 Mirtazapine
N N N

(A)

100 mg

MM 1005.02

Imp. A (EP): (14bRS)-2-Methyl-1,2,3,4,1014b-hexahydropyrazino[2,1-a]pyrido[2,3c][2]benzazepine 2-Oxide


N

(A)
O N N

100 mg

MM 1005.03

Imp. B (EP): [2-[(2RS)-4-Methyl-2-phenylpiperazin-1-yl]pyridin-3-yl]methanol


HO N N

(A)
N

100 mg

MM 1005.09

Imp. D (EP) as Maleate: (14bRS)-1,2,3,4,10,14bHexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine Maleate


N

O NH N x O OH OH

(A)

50 mg

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157

Pharmaceutical impurities
Code Product Price Unit

MM 1005.01

Imp. E (EP): (2RS)-4-Methyl-1-(3-methylpyridin-2-yl)-2-phenylpiperazine


N N

(A)
N

100 mg

MM 1005.07

1-Methyl-3-phenylpiperazine
N HN

(A)

100 mg

Moclobemide
MM 0250.00 Moclobemide
Cl O N H N O

(A)

100 mg

Modafinil
MM 540.01 Imp. A (EP): [(RS)-(Diphenylmethyl)sulfinyl]acetic Acid
O S O OH

(A)

50 mg

MM 0540.02

Imp. B (EP): 2-[(Diphenylmethyl)sulfonyl]acetamide

O O S

O NH2

(A)

50 mg

MM 0540.03

Imp. C (EP): Methyl [(RS)-(Diphenylmethyl)sulfinyl]acetate

O S

O O

(A)

50 mg

MM 0599.14

Bis(diphenylmethyl) Ether
O

(A)

50 mg

MM 0540.04

2-[(Diphenylmethyl)sulfenyl]acetamide
S

O NH2

(A)

50 mg

MM 540.06

Bis(diphenylmethyl)disulfide
S S

(A)

50 mg

Molsidomine
MM 0267.00 Molsidomine
O O N O NN+

(A)
N O

250 mg

MM 0267.02

Imp. A (EP) as Hydrochloride: 3-(Morpholin-4-yl)sydnonimine Hydrochloride (Linsidomine Hydrochloride) Imp. B (EP): 4-Nitrosomorpholine

O HN

NN+

(A)
N O x HCl

100 mg

MM 0267.03

O N N O

(A)

100 mg

MM 0267.01 MM 0267.06

Imp. C (EP): (2E)-(Morpholin-4-ylimino)acetonitrile Imp. E (EP): Morpholine

N O

(A) (A)
O

100 mg 100 mg

HN

158

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Code Product Price Unit

Mometasone Furoate
New MM 1272.00 Mometasone Furoate
HO O O O Cl O Cl O

(A)

100 mg

Montelukast Sodium
MM 0698.00 Montelukast Sodium
Cl N S HO O ONa

100 mg

Morphine Hydrochloride
MM 0037.00 Morphine Hydrochloride Trihydrate [Controlled Substance]
HO O N x H3 PO4 x H2O O O OH N HO O OH N x HCl x 3 H2O OH

(A)

250 mg

MM 0442.00

Imp. A (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance] Imp. B (EP): 7,7',8,8'-Tetradehydro-4,5:4',5'-diepoxy17,17'-dimethyl-2,2'-bimorphinanyl-3,3',6,6'-tetrol (Pseudomorphine; 2,2'-Bimorphine)

(A)

100 mg

MM 0037.01

(A)

100 mg

HO N

OH

MM 0037.03

Imp. F (EP): (17S)-7,8-Didehydro-4,5-epoxy-17methylmorphinan-3,6-diol17-Oxide (Morphine N-Oxide) [Controlled Substance]


HO

O N

(A)

100 mg

O N

OH

MM 0037.02

7,7',8,8'-Tetradehydro-4,5a:4',5'a-diepoxy-3,3'-dimethoxy17,17'-dimethyl-2,2'-bimorphinanyl-6a,6'a-diol (Codeine Dimer; Dimethyl Pseudomorphine)

(A)

100 mg

HO

O N

OH

New MM 0037.09

Morphine Anhydrate [Controlled Substance]

(A)

100 mg

HO

OH

Morphine Sulphate
MM 0280.00 Morphine Hemisulphate Pentahemihydrate [Controlled Substance]
HO O N x H2SO4 x 5 H2O OH
2

(A)

250 mg

MM 0442.00

Imp. A (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]


O O

N x H3 PO4 x H2O OH N HO O OH

(A)

100 mg

MM 0037.01

Imp. B (EP): 7,7',8,8'-Tetradehydro-4,5:4',5'-diepoxy17,17'-dimethyl-2,2'-bimorphinanyl-3,3',6,6'-tetrol (Pseudomorphine;2,2'-Bimorphine)

(A)

100 mg

HO N

OH

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Pharmaceutical impurities
Code Product Price
O N

Unit

MM 0037.03

Imp. F (EP): (17S)-7,8-Didehydro-4,5-epoxy17-methylmorphinan-3,6-diol 17-Oxide (Morphine N-Oxide) [Controlled Substance]


HO

(A)

100 mg

OH

Moxifloxacin Hydrochloride
MM 0885.00 Moxifloxacine Hydrochloride
HN H H O N F O O N OH x HCl

(D)

100 mg

Moxonidine
MM 1278.02 Imp. B (EP): N-(Imidazolidin-2-ylidene)-4,6dimethoxy-2-methylpyrimidin-5-amine (4-Methoxymoxonidine)
N N O O N

(A)
HN N H

100 mg

Mycophenolate Mofetil
MM 1001.00 Mycophenolate Mofetil
O O O OH O O N O

(D)

100 mg

MM 1001.05

Imp. E (EP): Methyl (4E)-6-(4-Hydroxy-6methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate Imp. F (EP): (4E)-6-(4-Hydroxy-6-methoxy-7methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)4-methylhex-4-enoic Acid (Mycophenolic Acid) Imp. G (EP): 2-(Morpholin-4-yl)ethyl (4E)-6-(4-Hydroxy-6-methoxy-7-methyl3-oxo-1,3-dihydroisobenzofuran-5-yl)4-methylhex-4-enoate N-Oxide Imp. H (EP): 7-Hydroxy-5-methoxy-4-methyl6-[2-[(2RS)-2-methyl-5-oxotetrahydrofuran-2yl]ethyl]isobenzofuran-1(3H)-one
O O OH

O O

OH O O O

(A)

100 mg

MM 1001.06

O O

OH OH O O

(A)

100 mg

MM 1001.07

O O O

O N O

(A)

100 mg

MM 1001.08

O O

OH O O

(A)
O

100 mg

Nabumetone
MM 0153.00 Nabumetone
O O

(A)

500 mg

MM 0153.02

Imp. A (EP): 3-(6-Methoxynaphthalen-2-yl)5-methylcyclohexanone


O

(A)

100 mg

MM 0153.03

Imp. B (EP): (5RS)-5-(6-Methoxynaphthalen-2-yl)3-methylcyclohex-2-enone


O

(A)

100 mg

MM 0153.04

Imp. C (EP): (2RS)-4-(6-Methoxynaphthalen-2-yl)butan-2-ol


O

OH

(A)

100 mg

MM 0153.05

Imp. D (EP): (E)-4-(6-Methoxynaphthalen-2-yl)but-3-en-2-one


O

(A)

100 mg

MM 0153.06

Imp. E (EP): 1,5-Bis(6-methoxynaphthalen2-yl)pentan-3-one


O

(A)
O
O

50 mg

MM 0153.07

Imp. F (EP): 6,6'-Dimethoxy-2,2'-binaphthalenyl


O

(A)

100 mg

160

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Code Product Price
OH O O

Unit

MM 0152.01

(6-Methoxy-2-naphthyl)acetic Acid ((6-Methoxynaphthalen2-yl)acetic Acid, -Demethylnaproxen)

(A)

100 mg

Nadolol
MM 0439.00 Nadolol
OH HO O OH H N

on request

and enantiomers

MM 0439.06

Imp. F (EP) as Hydrochloride: (2RS)-1-[(1,1Dimethylethyl)amino]-3-(naphthalen-1-yloxy)propan-2-ol Hydrochloride Imp. G (EP) as Hydrochloride: (2RS)-1-[(1,1Dimethylethyl)amino]-3-[(5,6,7,8-tetrahydronaphtalen-1-yl)oxy]-propan-2-ol Hydrochloride

OH O

H N

(A)
x HCl

50 mg

MM 0439.07

OH O

H N

(A)
x HCl

50 mg

Nafcillin Sodium
MM 0392.00 Nafcillin Sodium
O N O NH O H S O ONa

on request

MM 0392.02

Penilloic Acids of Nafcillin


O H N O

HO HN S

(D)

100 mg

MM 0392.04

2-Ethoxynaphthoic Acid

OH O

(B)

100 mg

Naftidrofuryl Hydrogen Oxalate


MM 0373.00 Naftidrofuryl Hydrogen Oxalate
O O O N x O OH O OH

(A)

500 mg

Naloxone Hydrochloride Dihydrate


MM 0272.00 Naloxone Hydrochloride Dihydrate
N OH x HCl x 2 H2O

(A)

250 mg

HO

Naltrexone
MM 0233.00 Naltrexone Hydrochloride
HO N x HCl

(A)

100 mg

HO

Nandrolone
MM 0660.00 Nandrolone
H OH

(A)

250 mg

MM 0660.01

19-Norandrost-4-ene-3,17-dione (Estr-4-ene-3,17-dione)
H

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Nandrolone Decanoate
MM 0982.00 Nandrolone Decanoate
O H O

(A)

100 mg

MM 0660.00

Imp. D (EP): 17-Hydroxyestr-4-en-3-one (Nandrolone)


O

OH H

(A)

250 mg

Naphazoline Hydrochloride
MM 0075.00 Naphazoline Hydrochloride
HN N x HCl

(A)

500 mg

MM 0075.06

Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)2-(naphthalen-1-yl)acetamide Hydrochloride (Naphthylacetylethylenediamine Hydrochloride) Imp. B (EP): (Naphthalen-1-yl)acetic Acid (1-Naphthylacetic Acid)

O N H NH2 x HCl

(A)

100 mg

MM 0075.02

O OH

(B)

100 mg

MM 0075.04

Imp. C (EP): (Naphthalen-1-yl)acetonitrile (1-Naphthylacetonitrile)

(B)

100 mg

New MM 0075.03

Imp. D (EP) as Hydrochloride: 2-(Naphthalen2-ylmethyl)-4,5-dihydro-1H-imidazole Hydrochloride (-Naphazoline Hydrochloride) Ethyl (1-Naphthyl)acetate

HN

N x HCl

(A)

50 mg

MM 0075.05

O O

(A)

100 mg

MM 0075.07

(Naphthalen-1-y)lacetamide (1-Naphthylacetamide)

O NH 2

(A)

100 mg

Naphazoline Nitrate
MM 0286.00 Naphazoline Nitrate
HN N x HNO 3

(A)

500 mg

MM 0075.06

Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)-2-(naphthalen-1-yl)acetamide Hydrochloride (Naphthylacetylethylenediamine Hydrochloride) Imp. B (EP): (Naphthalen-1-yl)acetic Acid (1-Naphthylacetic Acid)

O N H NH 2 x HCl

(A)

100 mg

MM 0075.02

O OH

(B)

100 mg

MM 0075.04

Imp. C (EP): (Naphthalen-1-yl)acetonitrile (1-Naphthylacetonitrile)

(B)

100 mg

MM 0075.05

Ethyl (1-Naphthyl)acetate

O O

(A)

100 mg

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Code Product Price
O NH2

Unit

MM 0075.07

(Naphthalen-1-yl)acetamide (1-Naphthylacetamide)

(A)

100 mg

Naproxen
MM 0152.00 Naproxen
O O OH

(A)

500 mg

MM 0152.06

Imp. A (EP): (2S)-2-(6-Hydroxynaphthalen-2-yl)propanoic Acid (O-Demethylnaproxen)


HO

OH O

(A)

100 mg

MM 0152.09

Imp. B (EP): (2S)-2-(5-Chloro-6-methoxynaphthalen-2-yl)propanoic Acid (5-Chloronaproxen) Imp. C (EP): (2S)-2-(5-Bromo-6-methoxynaphthalen-2-yl)propanoic Acid (5-Bromonaproxen) Imp. D (EP): (2S)-2-(5-Iodo-6-methoxynaphthalen-2-yl)propanoic Acid (5-Iodonaproxen) Imp. E (EP): Methyl (2S)-2-(6-Methoxynaphthalen-2-yl)propanoate (Naproxen Methyl Ester) Imp. F (EP): Ethyl (2S)-2-(6-Methoxynaphthalen-2-yl)propanoate (Naproxen Ethyl Ester) Imp. H (EP): 6-Methoxynaphthalen-2-ol (Hydroxynerolin) Imp. I (EP):(6-Methoxynaphthalen-2-yl)acetic Acid (-Demethylnaproxen) Imp. J (EP): 2-Ethyl-6-methoxynaphthalene (Ethylnerolin) Imp. K (EP): (1RS)-1-(6-Methoxynaphthalen-2-yl)ethanol

OH O Cl O

(A)

100 mg

MM 0152.10

OH O Br O

(A)

100 mg

MM 0152.11

OH O I O

(A)

100 mg

MM 0152.02

O O O

(A)

100 mg

MM 0152.12

O O O
OH O OH O O

(A)

100 mg

MM 0152.14 MM 0152.01 MM 0152.18 MM 0152.16

(A) (A) (A)

100 mg 100 mg 100 mg 100 mg

O OH

(A)

MM 0152.07

Imp. L (EP): 1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin)


O

(B)

100 mg

MM 0152.08 MM 0152.17 MM 0152.04

Imp. M (EP): 2-Methoxynaphthalene (Nerolin)


O

(B)
Br O

100 mg 100 mg 500 mg

Imp. N (EP): 2-Bromo-6-methoxynaphthalene Naproxen Sodium


O O
O

(C) (A)

ONa

MM 0152.15

2-Carboxy-6-methoxynaphthalene
O

(A)
OH

100 mg

Nateglinide
MM 0847.00 Nateglinide
H N O OH O

on request

MM 0847.03

Imp. B (Pharmeuropa): N-[[trans-4-(Propan2-yl)cyclohexyl]carbonyl]-L-phenylalanine


O

(A)
H N O OH

50 mg

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163

Pharmaceutical impurities
Code Product Price
O H2N OH

Unit

MM 0314.03

Imp. D Nateglinide (EP): Phenylalanine

(B)

100 mg

MM 0847.04

Imp. E (Pharmeuropa): N-[(trans-4-Ethylcyclohexyl)carbonyl]-D-phenylalanine (Nateglinide Ethyl Analog)


O

(A)
H N O OH

50 mg

MM 0847.09

Imp. F (EP) as Dicyclohexylammonium Salt: N-[[trans-4-(1-Methylethyl)cyclohexyl]carbonyl]D-phenylalanyl-D-phenylalanine Dicyclohexylammonium Salt (Nateglinide IPP Impurity Dicyclohexylammonium Salt)
x

(A)
H N O O N H OH O

50 mg

H N

MM 0847.06

Imp. G (Pharmeuropa): Ethyl N-[[trans-4-(Propan2-yl)cyclohexyl]carbonyl]-D-phenylalaninate (Nateglinide Ethyl Ester)


O

(A)
H N O O

50 mg

Nevirapine Anhydrous
MM 1146.01 Imp. A (EP): 11-Ethyl-4-methyl-5,11-dihydro6H-dipyrido [3,2-b:2',3'-e][1,4]diazepin-6-one
N N N

(A)

100 mg

NH O

MM 1146.02

Imp. B (EP): 4-Methyl-5,11-dihydro-6Hdipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one

H N

(A)

100 mg

NH O

MM 1146.03

Imp. C (EP): 4-Methyl-11-propyl-5,11-dihydro6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one

(D)
N N N

100 mg

NH O

MM 1146.04

3-Amino-2-chloro-4-methylpyridine

Cl H2N

(A)

100 mg

Nicardipine Hydrochloride
MM 0465.00 Nicardipine Hydrochloride
O O O NO2 H N O N x HCl

(A)

250 mg

MM 0465.01

3-Methyl 5-[Methyl(phenylmethyl)amino]ethyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine3,5-dicarboxylate Dihydrochloride

N O O O NO2 O N x 2 HCl

on request

Nicergoline
MM 0115.00 Nicergoline
N O H Br N O O
Cl N O O O N

(A)
N

100 mg

MM 0115.02

Imp. A (EP): [(6aR,9R,10aS)-10a-Methoxy4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl]methyl 5-Chloropyridine-3-carboxylate (Chloronicergoline)

H N

(D)

50 mg

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Code Product Price
H N O N OH

Unit

MM 0115.04

Imp. C (EP): [(6aR,9R,10aS)-10a-Methoxy-4,7-dimethyl4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin9-yl]methanol (Methylmethoxylumilysergol) Imp. D (EP): 5-Bromopyridine-3-carboxylic Acid

(D)

100 mg

MM 0115.06

Br

(B)
N

100 mg

HO O

MM 0115.03

5-Debromonicergoline
N

N O N O

on request

Nicorandil
MM 0924.00 Nicorandil
N O N H O NO 2

(A)

100 mg

Nicotinamide
MM 0552.00 Nicotinamide
N O NH2

(A)

500 mg

MM 0552.01

Isonicotinamide
N

O NH2

(A)

100 mg

Nicotine
MM 0517.00 Nicotine
N N

(A)

500 mg

MM 0517.03

Imp. C (EP): (5S)-1-Methyl-5-(pyridin-3-yl)pyrrolidin-2-one (Cotinine) Imp. G (EP): 3-[(2S)-Piperidin-2-yl]pyridine (Anabasine)

(A)
N N O

100 mg

MM 0517.01

(A)
N N H

100 mg

Nicotinic Acid
MM 0553.00 Nicotinic Acid
N O OH

(A)

500 mg

MM 0553.06

Imp. B (EP): 2,2'-Bipyridine-5,5'-dicarboxylic Acid (6,6'-Dinicotinic Acid)


HO O N

O N OH

(A)

100 mg

MM 0553.03

Imp. E (EP): Pyridine-4-carboxylic Acid (Isonicotinic Acid)


N

O OH

(A)

100 mg

MM 0549.00

Methyl Nicotinate
N

O O

(A)

500 mg

MM 0104.00

Benzyl Nicotinate
N

O O

(A)

500 mg

Nifedipine
MM 0003.00 Nifedipine
O O H N O O NO2

(A)

500 mg

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Pharmaceutical impurities
Code Product Price
N O O O O NO2

Unit

MM 0003.02

Imp. A (EP): Dimethyl 2,6-Dimethyl-4-(2-nitrophenylpyridine3,5-dicarboxylate (Nitrophenylpyridine Analogue of Nifedipine)

(A)

100 mg

MM 0003.01

Imp. B (EP): Dimethyl 2,6-Dimethyl-4-(2-nitrosophenylpyridine3,5-dicarboxylate (Nitrosophenylpyridine Analogue of Nifedipine)

N O O O O NO

(A)

100 mg

MM 0003.07

Imp. C (EP) as E/Z-Mixture: Methyl (E/Z)-2-(2-Nitrobenzylidene)3-oxobutanoate

O O O NO2

(A)

100 mg

MM 0003.08

Imp. D (EP): Methyl 3-Aminobut-2-enoate

H2N O O

(C)

100 mg

MM 0003.03

2-Nitrobenzaldehyde

O NO 2

(B)

100 mg

Niflumic Acid
MM 0850.00 Niflumic Acid
N O OH NH

(A)

250 mg

F F F

MM 0915.01

Imp. A (EP): 2-Chloropyridine-3-carboxylic Acid (2-Chloronicotinic Acid) Imp. B (EP): 2-Hydroxy-N-[3-(trifluoromethyl)phenyl]pyridine-3-carboxamide Imp. C (EP): 3-(Trifluoromethyl)aniline
N OH H N O

Cl OH O

(A)

100 mg

MM 0850.05

F F

(A)

100 mg

MM 0161.06

F F

(B)

100 mg

NH2

MM 0850.01

Imp. F (EP): Methyl 2-[[3-(Trifluoromethyl)phenyl]amino]pyridine-3-carboxylate (Niflumic Acid Methyl Ester)

F F

(A)

100 mg

NH O O

Nifuroxazide
MM 0574.00 Nifuroxazide
O 2N O N OH H N O

(A)

500 mg

MM 0574.01

Imp. A (EP): 4-Hydroxybenzohydrazide (p-Hydroxybenzohydrazide) Imp. B (EP): Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate) Imp. C (EP): (5-Nitrofuran-2-yl)methylidene Diacetate ((5-Nitrofuran-2-yl)methylene Diacetate)

OH H2N H N O

(C)

100 mg

MM 0431.00

OH O O

(A)

500 mg

MM 0943.02

O O O2N O O O

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Nifursol
MM 0444.00 Nifursol
OH O 2N O N H NO2 N O NO2

(A)

100 mg

MM 0444.01 MM 0444.02 MM 0444.03

5-Nitro-2-furfural 5-Nitrofurfural Hydrazone 3,5-Dinitrosalicylic Acid Hydrazide

O O H2N N OH O 2N NO2

(C) (A) (A)

100 mg 100 mg 100 mg

O O N H NO2

NO2

NH2

Nikethamide
MM 0627.00 Nikethamide
N O N

(A)

500 mg

Nimesulide
MM 0378.00 Nimesulide
O2 N H N S

(A)

250 mg

O O O

MM 0378.01

Imp. A (EP): N-(2,4-Dinitro-6-phenoxyphenyl) methanesulphonamide


O 2N

NO2 H N O O

(A)
S O

100 mg

MM 0378.02

Imp. B (EP): N-(2-Phenoxyphenyl)methanesulphonamide

H N O O

(A)
S O

100 mg

MM 0378.03

Imp. C (EP): 2-Phenoxyaniline

NH 2 O

(A)

100 mg

MM 0378.04

Imp. D (EP): 4-Nitro-2-phenoxyaniline


O2N

NH2 O

(A)

100 mg

MM 0378.05

Imp. E (EP): N,N-Bis(methylsulphonyl)-2phenoxyaniline

O O S S O O O N

(A)

100 mg

MM 0378.06

Imp. F (EP): N,N-Bis(methylsulphonyl)-4nitro-2-phenoxyaniline


O2 N

O O S S O O O N

(A)

100 mg

MM 0378.07

Imp. G (EP): 4-Nitro-2-phenoxyphenol


O 2N

OH O

(A)

50 mg

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167

Pharmaceutical impurities
Code Product Price Unit

Nimodipine
MM 0416.00 Nimodipine
O O O NO 2 H N O O

(A)

100 mg

MM 0416.01

Imp. A (EP): 2-Methoxyethyl 1-Methylethyl 2,6Dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate

N O O O NO 2 O O

(A)

100 mg

MM 0416.02

Imp. B (EP): Bis(1-methylethyl) 2,6-Dimethyl-4(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

H N O O O NO2 O

(A)

100 mg

MM 0416.03

Imp. C (EP): Bis(2-methoxyethyl) 2,6-Dimethyl4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate


O

H N O O O NO2 O O

(A)

100 mg

Nitrazepam
MM 0078.00 Nitrazepam [Controlled Substance]
O2N H N N O

(A)

100 mg

MM 0078.02

Imp. A (EP): 3-Amino-6-nitro-4-phenylquinolin-2(1H)-one


O2N

H N

O NH2

(A)

100 mg

MM 0078.01

Imp. B (EP): (2-Amino-5-nitrophenyl)phenylmethanone (2-Amino-5-nitrobenzophenone)

NH2 O2N O

(B)

100 mg

MM 0078.03

Imp. C (EP): 2-Bromo-N-[4-nitro-2-(phenylcarbonyl)phenyl]acetamide


O2 N

O NH O

Br

(A)

50 mg

MM 0078.05

Imp. D (EP): 2-(1,3-Dioxo-1,3-dihydro-2Hisoindol-2-yl)-N-[4-nitro-2-(phenylcarbonyl)phenyl]acetamide


O2 N

O O NH O N

(A)

50 mg

MM 0078.07

7-Aminonitrazepam
H 2N

H N N

(A)

100 mg

Nitrendipine
MM 0092.00 Nitrendipine
O O O NO 2 H N O

(A)

500 mg

MM 0092.03

Imp. A (EP): Ethyl Methyl 2,6-Dimethyl-4(3-nitrophenyl)pyridine-3,5-dicarboxylate (Photolysis Product)

N O O O NO 2 O

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
H N O O O NO 2 O

Unit

MM 0092.01

Imp. B (EP): Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)1,4-dihydropyridine-3,5-dicarboxylate

(A)

100 mg

MM 0092.02

Imp. C (EP): Diethyl 2,6-Dimethyl-4-(3-nitrophenyl)1,4-dihydropyridine-3,5-dicarboxylate

H N O O O NO2 O

(A)

100 mg

MM 0092.04

1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5dicarboxylic Acid Methyl Ester

H N O O O NO2 OH

(A)

50 mg

MM 0092.05

1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5dicarboxylic Acid Ethyl Ester

H N O O O NO2 OH

(A)

50 mg

Nitrofural
MM 0943.00 MM 0943.02 Nitrofural Imp. B (EP): (5-Nitrofuran-2-yl)methylene Diacetate
O O2 N O O O

O2N

H N O

NH2

(A) (A)

500 mg 100 mg

Nitrofurantoin
MM 0506.00 Nitrofurantoin
O 2N O O N N H N O

(A)

500 mg

Nizatidine
MM 0220.00 Nizatidine
N S N S N H N H NO2 NO2

(A)

500 mg

MM 0220.01

Imp. A (EP): N,N-Dimethyl-2-nitroethene-1,1-diamine


N H

(A)

100 mg

N H NO2

MM 0220.09

Imp. B (EP): (EZ)-N-Methyl-1-methylsulphanyl)-2nitroethen-1-amine


S

(A)

100 mg

N H NO2

MM 0220.02

Imp. C (EP): (EZ)-N-[2-[[[2-[(Dimethylamino)methyl]thiazol4-yl]methyl]sulphinyl]ethyl]-N-methyl-2-nitroethene1,1-diamine Imp. D (EP) as Dioxalate: 2-[[[2-[(Dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethanamine Dioxalate Imp. G (EP): N,N'-Bis[2-[[[2-[(dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-2nitroethene-1,1-diamine
N N S
N S

N S N O S N H

(C)

50 mg

N H
O O

MM 0220.04

HO N S NH2 x2 HO

(A)

50 mg

MM 0220.10

N NO2 N H N H S N

(A)
S

50 mg

MM 0220.11 New MM 0220.06

Imp. H (EP) as Hydrochloride: 2-(Dimethylamino) thioacetamide Hydrochloride Imp. I (EP): N-[2-[[[2-[(Dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-N'-methylurea


N S N

S N x HCl NH2

(A) (A)

100 mg 50 mg

O S N H N H

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Pharmaceutical impurities
Code Product Price
S N N N H OH

Unit

MM 0086.07

Imp. K (EP): 3-(Methylamino)-5,6-dihydro-2H1,4-thiazin-2-one Oxime

(A)

100 mg

Nonivamide
MM 1033.00 Nonivamide
O O HO N H
O HO

(A)

500 mg

MM 1033.01 MM 1033.02

4-(Aminomethyl)-2-methoxyphenol Hydrochloride (Vanillylamine Hydrochloride) N-[(4-Hydroxy-3-methoxyphenyl)methyl]octanamide (N-Vanillyloctanamide) N-[(4-Hydroxy-3-methoxyphenyl)methyl]decanamide (N-Vanillyldecanamide) N,O-Dinonanoylvanillylamine


O HO

NH 2

x HCl

(A) (A)

100 mg 100 mg

O N H O O HO N H O O O O N H

MM 1033.03

(A)

100 mg

MM 1033.04

(A)

100 mg

Noradrenaline Tartrate
MM 0614.02 Imp. A (EP): Adrenaline (L-Adrenaline)
OH HO HO H N

(A)

500 mg

MM 0384.00

Imp. C (EP) as Hydrochloride: Dopamine Hydrochloride

HO HO

NH2 x HCl

(A)

500 mg

Norethisterone
MM 0218.00 Norethisterone
OH

(A)

250 mg

MM 0218.04

Imp. A (EP): 17-Hydroxy-19-nor-17-pregna4,6-dien-20-yn-3-one (6,7-Didehydronorethisterone)


O

OH

(D)

100 mg

MM 0660.01

Imp. B (EP): Estr-4-ene-3,17-dione (Norandrostenedione)

(A)

100 mg

MM 0218.01

Imp. H (EP): 6,17-Dihydroxy-19-nor-17-pregn4-en-20-yn-3-one (6-Hydroxynorethisterone)


O OH

OH

(D)

100 mg

MM 0218.02

6-Hydroxynorethisterone

OH

(D)

50 mg

O OH

MM 0218.03

6-Ketonorethisterone

OH

(D)

100 mg

O O

Norethisterone Acetate
MM 0219.00 Norethisterone Acetate
O O

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
OH

Unit

MM 0218.00

Imp. A (EP): Norethisterone

(A)

250 mg

MM 0219.10

Imp. B (EP): 3-Oxo-19-nor-17-pregn-5(10)en-20-yn-17-yl Acetate

O O

on request

MM 0219.01

Imp. F (EP): 6-Hydroxy-3-oxo-19-nor-17pregn-4-en-20-yn-17-yl Acetate (6-Hydroxynorethisterone Acetate)


O OH

O O

(D)

100 mg

MM 0219.03

Imp. G (EP): 3,6-Dioxo-19-nor-17-pregn4-en-20-yn-17-yl Acetate (6-Ketonorethisterone Acetate)


O O

O O

(D)

100 mg

MM 0219.02

6-Hydroxynorethisterone Acetate
O

(D)

50 mg

O OH

MM 0219.04

6,7-Didehydronorethisterone Acetate
O

(D)

100 mg

Norfenefrine Hydrochloride
MM 0973.00 Norfenefrine Hydrochloride
OH HO NH 2 x HCl

(A)

500 mg

Norfloxacin
MM 0350.00 Norfloxacin
HN N F O O N OH

(A)

250 mg

MM 0350.01

Imp. A (EP): 7-Chloro-1-ethyl-6-fluoro-4-oxo1,4-dihydroquinoline-3-carboxylic Acid

(A)
Cl F O O N OH

100 mg

MM 0350.03

Imp. D (EP): 1-Ethyl-6-fluoro-7-(piperazin-1-yl) quinolin-4(1H)-one

HN N F O N

(D)

100 mg

MM 0350.04

Imp. G (EP): 1-Ethyl-6-fluoro-7-(4-formyl-piperazin-1-yl)4-oxo-1,4-dihydroquinoline-3-carboxylic Acid

N N F O O N OH

(D)

100 mg

Nortriptyline Hydrochloride
MM 0079.00 Nortriptyline Hydrochloride
x HCl N H

(A)

500 mg

MM 0062.01

Imp. A (EP): 10,11-Dihydro-5H-dibenzo[a,d][7] annulen-5-one (Dibenzosuberone)


O

(B)

100 mg

MM 0079.01

Imp. B (EP) as Hydrochloride: 3-(5H-Dibenzo[a,d][7]annulen-5-ylidene)-N-methylpropan-1amine Hydrochloride (Norcyclobenzaprine Hydrochloride)

(A)
N H x HCl

50 mg

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171

Pharmaceutical impurities
Code Product Price
N OH

Unit

MM 0062.03

Imp. D (EP): 5-[3-(Dimethyl-amino)propyl]10,11-dihydro-5H-dibenzo-[a,d][7]annulen-5-ol

(A)

100 mg

MM 0062.02

Imp. E (EP) as Hydrochloride: 3-(5HDibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-amine Hydrochloride (Cyclobenzaprine Hydrochloride) Imp. F (EP) as Hydrochloride: Amitriptyline Hydrochloride

(A)
N x HCl

100 mg

MM 0062.00

(A)
N x HCl

500 mg

MM 0062.12

Imp. J (EP) as Hydrochloride: [3-(10,11Dihydro-5H-dibenzo[a,d][7]annulen5-ylidene)propyl]-dimethylamine Oxide Hydrochloride (Amitriptyline N-Oxide Hydrochloride)

O N x HCl

(B)

10 mg

Nucleosides
MM 1316.01 Cytidine
N HO O O OH OH NH2 N HO O O OH N N NH2

(A)

100 mg

MM 1316.02

2'-Deoxycytidine

(A)

100 mg

Ofloxacin
MM 0228.00 Ofloxacin
N N F O O O N OH

(A)

500 mg

MM 0228.04

Imp. A (EP): (RS)-9,10-Difluoro-3-methyl-7-oxo2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6carboxylic Acid (FPA) Imp. B (EP): (RS)-9-Fluoro-3-methyl-10-(4methylpiperazin-1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazin-7-one Imp. E (EP): (RS)-9-Fluoro-3-methyl-7-oxo-10-(piperazin1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine6-carboxylic Acid Imp. F (EP) as Hydrochloride: 4-[(RS)-6-Carboxy9-fluoro-3-methyl-7-oxo-2,3-dihydro-7Hpyrido[1,2,3-de]-1,4-benzoxazine-10-yl]1-methylpiperazine 1-Oxide Hydrochloride (Ofloxacin N-Oxide Hydrochloride)

O F F O O
O N F O N

(A)
N OH

100 mg

MM 0228.05

(A)

100 mg

MM 0228.08

HN N F

O N OH O O

(A)

100 mg

MM 0228.10

N N F

O N x HCl OH O O

(A)

100 mg

Olanzapine
MM 0329.00 Olanzapine
N HN S N N

on request

172

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Pharmaceutical impurities
Code Product Price
N

Unit

MM 0329.08

Imp. A (EP): 5-Methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile


O2 N HN

(A)

50 mg

MM 0329.02

Imp. B (EP): 2-Methyl-5,10-dihydro-4Hthieno[2,3-b][1,5]benzodiazepin-4-one (Olanzapine Lactame) Imp. C (EP): 1-(Chloromethyl)-1-methyl-4-(2methyl-10H-thieno[2,3-b][1,5]benzodiazepin4-yl)piperazin-1-ium Chloride (Olanzapine-N-Chloromethyl Chloride) Imp. D (EP): 1-Methyl-4-(2-methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-yl)piperazin-1-oxide (Olanzapine N-Oxide)
HN S

H N HN S

(A)

50 mg

MM 0329.07

Cl N+ N HN S N Cl-

(A)

100 mg

MM 0329.03

O N N N

(A)

50 mg

Omeprazole
MM 0095.00 Omeprazole
H N S O N O H N SH O N N O

(A)

500 mg

MM 0095.03 MM 0095.04

Imp. A (EP): 5-Methoxy-1H-benzimidazole-2-thiol Imp. B (EP): 2-[(RS)-[(3,5-Dimethylpyridin -2-yl)methyl]sulphinyl]-5-methoxy-1Hbenzimidazole Imp. C (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin2-yl)methyl]sulphanyl]-1H-benzimidazole (Ufiprazole)
O

(A) (A)

100 mg 100 mg

H N O N S O N

MM 0095.06

O H N S N O H N O N S N O O N

(A)

100 mg

MM 0095.05

Imp. D (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin2-yl) methyl]sulphonyl]-1H-benzimidazole (Omeprazole Sulphone) Imp. E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy-1Hbenzimidazol-2-yl)sulphinyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole N-Oxide) Imp. F (EP): 8-Methoxy-1,3-dimethyl12-thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol2(12H)-one Imp. G (EP): 9-Methoxy-1,3-dimethyl12-thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol2(12H)-one Imp. H (EP): 2-[(RS)-[(4-Chloro-3,5-dimethylpyridin2-yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole
O
O

(A)

100 mg

MM 0095.07

NH N S O O N O

(A)

100 mg

MM 0095.01

S N N
O N N N S O

(D)
N O

50 mg

MM 0095.02

(D)

50 mg

MM 0095.15

NH N S O N Cl

(D)

100 mg

MM 0095.16

Imp. I (EP): 4-Methoxy-2-[[(5-methoxy-1H-benzimidazol2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide) 5-Methoxy-2-[[(3,5-dimethylpyridin-2-yl)methyl] sulphanyl]-1H-benzimidazole

O N

NH S O O N O NH N S N O

(A)

100 mg

MM 0095.08

(A)

100 mg

MM 0095.19

5-Methoxy-2-[[(4-chloro-3,5-dimethylpyridin-2-yl) methyl]sulphanyl]-1H-benzimidazole

O N

NH S N Cl

(D)

100 mg

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173

Pharmaceutical impurities
Code Product Price
O N H NH O

Unit

MM 0095.20

5-Methoxy-1,3-dihydrobenzimidazol-2-one

(A)

100 mg

MM 0095.23

2-[[(4-Methoxy-3,5-dimethylpyridin-2-yl)methyl] sulphinyl]-1H-benzimidazole
N

NH S O N O

(A)

100 mg

MM 0095.24

5-Methoxy-2-(4-methoxy-3,5-dimethylpyridin-2-yl)-1Hbenzimidazole

O N

NH O N

(A)

100 mg

Ondansetron Hydrochloride Dihydrate


MM 0252.00 Ondansetron Hydrochloride Dihydrate
N N O N

(A)
x HCl x 2 H2 O

100 mg

MM 0252.09

Ondansetron

N N O

(A)

100 mg

MM 0252.03

Imp. A (EP): (3RS)-3-(Dimethylamino)methyl9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one Imp. B (EP): 6,6'-Methylene bis[(3RS)9-methyl-3-[(2-methyl-1H-imidazol1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol4-one] Imp. C (EP): 9-Methyl-1,2,3,9-tetrahydro-4Hcarbazol-4-one Imp. D (EP): 9-Methyl-3-methylene-1,2,3,9tetrahydro-4H-carbazol-4-one Imp. E (EP): 1H-Imidazole (Imidazole)

N N O

(A)

100 mg

MM 0252.02

(D)

50 mg

MM 0252.01

(A)
O

100 mg

MM 0252.04

(A)
O

100 mg

MM 0015.02 MM 0252.06 MM 0252.07

N N H

(B) (B) (A)

100 mg 100 mg 100 mg

Imp. F (EP): 2-Methyl-1H-imidazole


N H

Imp. G (EP): (3RS)-3-[(1H-Imidazol-1-yl)methyl]-9methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one (C-Demethylondansetron) Imp. H (EP): (3RS)-3-[(2-Methyl-1H-imidazol-1-yl) methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one (N-Demethylondansetron)

N N O
H N N O

MM 0252.08

(A)

100 mg

Opipramol Dihydrochloride
MM 0422.01 5-(3-Piperazin-1-yl-propyl)-5H-dibenzo[b,f]azepine Dihydrochloride (A)
N N NH x 2 HCl

100 mg

Ornidazole
MM 0948.00 Ornidazole
O2 N N N OH
O2 N NH N

(A)
Cl

500 mg

MM 0012.02

2-Methyl-4-nitroimidazole

(B)

100 mg

MM 0948.02

3-(2-Methyl-5-nitro-1H-imidazol-1-yl)propane-1,2-diol

O2 N N N OH OH

(A)

100 mg

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Code Product Price
O2 N N N O

Unit

MM 0948.03

3-(2-Methyl-5-nitro-1H-imidazol-1-yl)-1,2-epoxypropane

(A)

100 mg

MM 0948.04

1-(3-Chloro-2-hydroxypropyl)-2-methyl-4-nitroimidazole

O2 N N

N OH

Cl

(A)

100 mg

Orphenadrine Hydrochloride
MM 0801.00 Orphenadrine Hydrochloride
O N x HCl

(A)

500 mg

MM 0801.01

Imp. A (EP): (RS)-(2-Methylphenyl)phenylmethanol (2-Methylbenzhydrol)


OH

(A)

100 mg

MM 0801.02

Imp. B (EP): (2-Methylphenyl)phenylmethanone (2-Methylbenzophenone)


O

(A)

100 mg

MM 0801.03

Imp. C (EP) as Hydrochloride: (RS)-2-[(2-Methylphenyl)phenylmethoxy]ethanamine Hydrochloride


O NH2

(A)
x HCl

50 mg

MM 0490.00

Imp. D (EP) as Hydrochloride: Diphenhydramine Hydrochloride


O N

(A)
x HCl

500 mg

MM 0801.05

Imp. E (EP) as Hydrochloride: (RS)-N,N-Dimethyl2-[(3-methylphenyl)phenylmethoxy]ethanamine Hydrochloride (meta-Methylbenzyl Isomer Hydrochloride)


O

(A)
N x HCl

100 mg

MM 0490.04

Imp. F (EP) as Hydrochloride: (RS)-N,N-Dimethyl2-[(4-methylphenyl)phenylmethoxy]ethanamine Hydrochloride (para-Methylbenzyl Isomer Hydrochloride; 4-Methyldiphenhydramine Hydrochloride) N-Desmethylorphenadrine Hydrochloride

(A)
O N x HCl

100 mg

MM 0801.07

(A)
O H N x HCl

100 mg

Oxacillin Sodium
MM 0686.00 Oxacillin Sodium Monohydrate
O O N O N H N S H x H 2O O ONa

(A)

250 mg

MM 0026.04

Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2carboxylic Acid (6-Aminopenicillanic Acid) Imp. E (EP) as Sodium Salt Monohydrate: Cloxacillin Sodium Monohydrate
Cl O N O O H N N

O O N H2N S H

OH

(B)

100 mg

MM 0682.00

ONa x H2O

(A)

500 mg

S H

Oxalic Acid Dihydrate


MM 0928.00 Oxalic Acid Dihydrate
O O OH x 2 H2O OH

(A)

500 mg

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175

Pharmaceutical impurities
Code Product Price
O O OH OH

Unit

MM 0928.01

Oxalic Acid

(A)

500 mg

Oxaliplatin
MM 0928.00 Imp. A (EP) as Dihydrate: Ethanedioic Acid Dihydrate (Oxalic Acid Dihydrate)
O O OH x 2 H2O OH

(A)

500 mg

Oxazepam
MM 0080.00 Oxazepam [Controlled Substance]
Cl H N N O OH

(D)

100 mg

MM 0028.03

Imp. D (EP): (2-Amino-5-chlorophenyl)phenylmethanone (2-Amino-5-chlorobenzophenone)

NH2 Cl O

(B)

100 mg

MM 0028.02

Imp. E (EP): 7-Chloro-5-phenyl-1,3-dihydro2H-1,4-benzodiazepin-2-one 4-Oxide (Demoxepam)

H N Cl N

(A)

100 mg

MM 0080.03

6-Chloro-4-phenyl-3,4-dihydroquinazoline-2carboxylic Acid
Cl

O N NH OH

(A)

100 mg

Oxcarbazepine
MM 0076.17 Oxcarbazepine
O

(A)
N

100 mg

NH2

MM 0076.10

10-Hydroxy-10,11-dihydrocarbamazepine

HO

(A)
N

100 mg

NH2

Oxeladin Hydrogen Citrate


MM 0547.00 Oxeladin Hydrogen Citrate
O O O N x OH OH O O OH O OH

(A)

500 mg

MM 0547.02 MM 0547.01

Imp. A (EP): 2-[2-(Diethylamino)ethoxy]ethanol Oxeladin N-Oxide

HO

(A) (B)

100 mg 10 mg

O O O N O

Oxfendazole
MM 0518.02 Imp. B (EP): Methyl [5-(Phenylsulphonyl)1H-benzimidazol-2-yl]carbamate (Fenbendazole Sulphone)
H N S O O N O O NH

(A)

100 mg

Oxiracetam
New MM 1406.00 Oxiracetam
HO O N O NH2

(A)

250 mg

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Pharmaceutical impurities
Code Product Price Unit

Oxolinic Acid
MM 0898.00 Oxolinic Acid
O O O O N OH

(A)

250 mg

Oxomemazine
MM 0957.00 Oxomemazine
N S O O N

(A)

100 mg

MM 0958.00

Trimeprazine Tartrate
N S

N x HO O 2

OH

O OH

(A)

500 mg

OH

MM 0958.02

Trimeprazine Sulphoxide Hydrochloride


N S O

N x HCl

(A)

100 mg

MM 0958.04

Oxomemazine N-Oxide Hydrochloride (Trimeprazine Sulphone N-Oxide Hydrochloride)


N S O O

(A)
x HCl

100 mg

Oxprenolol Hydrochloride
MM 0129.00 Oxprenolol Hydrochloride
OH O O H N

(A)
x HCl

500 mg

MM 0129.01

1-(2-Hydroxyphenoxy)-3-(isopropylamino)-2-propanol Hydrochloride

OH O OH

H N

(A)
x HCl

50 mg

Oxybuprocaine Hydrochloride
MM 0543.00 Oxybuprocaine Hydrochloride
H2N O O O N x HCl

(A)

500 mg

MM 0094.03

Imp. A (EP): 4-Aminobenzoic Acid


H2 N

O OH

(B)

100 mg

MM 0543.02

Imp. B (EP): 4-Amino-3-butoxybenzoic Acid


H2N O

O OH

(A)

100 mg

MM 0543.03

Imp. C (EP): 4-Amino-3-hydroxybenzoic Acid


H2N OH

O OH

(A)

100 mg

MM 0543.05

Oxybuprocaine N-Oxide Dihydrochloride


H2N O

O O N O x 2 HCl

(A)

100 mg

Oxybutynin Hydrochloride
MM 0047.00 Oxybutynin Hydrochloride
O O OH N x HCl

(A)

250 mg

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177

Pharmaceutical impurities
Code Product Price Unit

MM 0047.06

Imp. B (EP): 4-(Diethylamino)but-2-ynyl 2-Hydroxy-2,2-diphenylacetate (Diphenyl analogue of Oxybutynin) Imp. C (EP) as Hydrochloride: 4-(Ethylmethylamino)but2-ynyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride (Methylethyl analogue of Oxybutynin Hydrochloride) Imp. D (EP): (RS)-2-Cyclohexyl-2-hydroxy2-phenylacetic Acid (Phenylcyclohexylglycolic Acid)

(A)
HO O O N

100 mg

MM 0047.04

(D)
HO O O N x HCl

100 mg

MM 0047.01

(A)
HO OH O

100 mg

MM 0047.07

Imp. E (EP): 4-(Ethylpropylamino)but-2-ynyl (RS)2-Cyclohexyl-2-hydroxy-2-phenylacetate (Ethylpropyl analogue of Oxybutynin) Methyl (RS)-2-Cyclohexyl-2-hydroxy-2phenylacetate (Phenylcyclohexylglycolic Acid Methyl Ester) 4-Diethylaminobut-2-yn-1-ol Desethyloxybutynin Hydrochloride
HO

(A)
HO O O N

100 mg

MM 0047.02

O O OH

(A)

100 mg

MM 0047.03 MM 0047.11

HO

(A) (D)

100 mg 100 mg

O O

N H

x HCl

MM 0047.50

Propargyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate (Phenylcyclohexylglycolic Acid Propargyl Ester)

(B)
HO O O

10 mg

Oxycodone Hydrochloride
MM 0672.00 Oxycodone Hydrochloride [Controlled Substance]
N HO x HCl

(A)

100 mg

O
N HO

New MM 0672.10

Oxycodone [Controlled Substance]

(A)

100 mg

MM 0672.03

Imp. C (EP) as Hydrochloride: 4,5-Epoxy-14hydroxy-3-methoxymorphinan-6-one Hydrochloride (Noroxycodone Hydrochloride)


O

H N HO x HCl

(D)

50 mg

MM 0672.05

4,5-Epoxy-3-methoxy-17-methylmorphinan6,14-diol Hydrochloride
O

N HO x HCl

on request

OH
O N

MM 0672.06

Oxycodone N-Oxide

(D)

50 mg

HO

Oxymetazoline Hydrochloride
MM 0177.00 Oxymetazoline Hydrochloride
HO HN N

(A)
x HCl

250 mg

MM 0177.01

Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)2-[4-(1,1-dimethylethyl)-3-hydroxy2,6-dimethylphenyl)]acetamide Hydrochloride

HO O

H N

(A)
NH2 x HCl

100 mg

178

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Code Product Price Unit

MM 0089.00

Imp. B (EP) as Hydrochloride: Xylometazoline Hydrochloride Imp. C (EP): 2-[4-(1,1-Dimethylethyl)-3hydroxy-2,6-dimethylphenyl]acetamide

(A)
N N H x HCl

500 mg

MM 0177.07

OH O NH2

(A)

100 mg

MM 0177.04

Imp. D (EP): [4-(1,1-Dimethylethyl)-3hydroxy-2,6-dimethylphenyl]acetic Acid

OH O OH

(A)

100 mg

MM 0177.05

Imp. E (EP): [4-(1,1-Dimethylethyl)-3hydroxy-2,6-dimethylphenyl]acetonitrile

OH N

(D)

100 mg

Oxymorphone Hydrochloride Monohydrate


New MM 0673.00 Oxymorphone Hydrochloride Monohydrate [Controlled Substance]
N HO x HC x H2O

(A)

100 mg

HO

O
H N HO x HCl

New MM 0673.03

Noroxymorphone Hydrochloride

(A)

100 mg

HO

Oxyphenbutazone
MM 0933.00 Oxyphenbutazone Monohydrate
OH O N N O x H2O

(A)

250 mg

Oxytetracycline Hydrochloride
MM 0554.00 Oxytetracycline Hydrochloride
OH O H HO OH O OH H OH O H HO N O NH2 OH N x HCl O NH2 OH x HCl

(A)

500 mg

MM 0452.00

Imp. B (EP) as Hydrochloride: Tetracycline Hydrochloride

OH

OH O OH H

(A)

500 mg

Pantoprazole Sodium Sesquihydrate


MM 0099.00 Pantoprazole Sodium
F F N O NNa S O N O O

(D)

100 mg

MM 0099.01

Pantoprazole
F

O F N

NH S O N

O O

(D)

100 mg

MM 0099.02

Imp. A (EP): 5-(Difluoromethoxy)-2-[[(3,4dimethoxypyridin-2-yl)methyl]sulphonyl]1H-benzimidazole (Pantoprazole Sulphone)

O F F N

NH

(A)
O S O O O N

100 mg

MM 0099.03

Imp. B (EP): 5-(Difluoromethoxy)-2-[[(3,4dimethoxypyridin-2-yl)methyl]sulphanyl]1H-benzimidazole Imp. C (EP): 5-(Difluoromethoxy)-1Hbenzimidazole-2-thiol

O F F N

NH S N

O O

(A)

100 mg

MM 0099.04

O F F N

NH SH

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
O F F F O F N N S O N
O Cl N O x HCl

Unit

MM 0099.11

Mixture of Imp. D and F (EP): 5- and 6-(Difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin2-yl)methyl]sulphinyl]-1-methyl-1H-benzimidazole

N N S O + N

O O

(D)

100 mg

O O

MM 0099.05

2-Chloromethyl-3,4-dimethoxypyridine Hydrochloride

(A)

100 mg

MM 0099.06

Pantoprazole N-Oxide
F

O F N

NH S O O N

O O

(D)

100 mg

MM 0099.07

Pantoprazole Sulphone N-Oxide


F

O F N

NH S O O N O

O O

(A)

100 mg

Paracetamol
MM 0042.00 MM 0042.08 Paracetamol
HO H N O

(A) (B)
O

500 mg 100 mg

Imp. A (EP): N-(2-Hydroxyphenyl)acetamide (2-Acetamidophenol) Imp. B (EP): N-(4-Hydroxyphenyl)propanamide (N-Propionyl-4-aminophenol) Imp. C (EP): N-(3-Chloro-4-hydroxyphenyl)acetamide (3-Chloro-4-hydroxyacetanilide) Imp. D (EP): N-Phenylacetamide (Acetanilide) Imp. E (EP): 1-(4-Hydroxyphenyl)ethanone (4-Hydroxyacetophenone)
HO

OH

H N

MM 0042.05 MM 0042.09

H N HO O

(A) (A)
O
H N O

100 mg 100 mg

Cl HO

H N

MM 0042.10 MM 0042.11

(B)
O

100 mg 100 mg

(B)

MM 0042.03 MM 0042.12

Imp. F (EP): 4-Nitrophenol


HO

NO 2

(B) (A)

100 mg 100 mg

Imp. G (EP): 1-(4-Hydroxyphenyl)ethanone Oxime (4-Hydroxyacetophenone Oxime)


HO

HO

MM 0042.04 MM 0042.13

Imp. H (EP): 4-(Acetylamino)phenyl Acetate (N,O-Diacetyl-4-aminophenol) Imp. I (EP): 1-(2-Hydroxyphenyl)ethanone (2-Hydroxyacetophenone) Imp. J (EP): N-(4-Chlorophenyl)acetamide (4-Chloroacetanilide) Imp. K (EP): 4-Aminophenol

O O

H N O O

(A) (B)

100 mg 100 mg

OH

MM 0042.02 MM 0042.01 MM 0042.07

H N Cl O NH2 HO

(B) (B) (B)

100 mg 100 mg 100 mg

3-Aminophenol

HO

NH2

Paroxetine Hydrochloride Anhydrous


New MM 1032.01 Imp. A (EP) as Hydrochloride: (3S,4R)-3-[(1,3Benzodioxol-5-yloxy)methyl]-4-phenylpiperidine Hydrochloride (Desfluoroparoxetine Hydrochloride) (A)
O O O NH x HCl

50 mg

180

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Pharmaceutical impurities
Code Product Price
O O OH

Unit

MM 1032.02 MM 1032.07

Imp. B (EP): 1,3-Benzodioxol-5-ol (Sesamol) Imp. G (EP) as Hydrochloride: 4-(4-Fluorophenyl)1-methyl-1,2,3,6-tetrahydropyridine Hydrochloride [(3S,4R)-4-(4-Fluorophenyl)-1-methylpiperidin-3-yl] methanol
F

(A) (A)

100 mg 100 mg

x HCl N

MM 1032.12

(A)
HO N

100 mg

Paroxetine Hydrochloride Hemihydrate


New MM 0264.00 Paroxetine Hydrochloride Hemihydrate
O O F x HCl x 1/2 H2O

(A)
O NH

100 mg

Pentetrazol
MM 0692.00 Pentetrazol
N N N N

(A)

500 mg

Pentobarbital
New MM 1357.00 Pentobarbital [Controlled Substance]
O H N O NH O

(A)

100 mg

Pentobarbital Sodium
New MM 1368.00 Pentobarbital Sodium [Controlled Substance]
O H N N O ONa

(A)

100 mg

Pentoxifylline
MM 0761.00 Pentoxifylline
O N O N O N N

(A)

500 mg

MM 0577.00

Imp. A (EP): Theobromine


HN O

O N N
O HN O N O N O N O N O N N N H N N H N N

(A)
N

500 mg

MM 0176.03

Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine2,6-dione (3-Methylxanthine)

(A)

100 mg

MM 0176.00

Imp. C (EP): Theophylline

(A)

500 mg

MM 0494.00

Imp. F (EP): Caffeine

(A)

500 mg

Pentoxyverine Hydrogen Citrate


MM 1268.01 Imp. A (EP): 1-Phenylcyclopentanecarboxylic Acid
O OH

(A)

100 mg

Peppermint Oil
MM 0388.00 (-)-Menthol (Levomenthol)
OH

(A)

500 mg

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181

Pharmaceutical impurities
Code Product Price Unit

MM 0163.12

(+)-(R)-Pulegone
O

(A)

100 mg

Perazine Dimaleate
MM 0815.00 Perazine Dimaleate
N N S x 2 N HO HO O O

(A)

100 mg

Perazine Dimalonate
MM 0157.00 Perazine Dimalonate
N N S x2 O HO
N N N S O

N O OH

on request

MM 0157.01

Perazine Sulphoxide

(A)

100 mg

MM 0157.02 MM 0157.03

Phenothiazine 1-(3-Chloropropyl)-4-methylpiperazine
Cl

H N S N N

(B)

100 mg on request

Perphenazine
MM 0826.00 Perphenazine
N S Cl N N OH

(A)

100 mg

MM 0826.01

Imp. A (EP): 2-[4-[3-(2-Chloro-5-oxido-10Hphenothiazin-10-yl)propyl]piperazin-1-yl]ethanol (Perphenazine Sulphoxide)


O

(A)
N S Cl N N OH

100 mg

MM 0826.02

Imp. B (EP): 2-[4-[3-(10H-Phenothiazin-10yl)propyl]piperazin-1-yl]ethanol


S

(A)
N N N OH

50 mg

Pethidine Hydrochloride
New MM 0315.00 Pethidine Hydrochloride [Controlled Substance]
O O
N

N x HCl

(A)

100 mg

New MM 0315.13

Prepethidine [Controlled Substance]


N

(A)

100 mg

New MM 0315.04

Imp. D (EP): Methyl 1-Methyl-4-phenylpiperidine-4-carboxylate [Controlled Substance] Imp. E (EP): Ethyl 4-Phenylpiperidine-4carboxylate [Controlled Substance]

(A)

100 mg

O NH

New MM 0315.05

(A)

100 mg

Phenazepam
New MM 0828.00 Phenazepam
Br H N N Cl O

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Phenacetin
MM 0551.00 Phenacetin
O H N O H N HO O

(A)

100 mg

MM 0042.00 MM 0042.01

Paracetamol 4-Aminophenol
HO

(A)
NH2

500 mg 100 mg

(B)

Phenethyl Alcohol
MM 0953.00 Phenylethyl Alcohol
OH

(A)

500 mg

Pheniramine Maleate
MM 0059.00 Pheniramine Maleate
N N x O O OH OH

(A)

100 mg

MM 0059.02

Imp. A (EP): 2-Benzylpyridine

(C)

100 mg

MM 0059.03

Imp. B (EP): 4-Benzylpyridine

(C)

100 mg

MM 0059.09

Imp. C (EP) as Sesquifumarate: (3RS)-N,NDimethyl-3-phenyl-3-(pyridin-4-yl)propan1-amine Sesquifumarate

N N x 1,5 HO O

O OH

(A)

100 mg

MM 0059.08

Imp. D (EP) as Dihydrochloride: N,N,N',N'Tetramethyl-3-phenyl-3-(pyridin-2-yl)pentane1,5-diamine Dihydrochloride

N x 2 HCl N

(D)

100 mg

MM 0059.01

Pheniramine

N N

(A)

100 mg

MM 0059.05

Pheniramine N-Oxide Dihydrochloride

N N

O x 2 HCl

(A)

100 mg

MM 0059.06

Norpheniramine Maleate

H N x

O OH OH O

(A)

100 mg

Phentolamine Mesilate
MM 0171.04 Imp. B (EP) as Hydrochloride: 2-(Chloromethyl)4,5-dihydro-1H-imidazole Hydrochloride
Cl N N H x HCl

(A)

100 mg

Phenobarbital
MM 0265.07 Imp. B (EP): (5RS)-5-Ethyl-6-imino-5phenyldihydropyrimidine-2,4(1H,3H)dione
HN H N O NH O

(A)

50 mg

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183

Pharmaceutical impurities
Code Product Price
O H N O NH O

Unit

MM 0265.08

Imp. C (EP): 5-Methyl-5-phenylpyrimidine2,4,6(1H,3H,5H)-trione

(A)

50 mg

MM 0265.01

Phenylethylacetylurea (2-Phenylbutyrylurea)

O N H

O NH2

(A)

100 mg

MM 0265.02

N-Benzoyl-N'-(2-phenyl)butanoylurea

O N H

O N H

(A)

100 mg

MM 0265.03

Barbituric Acid

H N

O NH

(C)

100 mg

Phenoxyethanol
MM 0952.00 Phenoxyethanol
O OH

(A)

500 mg

Phenoxymethylpenicillin Potassium
MM 0026.00 Phenoxymethylpenicillin Potassium
O H N O N S H
O O H N O N S H OK

OK

(A)

250 mg

MM 0160.00

Imp. A (EP) as Potassium Salt: Benzylpenicillin Potassium

(A)

250 mg

MM 0026.03

Imp. B (EP): Phenoxyacetic Acid


O O OH

(B)

100 mg

MM 0026.04

Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) Imp. D (EP): (2S,5R,6R)-3,3-Dimethyl-7-oxo6-[[2-(4-hydroxyphenoxy)acetyl]amino]-4-thia1-azabicyclo[3.2.0]heptane-2-carboxylic Acid (4-Hydroxyphenoxymethylpenicillin) Imp. E (EP): (4S)-2-[Carboxy[(phenoxyacetyl) amino]methyl]-5,5-dimethylthiazolidine-4carboxylic Acid (Penicilloic Acids of Phenoxymethylpenicillin) Imp. F (EP): (2RS,4S)-5,5-Dimethyl-2[[(phenoxyacetyl)amino]methyl]thiazolidine4-carboxylic Acid (Penilloic Acids of Phenoxymethylpenicillin)

O O N H 2N S H

OH

(B)

100 mg

MM 0026.02

O HO O O O H N N S H
O HN S OH
O HN S O O NH

OH

(A)

100 mg

MM 0026.01

OH

(A)

100 mg

O O

H N O

MM 0026.05

OH

(A)

100 mg

Phenylbutazone
MM 0548.00 Phenylbutazone
N N O O

(A)

500 mg

MM 0548.01

Imp. A (EP): (2RS)-2-[(1,2-Diphenyldiazanyl)carbonyl]hexanoic Acid

O N NH O OH

(D)

100 mg

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Pharmaceutical impurities
Code Product Price
O N N O OH

Unit

MM 0548.02

Imp. B (EP): 4-Butyl-4-hydroxy-1,2diphenylpyrazolidine-3,5-dione

(A)

50 mg

MM 0548.03

Imp. C (EP): 1,2-Diphenyldiazane (1,2-Diphenylhydrazine) Imp. D (EP): 1,2-Diphenyldiazene

H N

(A)
N H

100 mg

MM 0548.04

(C)
N N

100 mg

MM 0548.05

Imp. E (EP) as Dihydrochloride: Biphenyl-4,4'diamine Dihydrochloride (Benzidine Dihydrochloride)

H2N

NH2

x 2 HCl

(A)

100 mg

Phenylephrine Hydrochloride
MM 0081.00 Phenylephrine Hydrochloride
OH HO H N

(A)
x HCl

500 mg

MM 0081.03

Imp. C (EP) as Hydrochloride: 1-(3-Hydroxyphenyl)2-(methylamino)ethanone Hydrochloride (Phenylephrone Hydrochloride) Imp. E (EP) as Hydrochloride: 2-(Benzylmethylamino)-1-(3-hydroxyphenyl)ethanone Hydrochloride (Benzylphenylephrone Hydrochloride) 1,2,3,4-Tetrahydro-4,6-dihydroxy-2methylisoquinoline Hydrochloride 1,2,3,4-Tetrahydro-4,8-dihydroxy-2methylisoquinoline Hydrochloride
HO

O HO

H N

(D)
x HCl

100 mg

MM 0081.08

O N x HCl

(D)

100 mg

MM 0081.05

OH HO N OH x HCl x HCl

(A)

100 mg

MM 0081.06

(A)

50 mg

N OH

Phenylpropanolamine Hydrochloride
MM 0656.00 Phenylpropanolamine Hydrochloride [Drug Precursor]
OH NH2 x HCl

(A)

500 mg

and enatiomere

Phenyltoloxamine Citrate
MM 0770.00 Phenyltoloxamine Citrate
O N x O OH OH O OH OH O

(A)

500 mg

Phenytoin
MM 0630.00 Phenytoin
H N

(A)
O NH

500 mg

MM 0630.01

Imp. A (EP): Diphenylmethanone (Benzophenone)


O

(B)

100 mg

MM 0630.02

Imp. B (EP): Diphenylethanedione (Benzil)

(B)
O

100 mg

MM 0630.04

Imp. C (EP): Amino(diphenyl)acetic Acid (2,2-Diphenylglycine)


NH2 OH O

(A)

100 mg

New MM 0630.05

Imp. D (EP): 3a,6a-Diphenyltetrahydroimidazo[4,5-d]imidazole2,5(1H, 3H)-dione

O HN HN NH O NH

(A)

50 mg

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185

Pharmaceutical impurities
Code Product Price
O HN NH2 OH O

Unit

MM 0630.06

Imp. E (EP): (Carbamoylamino)(diphenyl)acetic Acid

(A)

50 mg

MM 0630.08

Imp. F (EP): 5-(4-Methylphenyl)-5-phenylimidazolidine2,4-dione

H N

O NH

(A)

100 mg

MM 0630.07

1-Methyl-5,5-diphenylimidazolidine-2,4-dione
N

O NH

(D)

100 mg

MM 0630.03

5-(4-Methylphenyl)hydantoin

H N

O NH

(A)

100 mg

Phenytoin Sodium
MM 0622.00 Phenytoin Sodium
H N N O ONa

(A)

500 mg

MM 0630.01

Imp. A (EP): Diphenylmethanone (Benzophenone)


O

(B)

100 mg

MM 0630.02

Imp. B (EP): Diphenylethanedione (Benzil)


O

(B)

100 mg

MM 0630.04

Imp. C (EP): Amino(diphenyl)acetic Acid (2,2-Diphenylglycine)

(A)
NH2 OH O

100 mg

MM 0630.08

Imp. F (EP): 5-(4-Methylphenyl)-5phenylimidazolidine-2,4-dione

H N

O NH

(A)

100 mg

MM 0630.07

1-Methyl-5,5-diphenylimidazolidine-2,4-dione
N

O NH

(D)

100 mg

MM 0630.03

5-(4-Methylphenyl)hydantoin

H N

O NH

(A)

100 mg

Pholcodine
MM 0037.00 Imp. A (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]
HO O N x HCl x 3 H 2O OH

(A)

250 mg

MM 0280.00

Imp. A (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]


HO O

N x H2SO4 x 5 H2O OH 2
N x H3PO4 x 1/2 H2O O

(A)

250 mg

MM 0442.00

Imp. B (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]


O

(A)

100 mg

OH

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Pharmaceutical impurities
Code Product Price
N x H2O

Unit

MM 0004.00

Imp. B (EP) as Monohydrate: Codeine Monohydrate [Controlled Substance]

(A)

100 mg

OH

Pilocarpine Hydrochloride
MM 0338.00 Pilocarpine Hydrochloride
N N O O x HCl

(A)

500 mg

MM 0338.01

Imp. A (EP) as Hydrochloride: (3R,4R)-3-Ethyl-4[(1-methyl-1H-imidazol-5-yl)methyl]dihydrofuran2(3H)-one Hydrochloride (Isopilocarpine Hydrochloride) Imp. B (EP) as Sodium Salt: (2S,3R)-2-Ethyl-3(hydroxymethyl)-4-(1-methyl-1H-imidazol-5yl)butanoic Acid Sodium Salt (Pilocarpic Acid Sodium Salt) Imp. C (EP) as Sodium Salt: (2R,3R)-2-Ethyl-3(hydroxymethyl)-4-(1-methyl-1H-imidazol-5yl)butanoic Acid Sodium Salt (Isopilocarpic Acid Sodium Salt)

N N

O x HCl

(A)

100 mg

MM 0338.02

N N

OH O ONa

(A)

100 mg

MM 0338.03

N N

OH O ONa

(A)

100 mg

Pindolol
MM 0082.00 Pindolol
O OH N H N H

(A)

250 mg

MM 0082.08

Imp. B (EP): 1-[4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]-1H-indol-1-yl]-3-[(1methylethyl)amino]propan-2-ol Imp. C (EP): 1,1'-[(1-Methylethyl)imino]bis[3(1H-indol-4-yloxy)propan-2-ol] Imp. D (EP): (2RS)-3-(1H-Indol-4-yloxy) propane-1,2-diol Imp. E (EP): 1H-Indol-4-ol
HN

H N

OH N O

OH

H N

(D)

100 mg

MM 0082.06

OH O N

OH O NH

(A)

100 mg

MM 0082.02

OH HN O OH

(A)

100 mg

MM 0082.01

OH

(A)

100 mg

N H

New MM 0082.04

Imp. F (EP): (2RS)-1-Chloro-3(1H-indol-4-yloxy)propan-2-ol

OH HN O Cl

(A)

50 mg

Pioglitazone Hydrochloride
MM 0616.06 Imp. C (Pharmeuropa): (5RS)-5-[4-[2(5-Ethylpyridin-2-yl)ethoxy]benzyl]-3[2-(5-ethylpyridin-2-yl)ethyl]-1,3thiazolidine-2,4-dione Imp. E (Pharmeuropa): Ethyl 3-[4-[2-(5Ethylpyridin-2-yl)ethoxy]phenyl]propanoate 5-[4-[2-(5-Ethylpyridin-2-yl)ethoxy]benzyl]2-iminothiazolidin-4-one
N O O S N O N

(A)

50 mg

MM 0616.08

O O O

(A)

50 mg

MM 0616.04

NH S NH O

(A)

100 mg

Pipazetate Hydrochloride
MM 0486.06 MM 0486.02 Bis-(2-piperidinoethyl)ether Dihydrochloride (BPEE Dihydrochloride) 1,2-Dipiperidinoethane (DPE)
N N

x 2 HCl

(A) (A)

100 mg 100 mg

MM 0486.05

2-(2-Piperidinoethoxy)ethanol Hydrochloride

HO

x HCl

(A)

100 mg

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187

Pharmaceutical impurities
Code Product Price Unit

Pipemidic Acid Trihydrate


MM 0401.00 Pipemidic Acid Trihydrate
HN N N O O N N OH x 3 H2O

(A)

250 mg

Pipenzolate Bromide
MM 0783.00 Pipenzolate Bromide
N+ O OH O Br-

(A)

500 mg

MM 0630.01

Diphenylmethanone (Benzophenone)
O

(B)

100 mg

MM 0783.09

Benzilic Acid
HO

(B)
OH

100 mg

Piperacillin
MM 0295.00 Piperacillin
O O N N NH O O H N O N S H O

(A)
OH

100 mg

Piperacillin Sodium
MM 0296.00 Piperacillin Sodium
O O N N NH O O H N O N S H NaO O NH 2 H N N S H NaO

(A)
O

100 mg

MM 0253.00

Imp. A (EP) as Sodium Salt: Ampicillin Sodium

(A)

500 mg

MM 0296.05

Imp. E (EP): 1-Ethylpiperazine-2,3-dione


O

N NH O

(A)

100 mg

MM 0296.07

Imp. G (EP): (2R)-2-[[(4-Ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]-2-phenylacetic Acid

N O O N NH OH O O

(A)

100 mg

MM 0026.04

Imp. H (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)

O O H2 N N H S

OH

(B)

100 mg

Pipradrol Hydrochloride
New MM 1099.00 Pipradrol Hydrochloride [Controlled Substance]
NH OH x HCl

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Piprinhydrinate
MM 0155.00 Piprinhydrinate
O N O N N O H N Cl N

on request

MM 0155.01

Diphenylpyraline
O N

(A)

100 mg

MM 0155.02

8-Chlorotheophylline
N O

H N Cl N

(B)

100 mg

MM 0490.02

Diphenylmethanol (Benzhydrol)
OH

(B)

100 mg

Piracetam
MM 0083.00 Piracetam
N O O NH2

(A)

500 mg

MM 0083.05 MM 0083.04 MM 0083.02 MM 0083.01 MM 0083.03 MM 0083.06

Imp. A (EP): Pyrrolidin-2-one (2-Pyrrolidone)


O

NH

(B) (A)

100 mg 100 mg 100 mg 100 mg 100 mg 100 mg

Imp. B (EP): Methyl (2-Oxopyrrolidin-1-yl)acetate


O

O N O

Imp. C (EP): Ethyl (2-Oxopyrrolidin-1-yl)acetate


O

O N O

(A) (A)
OH

Imp. D (EP): (2-Oxopyrrolidin-1-yl)acetic Acid


O

O N

N-Vinyl-2-pyrrolidone
O

(A) (C)
NH2

2-Chloroacetamide

O Cl

Piroxicam
MM 0084.00 Piroxicam
O S O N H N N

(A)

500 mg

OH O

MM 0084.01 MM 0084.08

Imp. A (EP): Pyridin-2-amine (2-Pyridylamine) Imp. B (EP): 4-Hydroxy-N-(pyridin-2-yl)-2H-1,2benzothiazine-3-carboxamide 1,1-Dioxide


O S O NH

NH2

(B) (A)

100 mg 100 mg

H N O

OH

MM 0084.09

Imp. C (EP): 4-Hydroxy-2-methyl-2H-1,2benzothiazine-3-carboxamide1,1-Dioxide Imp. D (EP): Methyl (1,1-Dioxido-3-oxo-1,2benzisothiazol-2(3H)-yl)acetate Imp. E (EP): Ethyl (1,1-Dioxido-3-oxo-1,2benzisothiazol-2(3H)-yl)acetate Imp. F (EP): 1-Methylethyl (1,1-Dioxido-3-oxo1,2-benzisothiazol-2(3H)-yl)acetate

O N NH2

(A)

100 mg

OH O

MM 0084.07

O O S N O O O

(A)

100 mg

MM 0084.05

O O S N O O O

(A)

100 mg

MM 0084.10

O O S N O O O

(A)

100 mg

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189

Pharmaceutical impurities
Code Product Price
O S O NH O OH O

Unit

MM 0084.04

Imp. G (EP): Methyl 4-Hydroxy- 2H-1,2benzothiazine-3-carboxylate 1,1-Dioxide Imp. H (EP): Ethyl 4-Hydroxy- 2H-1,2benzothiazine-3-carboxylate 1,1-Dioxide Imp. I (EP): 1-Methylethyl 4-Hydroxy-2H1,2-benzothiazine-3-carboxylate 1,1-Dioxide Imp. J (EP): Methyl 4-Hydroxy-2-methyl-2H1,2-benzothiazine-3-carboxylate 1,1-Dioxide Imp. K (EP): Ethyl 4-Hydroxy-2-methyl-2H1,2-benzothiazine-3-carboxylate 1,1-Dioxide Imp. L (EP): 1-Methylethyl 4-Hydroxy-2-methyl-2H1,2-benzothiazine-3-carboxylate 1,1-Dioxide N-(2-Pyridinyl)oxamic Acid
O O

(A)

100 mg

MM 0084.06

O NH O

(A)

100 mg

OH O

MM 0084.11

O NH O

(A)

100 mg

OH O

MM 0084.02

O N O

(A)

100 mg

OH O

MM 0084.03

O N O

(A)

100 mg

OH O

MM 0084.12

O N O

(A)

100 mg

OH O

New MM 0084.14

H N O

O OH

(A)

100 mg

MM 0084.13

N-Methylsaccharin

O O S N O

(A)

100 mg

MM 0084.15

4-Isopropoxy-2-methyl-N-(2-pyridinyl)-2H1,2-benzothiazine-3-carboxamide 1,1-Dioxide

O N O H N N

(A)

100 mg

MM 0084.16

N,N'-Di-(2-pyridinyl)oxamide
N

H N O

O N H N

(C)

50 mg

MM 0084.17

N-(2-Pyridinyl)oxamic Acid Hydrochloride

H N O

O OH x HCl

on request

MM 0084.20

2-(1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetamide

O O S N O O NH2

(A)

100 mg

MM 0084.21

N-(6-Methyl-2-pyridyl)-4-hydroxy-2-methyl-2H1,2-benzothiazine-3-carboxamide-1,1-Dioxide

O N H N N

(B)

10 mg

OH O

MM 0084.22

4-Methoxy-2-methyl-N-(2-pyridyl)-2H-1,2benzothiazine-3-carboxamide-1,1-Dioxide

O N O
O N O O O NH NH2 OH O H N N

(C)
H N N

10 mg

MM 0084.23

2-Methyl-N-2-(1-methylpyridinium)-2H-1,2benzothiazine-3-carboxamide-4-olate 1,1-Dioxide 4-Hydroxy-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide

(B)

10 mg

MM 0084.24

(B)

10 mg

Potassium Sorbate
MM 0955.00 Potassium Sorbate
O OK

(A)

500 mg

Povidone
MM 0083.03 Imp. A (EP): 1-Ethenylpyrrolidin-2-one (1-Vinylpyrrolidin-2-one, N-Vinyl-2-pyrrolidone) (A)
N O

100 mg

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Pharmaceutical impurities
Code Product Price
H N O

Unit

MM 0083.05 MM 0537.01

Imp. B (EP): Pyrrolidin-2-one (2-Pyrrolidone) Vinyl Acetate

(B) (B)

100 mg 100 mg

O O

Pralidoxime Methyl Sulphate


MM 0689.00 Pralidoxime Methyl Sulphate
N N OH O O S O O

(A)

100 mg

MM 0689.01

2-Carboxy-N-methylpyridinium Iodide

O N OH I-

(A)

100 mg

MM 0689.02

2-Carbamoyl-N-methylpyridinium Methanesulfonate

O N NH2 O O S O

(A)

100 mg

Prasterone
MM 0651.00 Prasterone
O

(A)

500 mg

HO

MM 0651.02

16-Dehydropregnenolone Acetate Oxime


O O

N OH

(A)

100 mg

Pravastatin Sodium
MM 0503.00 Pravastatin Sodium
OH H O ONa OH O O

(A)

100 mg

OH

MM 0503.04

Imp. D (EP): (1S,3S,7S,8S,8aR)-3-Hydroxy-8-[2-[(2R,4R)4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Pravastatin Lactone)

O O H OH O O

(D)

100 mg

OH

Prazepam
New MM 1258.00 Prazepam [Controlled Substance]
N Cl N O

(A)

100 mg

MM 0023.02

Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro2H-1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance]

H N Cl N

(A)

100 mg

MM 0028.03

Imp. C (EP): (2-Amino-5-chlorophenyl)phenylmethanone

NH2 Cl O

(B)

100 mg

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191

Pharmaceutical impurities
Code Product Price Unit

Praziquantel
MM 0615.00 Praziquantel
O N N H O

(A)

250 mg

MM 0615.02

Imp. B (EP): 2-(Cyclohexylcarbonyl)2,3,6,7-tetrahydro-4H-pyrazino[2,1-a]isoquinolin-4-one

O N N O

on request

Prazosin Hydrochloride
MM 0085.00 Prazosin Hydrochloride
N O O N N NH2 N O x HCl O

(A)

100 mg

MM 0085.04

Imp. A (EP): 2-Chloro-6,7-dimethoxyquinazoline4-amine Imp. B (EP): 1,4-Bis(furan-2-ylcarbonyl)piperazine


O

O O

N N NH2

Cl

(A)

100 mg

MM 0085.05

O N N O O

(A)

100 mg

MM 0085.01

Imp. C (EP): 6,7-Dimethoxy-2-(piperazin-1-yl)quinazolin4-amine

NH O O N N NH2 N

(A)

100 mg

MM 0085.02

Imp. D (EP): 1-(Furan-2-ylcarbonyl)piperazine


N HN

(A)
O

100 mg

MM 0085.03

Imp. E (EP): 2,2'-(Piperazin-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine)


N O O N N NH2 N

NH2 N N O O

(D)

100 mg

MM 0085.06

2,4-Dichloro-6,7-dimethoxyquinazoline

O O

N N Cl

Cl

(A)

100 mg

MM 0085.07

6,7-Dimethoxyquinazoline-2,4(1H,3H)-dione

O O

H N NH O

(C)

100 mg

Prednisolone
MM 0193.00 Prednisolone
HO O OH OH

(A)

500 mg

MM 0185.00

Imp. A (EP): Hydrocortisone


HO

O OH OH

(A)

500 mg

MM 0482.00

Imp. B (EP): 17,21-Dihydroxypregna-1,4diene-3,11,20-trione (Prednisone)

O O OH OH

(A)

250 mg

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Pharmaceutical impurities
Code Product Price
O HO O OH O

Unit

MM 0194.00

Imp. C (EP): 11,17-Dihydroxy-3,20-dioxo-pregna1,4-dien-21-yl Acetate (Prednisolone Acetate)

(A)

500 mg

MM 0193.01

(20R)-Hydroxyprednisolone
HO

HO OH OH

(C)

10 mg

MM 0193.02

(20S)-Hydroxyprednisolone
HO

HO OH OH

(D)

50 mg

Prednisolone Acetate
MM 0194.00 Prednisolone Acetate
HO O O O OH

(A)

500 mg

MM 0187.00

Imp. A (EP): Hydrocortisone Acetate


HO

O O O OH

(A)

500 mg

MM 0193.00

Imp. B (EP): Prednisolone


HO

O OH OH

(A)

500 mg

MM 0194.04

Prednisolone 17-Acetate
HO

O O OH O O

(C)

50 mg

MM 0194.07

Prednienic Acid
HO

OH OH

(A)

100 mg

Prednisolone Pivalate
MM 0304.00 Prednisolone Pivalate
HO O OH O O

(D)

250 mg

Prednisolone Sodium Phosphate


MM 0305.00 Prednisolone Sodium Phosphate
HO O OH O O P ONa ONa

(A)

100 mg

Prednisolone Sodium Sulfobenzoate


MM 0484.01 Sodium 3-Sulfobenzoate
HO O O O S ONa

(C)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Prednisone
MM 0482.00 Prednisone
O O OH OH

(A)

250 mg

Prednisone Acetate
MM 0196.00 Prednisone Acetate
O O O O OH

(A)

250 mg

Pregabalin
New MM 1376.00 New MM 1376.01 Pregabalin rac-Pregabalin
NH2 O OH NH2 O OH

(A) (A)

100 mg 100 mg

Prilocaine Hydrochloride
MM 0563.00 Prilocaine Hydrochloride
H N O

(A)
N H x HCl

500 mg

MM 0563.01

Imp. A (EP): (RS)-2-Chloro-N-(2-methylphenyl)Propanamide Imp. B (EP): 2-Methylbenzenamine (o-Toluidine) Imp. C (EP) as Hydrochloride: (RS)-2-EthylaminoN-(2-methylphenyl)propanamide Hydrochloride Imp. D (EP) as Hydrochloride: (RS)-N-(3-Methylphenyl)-2-(propylamino)propanamide Hydrochloride
H N O
H N O N H

H N O

(A)
Cl

100 mg

MM 0563.02 MM 0563.03

NH2

(A) (A)

100 mg 50 mg

x HCl

MM 0563.04

(A)
N H x HCl

50 mg

MM 0563.05

Imp. E (EP) as Hydrochloride: (RS)-N-(4-Methylphenyl)2-(propylamino)propanamide Hydrochloride

H N O

(A)
N H x HCl

50 mg

Primidone
MM 1030.01 Imp. A (EP) as Hydrate: 2-Ethyl-2-phenylpropanediamide Hydrate (Ethylphenylmalonamide Hydrate)
O NH2 NH2 O x H 2O

(A)

100 mg

MM 1030.03

Imp. C (EP): (2RS)-2-Phenylbutanamide


NH2 O

(A)

100 mg

MM 1030.04

Imp. D (EP): (2RS)-2-Cyano-2-phenylbutanamide

N NH2 O

(A)

50 mg

MM 1030.05

Imp. E (EP): (2RS)-2-Phenylbutanoic Acid


OH O

(A)

100 mg

Probenecid
MM 0657.00 Probenecid
N S O O O OH

(A)

500 mg

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Pharmaceutical impurities
Code Product Price Unit

Procainamide Hydrochloride
MM 0550.00 Procainamide Hydrochloride
H2 N O N H N x HCl

(A)

500 mg

MM 0550.02

Procainamide N-Oxide Dihydrochloride


H2N

O N H N

O x 2 HCl

(A)

100 mg

Procaine Hydrochloride
MM 0596.00 Procaine Hydrochloride
H2N O O N x HCl

(A)

500 mg

MM 0094.03

4-Aminobenzoic Acid
H2N

O OH

(B)

100 mg

New MM 0550.03

N-Acetylprocainamide
O N H

O N H N

(A)

100 mg

Progesterone
MM 0222.00 Progesterone
O

(A)

500 mg

MM 0222.03

Imp. C (EP): (20R)-20-Hydroxypregn-4-en-3-one

HO

(A)

100 mg

MM 0222.01

Imp. E (EP): (20R)-3-Oxopregn-4-en-20-yl Acetate

O O

(D)

100 mg

MM 0222.08

11-Hydroxyprogesterone
HO

(A)

100 mg

MM 0222.12

11-Ketoprogesterone
O

(A)

100 mg

MM 0222.14

Pregnanediol (5-Pregnane-3,20(S)-diol)

HO

(A)

100 mg

HO

H HO OH

MM 0222.15

Pregnanetriol (5-Pregnane-3,17,20(S)-triol)

on request

HO

Proguanil Hydrochloride
MM 0162.05 Imp. B (EP): 4-Chloroaniline
Cl NH2

(B)

100 mg

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195

Pharmaceutical impurities
Code Product Price Unit

Prolintane Hydrochloride
MM 0663.00 Prolintane Hydrochloride
N x HCl

(A)

100 mg

Promazine Hydrochloride
MM 0290.00 Promazine Hydrochloride
N S N x HCl

(A)

500 mg

MM 0290.01

Imp. A (EP): 3-(10H-Phenothiazin-10-yl)-N,Ndimethylpropan-1-amine S-Oxide (Promazine Sulphoxide)

N N S O

(A)

100 mg

MM 0290.02 MM 0157.02

N,N-Dimethyl-3-chloropropylamine Hydrochloride Phenothiazine

Cl

N H N S

x HCl

(B) (B)

100 mg 100 mg

Promethazine Hydrochloride
MM 0412.00 Promethazine Hydrochloride
N S N x HCl

(A)

500 mg

MM 0157.02

Imp. A (EP): Phenothiazine


NH S

(B)

100 mg

MM 0412.02

Imp. B (EP) as Hydrochloride: (2RS)-N,NDimethyl-2-(10H-phenothiazin-10-yl)propan1-amine Hydrochloride (Isopromethazine Hydrochloride) Imp. C (EP) as Hydrochloride: (2RS)-N-Methyl1-(10H-phenothiazin-10-yl)propan-2-amine Hydrochloride (Norpromethazine Hydrochloride) Imp. D (EP): (2RS)-N,N-Dimethyl-1-(10H-phenothiazin10-yl)propan-2-amine S-Oxide (Promethazine Sulphoxide)

(A)
N S N x HCl

100 mg

MM 0412.03

N S

H N x HCl

(A)

50 mg

MM 0412.04

(A)
N O S N

100 mg

MM 0412.05

Promethazine Sulphoxide N-Oxide Hydrochloride


N O S N

O x HCl

(A)

100 mg

MM 0412.06

(2RS)-N-Methyl-2-(10H-phenothiazin-10-yl)propan1-amine Hydrochloride (Norisopromethazine Hydrochloride)

N S

H N x HCl

(A)

100 mg

Propafenone Hydrochloride
MM 0405.00 Propafenone Hydrochloride
O O N OH H

(A)
x HCl

500 mg

MM 0405.02

Imp. A (EP): 1-(2-Hydroxyphenyl)-3-phenylpropan1-one Imp. B (EP) as Hydrochloride: (2E)-1-[2-[(2RS)2-Hydroxy-3-(propylamino)propoxy]phenyl]3-phenylprop-2-en-1-one Hydrochloride


O O OH N H

OH

(A)

100 mg

MM 0405.03

(A)
x HCl

50 mg

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Pharmaceutical impurities
Code Product Price
O O O

Unit

MM 0405.04

Imp. C (EP): 1-[2-[[(2RS)-Oxiranyl]methoxy] phenyl]-3-phenylpropan-1-one Imp. D (EP): 1-[2-[(2RS)-2,3-Dihydroxy-propoxy] phenyl]-3-phenylpropan-1-one Imp. E (EP): 1-[2-[(2RS)-3-Chloro-2-hydroxypropoxy]phenyl]-3-phenylpropan-1-one Imp. F (EP): 1,1'-[2-Hydroxypropane1,3-diylbis(oxy-2,1-phenylene)]bis(3phenylpropan-1-one) Imp. H (EP): (2RS)-2-Phenyl-2,3-dihydro-4H-1benzopyran-4-one
O O OH O O

(A)

50 mg

MM 0405.05

O OH

OH

(A)

50 mg

MM 0405.06

O OH

Cl

(A)

50 mg

MM 0405.07

(A)

50 mg

MM 0405.09

(A)
O O

100 mg

MM 0405.01

5-Hydroxypropafenone Hydrochloride

O OH

N H x HCl

(A)

100 mg

OH

Propentofylline
MM 0875.01 3-Methyl-7-propylxanthine
HN O N O N N

(A)

100 mg

MM 0875.02

1-(3-Hydroxypropyl)-3-methyl-7-propylxanthine
HO O N

O N N N

(A)

100 mg

MM 0875.03

1,7-Bis-(5-oxohexyl)-3-methylxanthine
O N O N O N N

(A)

100 mg

Propofol
MM 0461.00 Propofol
OH

(A)

250 mg

MM 0461.03

Imp. A (EP): 2,4-Bis(1-methylethyl)phenol

OH

(A)

100 mg

MM 0461.04

Imp. C (EP): 2-(1-Methylethyl)phenol

OH

(C)

100 mg

MM 0461.02

Imp. E (EP): 3,3',5,5'-Tetrakis(1Methylethyl)bisphenyl-4,4'-diol

(A)
HO OH

100 mg

MM 0461.05 MM 0461.08

Imp. F (EP): 3-(1-Methylethyl)phenol Imp. G (EP): 2-(1-Methylethoxy)-1,3-bis (1-methylethyl)benzene

HO

(C) (A)
O

100 mg 100 mg

MM 0461.06

Imp. H (EP): 4-(1-Methylethyl)phenol

HO

(C)

100 mg

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197

Pharmaceutical impurities
Code Product Price
O

Unit

MM 0461.07 MM 0461.13

Imp. I (EP): Oxydibenzene Imp. J (EP): 2,6-Bis(1-methylethyl)benzene-1,4-dione

(B) (A)

100 mg 50 mg

MM 0461.11

Imp. K (EP): 1-(1-Methylethoxy)-2-(1-methylethyl)benzene


O

(A)

100 mg

MM 0461.15

Imp. M (Pharmeuropa): 2,6-Diisopropylbenzoic Acid

OH

(A)

50 mg

Propranolol Hydrochloride
MM 0043.00 Propranolol Hydrochloride
O OH H N

(A)
x HCl

500 mg

MM 0043.01

Imp. A (EP): (2RS)-3-(Naphthalen-1yloxy)propane-1,2-diol (Diol Derivative) Imp. B (EP) as Hydrochloride: 1,1'-[(1Methylethyl)imino]bis[3-(naphthalen-1yloxy)propan-2-ol] Hydrochloride (Tertiary Amine Derivative Hydrochloride) Imp. C (EP): 1,3-Bis(naphthalen-1-yloxy)propan-2-ol (Bis-ether Derivative) 1-Naphthol
OH O N x HCl OH

OH O OH

(A)

100 mg

MM 0043.03

(A)
O

100 mg

MM 0043.02

OH O O

(A)

50 mg

MM 0043.04

(B)
OH

100 mg

MM 0043.05

1-(1-Naphtyloxy)-2,3-epoxypropane

(A)

100 mg

Propyl Gallate
MM 1037.00 Propyl Gallate
O HO HO OH O

(A)

500 mg

Propyl Parahydroxybenzoate
MM 0432.00 Propyl Parahydroxybenzoate
HO O O

(A)

500 mg

MM 0045.01

Imp. A (EP): 4-Hydroxybenzoic Acid


HO

O OH

(B)

100 mg

MM 0431.00

Imp. B (EP): Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0498.00

Imp. C (EP): Ethyl 4-Hydroxybenzoate (Ethyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0496.00

Imp. D (EP): Butyl 4-Hydroxybenzoate (Butyl Parahydroxybenzoate)


HO

O O

(A)

500 mg

MM 0432.01

Sodium Propyl Parahydroxybenzoate


NaO

O O

(B)

100 mg

Propylhexidrine Hydrochloride
MM 0664.00 Propylhexidrine Hydrochloride
NH x HCl

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Propyphenazone
MM 0036.00 Propyphenazone
N N O

(A)

500 mg

MM 0036.05

Imp. A (EP): Phenazone


N N

(A)

100 mg

MM 0036.04

Imp. C (EP): 4-[(1RS)-1,3-Dimethylbutyl]1,5-dimethyl-2-phenyl-1,2-dihydro-3Hpyrazol-3-one

O N N

(A)

50 mg

Protionamide
MM 0844.01 Protionamide Sulphoxide
N O S NH2

(A)

50 mg

Proxymetacaine Hydrochloride
MM 0404.00 Proxymetacaine Hydrochloride
H2N O O O N x HCl

(A)

500 mg

MM 0404.01

3-Amino-4-propoxybenzoic Acid Hydrochloride

O H2N O OH x HCl

(A)

100 mg

MM 0404.02

Proxymetacaine N-Oxide Dihydrochloride


H2N O

O O N O x 2 HCl

(C)

50 mg

Proxyphylline
MM 1284.00 Proxyphylline
N O N OH O N N

(A)

250 mg

Pseudoephedrine Hydrochloride
MM 2115.01 Methcathinone Hydrochloride (2-Methylamino-1-phenylpropan-1-one Hydrochloride) [Controlled Substance] (1S,2S)-N-Acetylpseudoephedrine
O NH x HCl

(A)

100 mg

MM 2115.04

OH N O

(A)

100 mg

MM 2115.05

(1S,2S)-N,O-Diacetylpseudoephedrine

O O N O

(A)

100 mg

MM 0652.00

Imp. A (EP) as Hydrochloride: Ephedrine Hydrochloride [Drug Precursor] Imp. A (EP) as Sulphate: Ephedrine Sulphate [Drug Precursor] (1S,2S)-O-Acetylpseudoephedrine Hydrochloride
OH

OH

H N

(A)
x HCl

500 mg

MM 1147.00

H N 2

(A)
x H2SO4

250 mg

MM 2115.03

O O NH x HCl

(A)

50 mg

New MM 2115.10

(+)-Norpseudoephedrine Hydrochloride (Cathine Hydrochloride) [Controlled Substance]

OH NH2 x HCl

(A)

100 mg

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199

Pharmaceutical impurities
Code Product Price
OH NH

Unit

New MM 2115.11

(-)-Pseudoephedrine ((1R,2R)-Pseudoephedrine)

(A)

100 mg

Pyrazinamide
MM 0385.00 Pyrazinamide
O N N NH2

on request

MM 0385.01

Imp. A (EP): Pyrazine-2-carboxylic Acid

O N N OH

(A)

100 mg

Pyridostigmine Bromide
MM 0429.00 Pyridostigmine Bromide
N O O N+ Br-

(A)

100 mg

MM 0429.02

Imp. B (EP) as Iodide: 3-Hydroxy-1-methylpyridinium Iodide

HO

N+

I-

(A)

100 mg

Pyridoxine Hydrochloride
MM 0021.00 Pyridoxine Hydrochloride
HO OH N OH x HCl

(A)

500 mg

MM 0021.01

Imp. A (EP) as Hydrochloride: 6-Methyl1,3-dihydrofuro[3,4-c]pyridin-7-ol Hydrochloride Imp. B (EP) as Hydrochloride: 5-(Hydroxymethyl)2,4-dimethylpyridin-3-ol Hydrochloride Pyridoxine Diacetate

N HO O x HCl

(D)

100 mg

MM 0021.02

N HO
N HO O O O O

(A)
OH x HCl

100 mg

MM 0021.03

(A)

100 mg

MM 0021.05

Pyridoxal Hydrochloride
HO

N OH O x HCl

(A)

100 mg

MM 0021.06

Pyridoxamine Dihydrochloride
HO

N OH NH2 x 2 HCl

(A)

100 mg

MM 0021.07

4-Pyridoxic Acid
HO O

N OH OH

(D)

50 mg

Quetiapine Fumarate
New MM 1130.00 Quetiapine Fumarate
N S 2 HO N x O N O OH OH O

100 mg

New MM 1130.15

Imp. A (Pharmeuropa) as Maleate: 2-[2-[4(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin1-yl]ethoxy]ethyl Acetate Maleate


S

O N N N x O O O OH OH O

(A)

50 mg

MM 1130.01

Imp. B (Pharmeuropa) as Dihydrochloride: 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine Dihydrochloride


S

NH N N x 2 HCl

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
N NH2 S x O O N O O OH OH OH

Unit

New MM 1130.16

Imp. F (Pharmeuropa) as Maleate: [2-[(2-Aminophenyl)thio]phenyl][4-[2-(2-hydroxyethoxy)ethyl]piperazin-1-yl]methanone Maleate

(A)

50 mg

MM 1130.09

Imp. G (Pharmeuropa): Dibenzo[b,f][1,4]thiazepin11(10H)-one


S

H N

(A)

100 mg

MM 1130.10

Imp. H (Pharmeuropa): 2-[2-[4-(Dibenzo[b,f][1,4]thiazepin-11-yl)-1-oxidopiperazin-1-yl]ethoxy]ethanol (Quetiapine N-Oxide)


S

O N N N

OH

(A)

50 mg

New MM 1130.14

Imp. I (Pharmeuropa) as Fumarate: 2-[4-(Dibenzo[b,f][1,4]thiazepin11-yl)piperazin-1-yl]-ethanol Fumarate


S

N N N

OH O x

OH

(A)

50 mg

O HO
O

New MM 1130.17

Imp. K (Pharmeuropa) as Fumarate: N-(2[[2-([4-[2-(2-Hydroxyethoxy)ethyl]piperazin1-yl]carbonyl)phenyl]thio]phenyl)acetamide Fumarate


O

N O S NH N

OH O x

OH

(A)

50 mg

O HO

Quinapril Hydrochloride
MM 0011.01 4-Amino-6-chlorobenzene-1,3-disulphonamide (Salamide) Imp. B (Pharmeuropa): (2S)-2-[[(1S)-1(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoic Acid
O H2 N S O O S O NH2

(B)

100 mg

Cl

NH2

MM 0010.05

H N O O

O OH

(A)

100 mg

Quinine Dihydrochloride
MM 0458.00 Quinine Dihydrochloride
HO O N H N x 2 HCl H

(A)

500 mg

Quinuclidinyl Benzilate
MM 0783.09 Benzilic Acid
HO O OH

(B)

100 mg

MM 0825.02

3-Quinuclidinol

N OH

(A)

100 mg

Rabeprazole Sodium
MM 0618.01 Rabeprazole Sodium
O Na N S N O N O

on request

MM 0618.00

Rabeprazole
O H N S N O N

on request

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201

Pharmaceutical impurities
Code Product Price
O H N S N N O

Unit

MM 0618.02

2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl] methyl]thio]-1H-benzimidazole

(A)

100 mg

MM 0618.03

Rabeprazole Sulphone
H N N N O S O O

(A)

100 mg

MM 0618.04

Rabeprazole N-Oxide
H N S N N O O O

(D)

100 mg

MM 0618.05

Rabeprazole Sulphone N-Oxide


H N N N O O S O O

(A)

100 mg

MM 0618.07

2-Chloromethyl-3-methyl-4-(3-methoxypropoxy) pyridine Hydrochloride


Cl N

O O x HCl

(A)

100 mg

Racecadotril
New MM 1337.00 Racecadotril
O N H S O O O

(A)

100 mg

Raloxifene Hydrochloride
MM 0738.00 Raloxifene Hydrochloride
HO S OH x HCl O O N

(A)

100 mg

MM 0738.01

Imp. C (EP): [6-Hydroxy-2-(4-hydroxyphenyl)-1benzothiophen-3-yl][4-[2-(piperidin-1-yl)ethoxy]phenyl]methanone N-Oxide (Raloxifene N-Oxide)

O O HO

O N

(A)

50 mg

S OH

Ramipril
MM 0448.05 Imp. D (EP): Ethyl (2S)-2-[(3S,5aS,8aS,9aS)-3Methyl-1,4-dioxodecahydro-2H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-2-yl]-4-phenylbutanoate (Ramipril Diketopiperazine)
O H H O N O N H O

(A)

100 mg

MM 0010.05

Imp. F (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)3-phenylpropyl]amino]propanoic Acid


O

H N O

O OH

(A)

100 mg

MM 0291.04 MM 0448.04

Imp. G (EP): Methylbenzene (Toluene) Imp. M (EP): (2R,3R)-2,3-Bis(benzoyloxy)butanedioic Acid (Dibenzoyltartric Acid)
O O O HO O OH O O

(C) (A)

100 mg 100 mg

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Pharmaceutical impurities
Code Product Price Unit

MM 0448.11

(2S,3aS,6aS)-Octahydro-cyclopenta[b]pyrrole2-carboxylic Acid Phenylmethyl Ester Hydrochloride


H

(A)
O HN H O x HCl

100 mg

Ranitidine Hydrochloride
MM 0086.00 Ranitidine Hydrochloride
N O S H N H N x HCl NO2

(A)

500 mg

MM 0086.02

Imp. A (EP): N,N'Bis[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-2-nitroethene1,1-diamine Imp. B (EP): 2-[[[5-[(Dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethanamine Imp. C (EP): N-[2-[[[5-[(Dimethylamino)methyl]furan-2-yl]methyl]sulphinyl]ethyl]-N'methyl-2-nitroethene-1,1-diamine (Ranitidine Sulphoxide) Imp. D (EP) as Sodium Salt: N-[2-[[[5[(Dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-2-nitroacetamide Sodium Salt Imp. E (EP): N-[2-[[[5-[(Dimethyloxidoamino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]N'-methyl-2-nitroethene-1,1-diamine (Ranitidine N-Oxide) Imp. F (EP) as Hydrochloride: [5-[(Dimethylamino)methyl]furan-2-yl]methanol Hydrochloride Imp. G (EP): 3-(Methylamino)-5,6-dihydro-2H-1,4thiazin-2-one Oxime Imp. H (EP): N-Methyl-2-nitroacetamide

H N

H N NO2

(A)

100 mg

MM 0086.01 MM 0086.03

NH2

(A) (A)

100 mg 100 mg

S O

H N

H N

NO2
O H N

MM 0086.06

ONa

(A)

100 mg

NO2 O N H N H N

MM 0086.05

(D)

100 mg

NO2
O

MM 0086.17 MM 0086.07 MM 0086.08

OH

x HCl

(A) (A) (A)

100 mg 100 mg 100 mg

S N

N N H

OH

NO2 O N H
H N NO2 N S NO2 N H N H
NO2

MM 0086.10

Imp. I (EP): 2,2'-Methylenebis[N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-N'methyl-2-nitroethene-1,1-diamine]

H N

(A)

100 mg

MM 0220.09

Imp. K (EP): N-Methyl-1-methylthio-2nitroethenamine ((EZ)-N-Methyl-1-(methylsulphanyl)-2-nitroethen-1-amine)

(A)

100 mg

N H

Ranolazine Dihydrochloride
MM 1320.01 2-[(2-Methoxyphenoxy)methyl]oxirane
O O O

(A)

100 mg

Reagents
MM 0334.01 Diethylhexylphthalate (Bis-(2-ethylhexyl) Phthalate)
O O O O

(C)

500 mg

MM 0334.02 MM 0334.03

3-(N-Morpholino)propane Sulfonic Acid (MOPS)


O

OH S O O

(C) (C)

500 mg 500 mg

3-(N-Morpholino)ethane Sulfonic Acid (MES)


N O

O O S OH

MM 0334.08

Salicylaldehyde Azine
N N OH

HO

(A)

100 mg

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203

Pharmaceutical impurities
Code Product Price Unit

Repaglinide
MM 0944.00 Repaglinide
N N H O O O OH

(A)

100 mg

MM 0944.02

Imp. B (EP): [3-Ethoxy-4-(ethoxycarbonyl)phenyl]acetic Acid


HO

O O O
O N NH2 x HO HN O O OH

(A)
O

100 mg

MM 0944.01

Imp. C (EP) as N-Acetyl-L-glutamate: (1S)3-Methyl-1-[2-(piperidin-1-yl)phenyl]butan1-amine N-Acetyl-L-glutamate

(A)

100 mg

Ribavirin
MM 0542.00 Ribavirin
H2N HO N O OH OH N O N

(A)

250 mg

MM 0542.01

Imp. A (EP): 1--D-Ribofuranosyl-1H-1,2,4triazole-3-carboxylic Acid

O HO HO N O OH OH N N

(D)

100 mg

MM 0542.03

Imp. C (EP): 1H-1,2,4-Triazole-3-carboxylic Acid


HO

O N N N H

(D)

100 mg

MM 0542.04

Imp. D (EP): 1H-1,2,4-Triazole-3-carboxamide


H2N

O N N N H

(D)

100 mg

MM 0542.05

1-(5-O-Benzoyl--D-ribofuranosyl)-1H-1,2,4triazole-3-carboxamide (5'-O-Benzoylribavirin)
O

O H2N O N O OH OH N N

(D)

100 mg

MM 0542.06

Imp. F (EP): 1-(5-O-Acetyl--D-ribofuranosyl)-1H1,2,4-triazole-3-carboxamide (5'-O-Acetylribavirin)


O

O H2 N O N O OH OH N N

(D)

100 mg

Riboflavin
MM 0030.00 Riboflavin
OH HO OH N OH

(A)

500 mg

N N

NH O

Risedronate Sodium 2.5 Hydrate


MM 0777.00 Risedronate Sodium 2.5 Hydrate
N OH O OH HO P x 2,5 H2O OH P ONa O OH O OH HO P OH P OH O OH O OH HO P OH P OH O

(A)

100 mg

New MM 0777.02

Imp. B (Pharmeuropa): [1-Hydroxy-2-(pyridin2-yl)ethane-1,1-diyl]bis(phosphonic Acid)


N

(A)

50 mg

New MM 0777.03

Imp. C (Pharmeuropa): [1-Hydroxy-2-(pyridin4-yl)ethane-1,1-diyl]bis(phosphonic Acid)

(A)

50 mg

204

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Pharmaceutical impurities
Code Product Price Unit

Risperidone
MM 0491.00 Risperidone
N O N O N N F

(A)

100 mg

MM 0491.01

Imp. A (EP): 3-[2-[4-[(E)-(2,4-Difluorophenyl)(hydroxyimino)methyl]piperidin-1-yl]ethyl]-2methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one Imp. B (EP): 3-[2-[4-[(Z)-(2,4-Difluorophenyl)(hydroxyimino)methyl]piperidin-1-yl]ethyl]-2methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one Imp. C (EP): (9RS)-3-[2-[4-(6-Fluoro1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9hydroxy-2-methyl-6,7,8,9-tetrahydro-4Hpyrido[1,2-a]pyrimidin-4-one (9-Hydroxyrisperidone) Imp. D (EP): 3-[2-[4-(5-Fluoro-1,2-benzisoxazol3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one Imp. E (EP): (6RS)-3-[2-[4-(6-Fluoro-1,2benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6dimethyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one Imp. F (EP): 2-[2-Methyl-4-oxo-6,7,8,9-tetrahydro4H-pyrido[1,2-a]pyrimidin-3-yl]ethyl 4-(6-Fluoro1,2-benzisoxazol-3-yl)piperidin-1-carboxylate Imp. H (EP): 3-[2-[4-(2,4-Difluorobenzoyl)piperidin1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one 3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4Hpyrido-[1,2-a]pyrimidin-4-one Imp. L (EP) as Hydrochloride: 3-(2-Chloroethyl)2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one Hydrochloride (Risperidone Piperidopyrimidinone Intermediate Hydrochloride) 3-[2-[4-[2-Fluoro-4-[4-(6-fluoro1,2-benzisoxazol-3-yl)piperidin1-yl]benzoyl]piperidin-1-yl]ethyl]-2-methyl6,7,8,9-tetrahydro-4H-pyrido-[1,2-a]pyrimidin-4-one
N N O

N N O HO N F N F

(D)

100 mg

MM 0491.02

N N O N F OH N F

(A)

100 mg

MM 0491.03

OH N N O N O N F

(D)

100 mg

MM 0491.04

N N O N

(D)

100 mg

N O

MM 0491.05

N N O N O F N

(D)

50 mg

MM 0491.08

O F O N

(A)

100 mg

N O

MM 0491.10

N N O O F N F

(A)

100 mg

MM 0491.09

N N O O OH N F

(A)

100 mg

MM 0491.13

N N O
F

(A)
Cl x HCl

100 mg

MM 0491.18

(D)

50 mg

N N O O F N N

O N

Ritodrine Hydrochloride
MM 0063.06 Imp. A (BP): Tyramine
HO NH2

(B)

100 mg

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205

Pharmaceutical impurities
Code Product Price Unit

Ritonavir
MM 1034.00 Ritonavir
S N N O N H H N O OH O N H O S N

(A)

100 mg

Ronidazole
MM 1026.01 (1-Methyl-5-nitroimidazol-2-yl)methanol
O2 N N N

(A)
OH

100 mg

Rosiglitazone Maleate
MM 0522.01 Rosiglitazone Maleate
N N O S NH O O O x O OH OH

(D)

100 mg

New MM 0522.04

Imp. A (Pharmeuropa): 3-[4-[2-[Methyl(pyridin2-yl)amino]ethoxy]phenyl]propanamide

N N O NH2 O

(A)

50 mg

Rosuvastatin Calcium
MM 0936.01 4-(4-Fluorophenyl)-6-isopropyl2-[methyl(methylsulfonyl)amino]pyrimidine5-carbaldehyde
N N O O S N

(A)

100 mg

MM 0936.02

4-(4-Fluorophenyl)-6-isopropyl2-[methyl(methylsulfonyl)amino]pyrimidine5-methanol

O O S N N N

(A)

100 mg

HO

F
O O S N

New MM 0936.03

5-Oxorosuvastatin Methyl Ester


N

(A)

100 mg

O O

OH O

Rotigotine
New MM 1403.02 Despropylrotigotine ((6S)-5,6,7,8-Tetrahydro6-[[2-(2-thienyl)ethyl]amino]-1-naphthalenol)
OH

(A)
N H S
OH x OH O

50 mg

New MM 1403.03

(S)-2-Amino-5-methoxytetralin (S)-Mandelate

(A)

50 mg

NH2

New MM 1403.04

Despropylrotigotine Methyl Ether Hydrochloride

O x HCl N H S

(A)

100 mg

Roxatidine Acetate Hydrochloride


MM 0597.03 N-[3-[3-[(Piperidin-1-yl)methyl]phenoxy]propan1-yl]phthalimide Hydrochloride
O N O O N x HCl

(A)

50 mg

206

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Pharmaceutical impurities
Code Product Price Unit

Rutoside Trihydrate
MM 0109.03 Imp. C (EP) as Dihydrate: 2-(3,4-Dihydroxyphenyl)3,5,7-trihydroxy-4H-1-benzopyran-4-one Dihydrate (Quercetin Dihydrate)
HO O HO O x 2 H2O OH

(A)

100 mg

OH OH

Saccharin Sodium
MM 0818.00 Saccharin Sodium
O O S NNa O

(A)

500 mg

Salbutamol Sulphate
MM 0381.00 Salbutamol Sulphate
HO OH 2
OH H N

OH

H N x H2SO4

(A)

500 mg

MM 0381.02

Imp. B (EP): (1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol


HO

(A)

50 mg

MM 0381.03

Imp. C (EP): (1RS)-2-[(1,1-Dimethylethyl)amino]1-(4-hydroxy-3-methylphenyl)ethanol


HO

OH

H N

(A)

50 mg

MM 0381.05

Imp. E (EP): (1RS)-2-[Benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanol


HO

(A)
OH N

100 mg

OH

MM 0381.07

Imp. G (EP) as Hydrochloride: 2-[Benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy3-(hydroxymethyl)phenyl]ethanone Hydrochloride


HO

(D)
O N x HCl

50 mg

OH

MM 0381.08

4-[2-[(1,1-Dimethylethyl)amino]ethyl]-2-methylphenol
HO

H N

(A)

100 mg

New MM 0381.09

Imp. I (EP): (1RS)-2-[(1,1-Dimethylethyl)amino]-1[4-(benzyloxy)-3-(hydroxymethyl)phenyl]ethanol


O

OH

H N

(A)

50 mg

OH

MM 0381.10

Imp. J (EP) as Hydrochloride: 2-[(1,1-Dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone Hydrochloride (Salbutamone Hydrochloride) 4-[(1RS)-2-(tert-Butylamino)-1-hydroxyethyl]-2ethylphenol Hydrobromide

H N x HCl

(D)

50 mg

HO OH

MM 0381.17

OH

H N x HBr

(A)

50 mg

HO

Salicylic Acid
MM 0045.00 Salicylic Acid
O OH OH

(A)

500 mg

MM 0045.01

Imp. A (EP): 4-Hydroxybenzoic Acid


HO

(B)
OH

100 mg

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207

Pharmaceutical impurities
Code Product Price
O HO O OH OH

Unit

MM 0045.02

Imp. B (EP): 4-Hydroxyisophthalic Acid

(A)

100 mg

MM 0045.11 MM 0045.12

Imp. C (EP): Phenol


OH

(B)
O O OH

100 mg 100 mg

Imidazole Salicylate

H N N H

(A)

MM 0045.13

Choline Salicylate

O O OH N OH

on request

MM 0045.14

N,N-Diethylsalicylamide

O N OH

(A)

100 mg

Salmeterol Xinafoate
MM 0536.03 Imp. B (EP): (1RS)-1-[4-Hydroxy-3-(hydroxymethyl)phenyl]-2-[[6-(2-phenylethoxy)hexyl]amino]ethanol Imp. F (EP): (1RS)-1-(4-Hydroxy-3-methylphenyl)2-[[6-(4-phenylbutoxy)hexyl]amino]ethanol
HO

OH

H N O

(A)

100 mg

HO OH

MM 0536.07

OH

H N O

(A)

50 mg

Secnidazole
MM 0119.00 Secnidazole
O2N N N OH

(A)

100 mg

MM 0012.02

2-Methyl-4-nitroimidazole

O2N

NH N

(B)

100 mg

Secobarabital
New MM 1361.00 Secobarbital [Controlled Substance]
O H N O NH O

(A)

100 mg

Selegiline Hydrochloride
New MM 0216.00 Selegiline Hydrochloride
N x HCl

(A)

100 mg

MM 0656.00

Imp. C (EP) as Hydrochloride: (1RS, 2SR)-2Amino-1-phenylpropan-1-ol Hydrochloride (Phenylpropanolamine Hydrochloride) Imp. D (EP) as Racemate Hydrochloride: N-[(1RS)-1-Methyl-2-phenylethyl]prop-2-yn-1amine Hydrochloride (rac-Demethylselegiline Hydrochloride)

OH NH2 x HCl

(A)

500 mg

and enatiomer

New MM 0216.09

H N

x HCl

(A)

100 mg

Sertraline Hydrochloride
MM 0317.01 Sertraline Hydrochloride
HN

(A)
x HCl Cl

100 mg

Cl

MM 0317.00

Sertraline

HN

(A)

100 mg

Cl Cl

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Pharmaceutical impurities
Code Product Price
HN

Unit

MM 0317.05

Imp. B (EP) as Hydrochloride: (1RS,4RS)-NMethyl-4-phenyl-1,2,3,4-tetrahydronaphthalen1-amine Hydrochloride

(A)
x HCl

100 mg

and enantiomer

MM 0317.06

Imp. C (EP) as Hydrochloride: (1RS,4RS)-44-Chlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine Hydrochloride

HN

(D)

100 mg

x HCl

Cl and enantiomer

MM 0317.10

Imp. E (EP): (2R)-Hydroxyphenylacetic Acid ((R)-Mandelic Acid) Imp. E (EP) as Racemate: Hydroxyphenylacetic Acid (Mandelic Acid) Imp. F (EP) as Racemate: 4-(3,4-Dichlorophenyl)3,4-dihydronaphthalen-1(2H)-one (Sertraline Tetralone Derivative)
O

O OH OH

(A)

100 mg

MM 0792.03

O OH OH

(A)

100 mg

MM 0317.09

(A)

100 mg

Cl Cl

Sibutramine Hydrochloride
MM 0991.04 Imp. A (Pharmeuropa) as Hydrochloride: (1RS)1-[1-(2-Chlorophenyl)cyclobutyl]-N,N,3-trimethylbutan-1-amine Hydrochloride Imp. B (Pharmeuropa) as Hydrochloride: (1RS)1-[1-(3-Chlorophenyl)cyclobutyl]-N,N,3-trimethylbutan-1-amine Hydrochloride Imp. C (Pharmeuropa) as Hydrochloride: (1RS)1-[1-(4-Chlorophenyl)cyclobutyl]-N,N-dimethylpentan-1-amine Hydrochloride Imp. D (Pharmeuropa) as Hydrochloride: (1RS)1-[1-(4-Chlorophenyl)cyclobutyl]N,3-dimethylbutan-1-amine Hydrochloride (N-Monodesmethylsibutramine Hydrochloride) Imp. E (Pharmeuropa): (4-Chlorophenyl)acetonitrile
Cl
Cl N

Cl x HCl N

(A)

50 mg

MM 0991.05

(A)
x HCl

50 mg

MM 0991.06

(A)
x HCl Cl N

50 mg

MM 0991.02

Cl

HN x HCl

(A)

100 mg

MM 0991.07 MM 0991.03

N Cl

(A) (A)

50 mg 100 mg

Imp. G (Pharmeuropa) as Hydrochloride: (1RS)1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan1-amine Hydrochloride (N,N-Didesmethylsibutramine Hydrochloride) Imp. H (Pharmeuropa): 2-(4-Chlorophenyl)-2-(prop2-en-1-yl)pent-4-enenitrile

NH2 x HCl

MM 0991.09

(A)
N Cl

50 mg

MM 0991.10

Imp. I (Pharmeuropa): (1RS)-1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-ol


Cl OH

(A)

50 mg

MM 0991.11

Imp. J (Pharmeuropa): 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan-1-one


Cl O

(A)

50 mg

Sibutramine Hydrochloride Monohydrate


MM 0991.00 Sibutramine Hydrochloride Monohydrate
Cl N x HCl x H2O

(A)

100 mg

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209

Pharmaceutical impurities
Code Product Price Unit

Sildenafil Citrate
MM 0254.00 Sildenafil Citrate
O N N S O
O O N N S O O O N N S O
O N N S O
O O N N O S O O HN N N N

O O HN N N N x HO

O O OH O

(D)

100 mg

HO HO

MM 0254.09

Sildenafil
O HN

(D)
N N

100 mg

MM 0254.01

4-[[2-Ethoxy-5-[(4-methyl-1-piperazinyl)sulfonyl]benzoyl]amino]-1-methyl-3-propyl-1Hpyrazole-5-carboxamide 2-Ethoxy-5-[(4-methyl-1-piperazinyl)sulfonyl] benzoic Acid Imp. B (Pharmeuropa): 5-[2-Ethoxy-5-[(4methyl-4-oxidopiperazin-1-yl)sulfonyl]phenyl]1-methyl-3-propyl-6,7-dihydro-1Hpyrazolo[4,3-d]pyrimidin-7-one (Desethylsildenafil) 4-Amino-1-methyl-3-propyl-1H-pyrazole5-carboxamide

on request
N N

H2N N H

MM 0254.02

O OH

(A)

100 mg

MM 0254.04

(A)

100 mg

MM 0254.05

O H 2N H2N N N

(A)

100 mg

MM 0254.06

Imp. D (Pharmeuropa): 4-Ethoxy-3-(1-methyl7-oxo-3-propyl-6,7-dihydro-1Hpyrazolo[4,3-d]pyrimidin-5-yl)benzenesulfonic Acid (3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1Hpyrazolo[4,3-d]pyrimidin-5yl]-4-ethoxybenzenesulfonic Acid) 1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1Hpyrazolo[4,3-d]pyrimidin-5-yl)4-ethoxyphenyl]sulfonyl]piperazine (Desmethylsildenafil) 3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1Hpyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxy-N[2-(methylamino)ethyl]benzenesulfonamide 2-Ethoxy-5-(4-methylpiperazine-1-sulfonyl)benzaldehyde (1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine)

O O HO S O O HN N N N

(D)

100 mg

MM 0254.08

O O N HN S O O HN N N N

(D)

100 mg

MM 0254.11

O O N H S O
O N N S O O O

(D)
N N

100 mg

HN N

NH

MM 0254.21

(A)

100 mg

MM 0254.22

Imp. C (Pharmeuropa): 5-[2-Hydroxy-5-[(4methylpiperazin-1-yl)sulfonyl]phenyl]-1methyl-3-propyl-6,7-dihydro-1H-pyrazolo[4,3-d]pyrimidin-7-one (Desethylsildenafil) 5-(2-Ethoxyphenyl)-1-methyl-3n-propyl1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one

O O N N S O HN N OH
O HN N O N N

(D)
N N

100 mg

MM 0254.29

(A)

100 mg

Silybin
MM 0472.00 Silybin
HO O OH OH O O O OH O OH

(A)

100 mg

210

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Pharmaceutical impurities
Code Product Price Unit

Simvastatin
MM 0158.00 Simvastatin
O H OH O O O

(A)

100 mg

MM 0158.01

Imp. A (EP) as Sodium Salt: (3R,5R)-7[(1S,2S,6R,8S,8aR)-8-[(2,2-Dimethylbutanoyl)oxy]2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt (Tenivastatin Sodium Salt; Simvastatin Hydroxy Acid Sodium Salt)

O OH H ONa OH O O

(A)

100 mg

MM 0158.02

Imp. B (EP): (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(Acetyloxy)6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8ahexahydronaphthalen-1-yl 2,2-Dimethylbutanoate (Simvastatin Acetate Ester)

O O H O O O O

(A)

100 mg

MM 0158.03

Imp. C (EP): (1S,3R,7S,8S,8aR)-3,7-Dimethyl-8-[2-[(2R)-6-oxo3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen1-yl 2,2-Dimethylbutanoate (Anhydrosimvastatin)

O O H O O

(A)

100 mg

MM 0050.00

Imp. E (EP): Lovastatin


O H O

(A)
OH

100 mg

Sodium Benzoate
MM 0730.00 Sodium Benzoate
O ONa

(A)

500 mg

Sodium Cromoglicate
MM 0039.00 Sodium Cromoglicate
NaO O O OH O O O O O O ONa

(A)

500 mg

MM 0039.01

Succinophenone; Diphenacyl

(A)
O

100 mg

MM 0039.02

1,3-Bis(2-acetyl-3-hydroxyphenoxy)-2-propanol

HO OH O O O

OH

(A)

100 mg

MM 0039.03

Imp. A (EP): 1-(2,6-Dihydroxyphenyl)ethanone (2',6'-Dihydroxyacetophenone)


OH

OH

(B)

100 mg

MM 0039.04

Imp. B (EP): Diethyl 5,5'-[(2-hydroxypropane1,3-diyl)dioxy]bis(4-oxo-4H-1-benzopyran-2carboxylate (Ethyl Cromoglicate)

O O O OH O O O O O

O O

(A)

100 mg

Sodium Cyclamate
MM 0678.05 MM 0093.17 MM 0678.03 Cyclamic Acid Imp. B (EP) as Hydrochloride: Aniline Hydrochloride (Phenylamine Hydrochloride) Imp. C (EP): Cyclohexanamine
H N O
NH2 x HCl

OH O

(A) (B) (C)

100 mg 100 mg 100 mg

NH2

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211

Pharmaceutical impurities
Code Product Price
H N

Unit

MM 0678.04

Imp. D (EP): N-Cyclohexylcyclohexanamine

(C)

100 mg

Sodium Fluoride
MM 0734.00 Sodium Fluoride
NaF

(A)

500 mg

Sodium Picosulfate
MM 0054.00 Sodium Picosulfate
NaO O S O O O O S ONa O

(A)

500 mg

MM 0054.01

Imp. A (EP): 4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenyl Sodium Sulphate (4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]phenyl Sodium Sulphate) Imp. B (EP): 4,4'-[(Pyridin-2-yl)methylene]diphenol (4,4'-(Pyridin-2-ylmethylene)diphenol) Imp. C (EP): 2-[(RS)-(Pyridin-2-yl)[4-(sulphonatooxy)phenyl]methyl]phenyl Disodium Sulphate (2,4'-[(Pyridin-2-yl)-methylene]bisphenyl Bis(Sodium Sulphate)) 2,4'-[(Pyridin-2-yl)methylene]bisphenol (2-[(RS)(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenol)

HO

O O

ONa O

(A)

100 mg

MM 0031.01

HO

OH

(A)

100 mg

MM 0054.02

ONa S O O

(D)

50 mg

NaO

O S N O O
HO

MM 0031.04

(A)
N OH

50 mg

Sodium Salicylate
New MM 1370.00 Sodium Salicylate
O ONa OH

(A)

250 mg

Sodium Thiophene-2-carboxylate
MM 1081.00 Sodium Thiophene-2-carboxylate
O S ONa

(A)

250 mg

Sorbic Acid
MM 0954.00 Sorbic Acid
O OH

(A)

500 mg

Sotalol Hydrochloride
MM 0046.00 Sotalol Hydrochloride
O S O N H
H N O S O N H x HCl

OH

H N x HCl

(A)

100 mg

MM 0046.01

Imp. A (EP) as Hydrochloride: N-[4-[2[(1-Methylethyl)amino]ethyl]phenyl]methanesulphonamide Hydrochloride Imp. B (EP) as Hydrochloride: N-[4-[[(1Methylethyl)amino]acetyl]phenyl]methanesulphonamide Hydrochloride Imp. C (EP):N-(4-Formylphenyl) methanesulphonamide
O S O

(A)

100 mg

MM 0046.02

H N x HCl

(A)

100 mg

N H
O O S O N H

MM 0046.03

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Spironolactone
MM 0197.00 Spironolactone
O O

(A)

500 mg

O O

MM 0197.01

Imp. F (EP): (2'R)-3',4'-Dihydro-5'H-spiro[androst4,6-diene-17,2'-furan]-3,5'-dione (Canrenone)

O O

(A)

100 mg

Stanozolol
MM 1285.00 Stanozolol
N N H H OH

(A)

100 mg

Stavudine
MM 0534.00 Stavudine
HN HO O O N O

(A)

100 mg

MM 0534.01

Imp. A (EP): 5-Methylpyrimidine-2,4(1H,3H)-dione (Thymine)


O

O HN N H
O HN HO O O N

(A)

100 mg

MM 0534.03

Imp. C (EP): 1-(2-Deoxy--D-erythro-pentofuranosyl)5-methylpyrimidine-2,4(1H,3H)-dione (Thymidine)

(A)

100 mg

OH

Strychnine Nitrate
MM 0658.00 Strychnine Nitrate
N O H H H O N x HNO3

(A)

500 mg

MM 0658.02

Strychnine N-Oxide Hydrochloride


N O

H H

O N x HCl H O

(A)

100 mg

Sulfacetamide
MM 0579.00 Sulfacetamide
H2N O O O S N H

(A)

500 mg

Sulfacetamide Sodium
MM 1087.00 Sulfacetamide Sodium Monohydrate
H2N O O O S N Na

(A)
x H2O

500 mg

MM 0227.05

Imp. A (EP): Sulfanilamide


H2N

O O S NH2

(A)

100 mg

Sulfadiazine
MM 0623.00 Sulfadiazine
H2N O O N S N N H

(A)

500 mg

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213

Pharmaceutical impurities
Code Product Price
N H2N N
O O S OH H2N

Unit

MM 0623.03 MM 0227.04

Imp. A (EP): Pyrimidin-2-amine Imp. B (EP): 4-Aminobenzenesulfonic Acid (Sulphanilic Acid) Imp. D (EP): 4-Aminobenzenesulfonamide (Sulfanilamide)
H2N

(A) (A)

100 mg 100 mg

MM 0227.05

O O S NH2

(A)

100 mg

MM 0623.02

Imp. E (EP): N-[4-(Pyrimidin-2-ylsulfamoyl)phenyl]acetamide (Acetylsulfadiazine)

O N H

O O N S N N H

(A)

50 mg

MM 0623.07

N-[(4-Aminophenyl)sulfonyl]-N-(pyrimidin-2-yl)acetamide (Acetylsulfadiazine)
H2N

O O N S N N O

(A)

50 mg

Sulfadimidine
MM 0581.00 Imp. A (Pharmeuropa): 4-Amino-N-(4-methyl-2pyrimidyl)benzenesulphonamide (Sulfamerazine)
H2N

(A)
O O N S N N H

500 mg

MM 623.00

Imp. B (Pharmeuropa): 4-Amino-N-pyrimidin-2ylbenzenesulphonamide (Sulfadiazine)


H2N

O O N S N N H

(A)

500 mg

MM 0883.00

Imp. C (Pharmeuropa): (4-Aminophenylsulphonyl)guanidine (Sulfaguanidine)


H2N

O O NH S N NH2 H

(A)

100 mg

MM 0227.05

Imp. D (Pharmeuropa): 4-Aminobenzenesulphonamide (Sulfanilamide)


H2N

O O S NH2

(A)

100 mg

MM 0579.00

Imp. E (Pharmeuropa): N-[(4-Aminophenyl)sulfonyl]acetamide (Sulfacetamide)


H2N

O O O S N H

(A)

500 mg

MM 0227.04

Imp. F (Pharmeuropa): 4-Aminobenzenesulphonic Acid (Sulphanilic Acid)


H2N

O O S OH

(A)

100 mg

Sulfadimethoxine Sodium
MM 1020.00 Sulfadimethoxine Sodium
O O S N Na H2N N O N O

(A)

500 mg

Sulfafurazole
MM 0583.00 Sulfafurazole
H2N N O O O S N H

(A)

500 mg

Sulfaguanidine
MM 0883.00 Sulfaguanidine
H2N O O NH S N NH2 H

(A)

100 mg

MM 0227.05

Imp. A (EP): 4-Aminobenzenesulphonamide (Sulphanilamide)


H2N

O O S NH2

(A)

100 mg

MM 0883.02

Imp. B (EP): N-[(4-Aminophenyl)sulphonyl]urea (Sulphacarbamide)


H2N

O O O S N NH2 H

(A)

50 mg

214

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Pharmaceutical impurities
Code Product Price Unit

Sulfamerazine
MM 0581.00 Sulfamerazine
O O N S N N H H2N

(A)

500 mg

MM 0227.05

Sulphanilamide
H2N

O O S NH2

(A)

100 mg

Sulfamethoxazole
MM 0227.00 Sulfamethoxazole
O S H2N O N H N O

(A)

500 mg

MM 0227.01

Imp. A (EP): N-[4-[(5-Methylisoxazol-3-yl)sulphamoyl]phenyl]acetamide


O N H

(A)
O S O N H N O

100 mg

MM 0227.03

Imp. B (EP): 4-[[(4-Aminophenyl)sulphonyl]amino]N-(5-methylisoxazol-3-yl)benzenesulphonamide


O O S N H H2N

O O S N H

(A)
O N

100 mg

MM 0227.02

Imp. C (EP): 5-Methylisoxazol-3-amine


O H2N N
O S H2N OH

(B)

100 mg

MM 0227.04

Imp. D (EP): 4-Aminobenzenesulphonic Acid (Sulphanilic Acid) Imp. E (EP): 4-Aminobenzenesulphonamide (Sulphanilamide)
H2N

(A)

100 mg

MM 0227.05

O S

O NH2

(A)

100 mg

Sulfamethylphenazole
MM 1108.00 Sulfamethylphenazole
O O S N H H2N

(A)
N N

100 mg

Sulfaquinoxaline Sodium
MM 0702.00 Sulfaquinoxaline Sodium
N N NH 2 Na N O S O

on request

Sulfasalazine
MM 0045.00 Imp. H (EP): Salicylic Acid
HO O OH

(A)

500 mg

Sulfathiazole
MM 0578.00 Sulfathiazole
H2N O O S N H N S

(A)

500 mg

Sulfinpyrazone
New MM 1309.02 Imp. B (EP): 1,2-Diphenyl-4-[2-(phenylsulfanyl)ethyl]pyrazolidine-3,5-dione
O N N O S

(A)

50 mg

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215

Pharmaceutical impurities
Code Product Price Unit

Sulindac
MM 0624.00 Sulindac
S O F O OH

(A)

500 mg

Sulpiride
MM 0051.00 Sulpiride
O H2N O O S O N H N

(A)

500 mg

MM 0051.01

Imp. A (EP): [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine


H2 N N

(A)

100 mg

MM 0051.02

Imp. B (EP): Methyl 2-Methoxy-5-sulphamoylbenzoate

H2N O

O S

O O O

(A)

100 mg

MM 0051.03

Imp. C (EP): Ethyl 2-Methoxy-5-sulphamoylbenzoate

H 2N O

O S

O O O

(A)

100 mg

MM 0051.04

Imp. D (EP): 2-Methoxy-5-sulphamoylbenzoic Acid

H2N O

O S

O OH O

(A)

100 mg

MM 0051.05

Imp. E (EP): 2-Methoxy-5-sulphamoylbenzamide

H 2N O

O S

O NH 2 O

(A)

100 mg

MM 0051.06

Imp. F (EP): 1-Ethyl-2-[[(2-methoxy-5sulphamoylbenzoyl)amino]methyl]pyrrolidine 1-Oxide (Sulpiride N-Oxide) Imp. G (EP): (RS)-N-[(1-Ethylpyrrolidin-2-yl)methyl]2-hydroxy-5-sulphamoylbenzamide 5-Sulphamoylsalicylic Acid

O O

NH 2 S

O N H O

(A)
N

100 mg

MM 0051.07

O H2N

O S

O N H OH
O OH OH

(A)
N

100 mg

MM 0051.08

H2N O

O S

(A)

100 mg

MM 0051.09

5-Sulphosalicylic Acid Dihydrate

HO O

O S

O OH OH x 2 H 2O

(C)

100 mg

Sumatriptan Succinate
MM 0310.04 Imp. D (EP) as Maleate: N,N-Dimethyl2-[5-[(methylsulfamoyl)methyl]-1H-indol3-yl]ethanamine N-Oxide Maleate
O O S N H H N x N O O O OH OH

(A)

100 mg

MM 0310.05

Imp. E (EP): [3-(2-Aminoethyl)-1H-indol-5-yl]N-methylmethanesulfonamide

O O S N H

H N

(A)

100 mg

NH2

Suplatast Tosilate
MM 0722.01 Methyl Toluene-4-sulphonate
O S O O

(B)

100 mg

Tamoxifen Citrate
MM 0053.00 Tamoxifen Citrate
O N x HO HO HO O O O OH

(A)

100 mg

216

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Pharmaceutical impurities
Code Product Price Unit

MM 0053.02

Imp. B (EP): 1-[4-(2-Dimethylaminoethoxy) phenyl]-1,2-diphenylbutan-1-ol


OH

(A)
O N

100 mg

MM 0053.14

Imp. C (EP) Z-Isomer: 2-[4-[(Z)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine

on request
O N

MM 0053.15

Imp. C (EP) E-Isomer: 2-[4-[(E)1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine

(A)

50 mg

MM 0053.16

Imp. D (EP) Z-Isomer: 2-[4-[(Z)-1,2-Diphenylprop1-enyl]phenoxy]-N,N-dimethylethanamine

(A)
O N

50 mg

MM 0053.17

Imp. D (EP) E-Isomer: 2-[4-[(E)-1,2-Diphenylprop1-enyl]phenoxy]-N,N-dimethylethanamine

(A)

50 mg

MM 0053.05

Imp. E (EP):2-[2-[(EZ)-1,2-Diphenylbut-1-enyl)phenoxy]N,N-dimethylethanamine
O N

(A)

100 mg

MM 0053.12

Imp. F (EP) as Hydrochloride: 2-[4-[(Z)-1,2-Diphenylbut1-enyl]phenoxy]-N-methylethanamine Hydrochloride

(A)
O N H x HCl

100 mg

MM 0053.07

Imp. G (EP): (2RS)-1-[4-[2-(Dimethylamino)ethoxy]phenyl]2-phenylbutan-1-one


O

(A)
O N

100 mg

MM 0053.08

1,2-Diphenylbutan-1-one

(A)

100 mg

MM 0053.09

1-(4-Methoxyphenyl)-1,2-diphenylbutan-1-ol
O OH

(A)

100 mg

MM 0053.10

(EZ)-1-(4-Hydroxyphenyl)-1,2-diphenylbut-1-ene
OH

(C)

50 mg

MM 0053.18

Tamoxifen N-Oxide
O N O

(A)

100 mg

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217

Pharmaceutical impurities
Code Product Price Unit

Tamsulosin Hydrochloride
MM 0938.00 Tamsulosin Hydrochloride
O O H N O O S x HCl NH2 O
O O O O S NH2 O x HCl

(D)

100 mg

MM 0938.02

Imp. A (EP) as Hydrochloride: 5-[(2R)-2[Bis[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride


O O N

(A)

100 mg

MM 0938.03

Imp. B (EP): 5-[(2R)-2-Aminopropyl]2-methoxybenzenesulfonamide Imp. C (EP) as Hydrochloride: 2-Methoxy-5-[(2R)2-[(2-phenoxyethyl)amino]propyl]benzenesulfonamide Hydrochloride Imp. D (EP) as Hydrochloride: 2-Methoxy5-[(2R)-2-[[2-(2-methoxyphenoxy)ethyl]amino]propyl]benzenesulfonamide Hydrochloride Imp. E (EP): 5-Formyl-2-methoxybenzeneSulfonamide Imp. F (EP) as Hydrochloride: 2-(2-Ethoxyphenoxy)ethanamine Hydrochloride

H2N

O O S NH2 O

(A)

100 mg

MM 0938.04

H N

O O S x HCl NH2 O

(A)

100 mg

MM 0938.05

O O

H N

O O S x HCl NH2 O O O S NH2 O

(A)

100 mg

MM 0938.06

(A)

50 mg

MM 0938.07

(A)
O O NH2 x HCl

100 mg

MM 0938.10

Imp. G (EP) as Racemate Hydrochloride: 5-[(2RS)-2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride (Tamsulosin Racemate Hydrochloride) Imp. H (EP) as Racemate Hydrochloride: (2RS)-N-[2-(2-Ethoxyphenoxy)ethyl]1-(4-methoxyphenyl)propan2-amine Hydrochloride Imp. I (EP): 1-(2-Bromoethoxy)-2-ethoxybenzene

O O

H N

O O S NH2 O

(A)
x HCl

50 mg

MM 0938.01

O O

H N O

(A)
x HCl

100 mg

MM 0938.09

(A)
O O Br

100 mg

Telmisartan
MM 0939.01 Imp. A (EP): 4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazole
N N

(A)

100 mg

NH N

MM 0939.10

Methyl 4'-(Bromomethyl)biphenyl-2-carboxylate

Br

(A)

100 mg

Temazepam
MM 0087.00 Temazepam [Controlled Substance]
Cl N N O OH

(A)

100 mg

MM 0023.01

Imp. A (EP): [5-Chloro-2-(methylamino)phenyl]phenylmethanone (5-Chloro-2-(methylamino)benzophenone)

NH Cl O

(B)

100 mg

218

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Pharmaceutical impurities
Code Product Price
H N Cl N O OH

Unit

MM 0080.00

Imp. B (EP): Oxazepam [Controlled Substance]

(D)

100 mg

Tenofovir Disoproxil Fumarate


MM 1329.00 Tenofovir Disoproxil Fumarate
NH2 N N N N O O P O O O O O O O O x O HO

(A)
O OH

100 mg

Tenoxicam
MM 0084.01 MM 0247.01 Imp. A (EP): Pyridin-2-amine Imp. B (EP): Methyl 4-Hydroxy-2-methyl-2H-thieno[2,3-e] 1,2-thiazine-3-carboxylate 1,1-Dioxide
S OH O
H N O

H2 N N
O O S N O

(B) (A)

100 mg 100 mg

MM 0247.04

Imp. C (EP): N-Methylthiophene-2-carboxamide


S

(A)

100 mg

MM 0247.06

Imp. E (EP): 2-Methylthieno[2,3-d]isothiazol-3(2H)-one 1,1-Dioxide


S

O O S N O

(A)

100 mg

New MM 0247.08

Imp. G (EP): 4-Hydroxy-2-methyl-2H-thieno[2,3-e]1,2-thiazine-3-carboxamide 1,1-Dioxide


S

O O S N NH2 OH O

(A)

50 mg

New MM 0247.09

Imp. H (EP): 3-[(Methylamino)sulfonyl]thiophene-2-carboxylic Acid


S

O O S N H OH O

(A)

50 mg

MM 0247.10

2-(Methoxycarbonyl)-3-thiophenesulfonyl Chloride
S

O O S Cl O O

(A)

100 mg

Terazosin Hydrochloride Dihydrate


MM 0843.00 Terazosin Hydrochloride Dihydrate
N O O N N NH2 N O x HCl x 2 H2O O

(A)

100 mg

MM 0085.04

Imp. A (EP): 2-Chloro-6,7dimethoxyquinazolin-4-amine Imp. B (EP): 1-(4-Hydroxy6,7-dimethoxyquinazolin-2-yl)-4-[[(2RS)tetrahydrofuran-2-yl]carbonyl]piperazine

O O

N N NH2

Cl

(A)

100 mg

MM 0843.02

O N O O N N OH N O

(A)

100 mg

MM 0085.01

Imp. C (EP): 6,7-Dimethoxy2-(piperazin-1-yl)quinazolin-4-amine

NH O O N N NH2 N

(A)

100 mg

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219

Pharmaceutical impurities
Code Product Price
O N O O N N NH2 N x HCl

Unit

MM 0843.04

Imp. D (EP) as Hydrochloride: 1-(4-Amino-6,7dimethoxyquinazolin-2-yl)-4-formylpiperazine Hydrochloride

(A)

100 mg

MM 0085.03

Imp. E (EP): 2,2'-(Piperazine-1,4-diyl)bis(6,7dimethoxyquinazolin-4-amine)


N O O N N NH2 N

NH2 N N O O

(D)

100 mg

MM 0085.00

Imp. K (EP) as Hydrochloride: Prazosin Hydrochloride


O O N N NH2 N

O N O x HCl

(A)

100 mg

MM 0085.02

Imp. L (EP): 1-(Furan-2-ylcarbonyl)piperazine


N HN

(A)
O

100 mg

MM 0085.05

Imp. M (EP): 1,4-Bis(furan-2ylcarbonyl)piperazine

O O N O N O

(A)

100 mg

MM 0843.15

Imp. N (EP): 1-[[(2RS)-Tetrahydrofuran-2-yl]carbonyl] piperazine


HN

O N O
O O N O N O

(A)

100 mg

MM 0843.16

Imp. O (EP): 1,4-Bis[(tetrahydrofuran-2-yl)carbonyl] piperazine

(A)

100 mg

Terbinafine Hydrochloride
MM 0696.00 Terbinafine Hydrochloride
N x HCl

(A)

100 mg

MM 0696.02

Imp. A (EP) as Hydrochloride: N-Methyl-C-(naphthalen1-yl)methanamine Hydrochloride (Secundary Amine Hydrochloride) Imp. B (EP) as Hydrochloride: (2Z)-N,6,6-TrimethylN-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine Hydrochloride (cis-Terbinafine Hydrochloride) Imp. C (EP) as Hydrochloride: (2E)N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept2-en-4-yn-1-amine Hydrochloride (trans-isoTerbinafine Hydrochloride) Imp. D (EP) as Hydrochloride: (2E)-N,6,6-TrimethylN-[(4-methylnaphthalen-1-yl)methyl]hept-2-en-4-yn1-amine Hydrochloride (4-Methylterbinafine Hydrochloride) N-Demethylterbinafine Hydrochloride
N H

(A)
NH x HCl

100 mg

MM 0696.03

(D)
N x HCl

100 mg

MM 0696.04

x HCl

(D)

100 mg

MM 0696.05

(D)
N x HCl

100 mg

MM 0696.07

(D)
x HCl

50 mg

MM 0696.10

Imp. F (EP) as Hydrochloride: (2Z)N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept2-en-4-yn-1-amine Hydrochloride (cis-Isoterbinafine Hydrochloride)

(D)
N x HCl

50 mg

Terbutaline Sulphate
MM 0708.01 Imp. A (EP): 3,5-Dihydroxybenzoic Acid (-Resorcylic Acid)
O HO OH

(B)

100 mg

OH

220

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Pharmaceutical impurities
Code Product Price
OH HO N OH x 1/2 H2SO4

Unit

MM 0708.03

Imp. B (EP) as Hemisulphate: (4RS)2-(1,1-Dimethylethyl)-1,2,3,4-tetrahydroisoquinoline4,6,8-triol Hemisulphate

(D)

100 mg

Terfenadine
MM 0055.00 Terfenadine
N OH OH

(A)

500 mg

MM 0055.04

Imp. A (EP): 1-[4-(1,1-Dimethylethyl)phenyl]4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butan1-one (Terfenadone)


OH

(A)
N O

100 mg

MM 0055.07

Imp. B (EP): (1RS)-1-[4-(1,1-Dimethylethyl)phenyl]4-[4-(diphenylmethyl)piperidin-1-yl]butan-1-ol


N OH

(A)

100 mg

MM 0055.12

Imp. E (EP) as Hydrochloride: 1-[(4RS)4-[4-(1,1-Dimethylethyl)phenyl]4-hydroxybutyl]piperidine-4-carboxylic Acid Hydrochloride Imp. G (EP): [1-[4-[4-(1,1-Dimethylethyl)phenyl]but-3-enyl]piperidin-4yl]diphenylmethanol

(A)
N HO O x HCl OH

100 mg

MM 0055.09

(A)
N

100 mg

OH

MM 0055.10

Imp. H (EP): [1-[4-[4-(1,1-Dimethylethyl)phenyl]butyl]piperidin4-yl]diphenylmethanol


OH

(A)
N

100 mg

MM 0055.02

Imp. I (EP): Diphenyl(piperidin-4-yl)methanol (Azacyclonol)


OH

NH

(B)

100 mg

MM 0055.03

Imp. J (EP): Ethyl 1-[(4RS)4-[4-(1,1-Dimethylethyl)phenyl]-4-hydroxybutyl]piperidine-4-carboxylate


O O

(A)
N OH

100 mg

Testosterone
MM 0323.00 Testosterone
OH

(A)

500 mg

MM 0323.01

Imp. A (EP): Androst-4-ene-3,17-dione (Androstenedione)


O

(A)

100 mg

MM 0323.02

Imp. B (EP): 3-Ethoxyandrosta-3,5-dien-17-one (Androstenedione Ethylenolether)


O

(A)

100 mg

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221

Pharmaceutical impurities
Code Product Price
OH

Unit

MM 0323.03

Imp. C (EP): 17-Hydroxyandrost-4-en-3-one (Epitestosterone)


O

(A)

100 mg

MM 0323.04

Imp. D (EP): Androst-4-ene-3,17-diol (4-Androstenediol)


HO

OH

(A)

100 mg

MM 0323.05

Imp. E (EP): 3-Oxoandrost-4-en-17-yl Acetate (Testosterone Acetate)

O O

(A)

100 mg

MM 0565.00

Imp. F (EP): 17-Hydroxy-5-androstan-3-one (Androstanolone, Stanolone)


O H

OH

(A)

250 mg

MM 0323.07

Imp. G (EP): Androsta-1,4-diene-3,17-dione (Androstadienedione)


O

(A)

100 mg

MM 0864.00

Imp. H (EP): 17-Hydroxyandrosta-1,4-dien-3-one (Boldenone)


O

OH

(A)

100 mg

MM 0323.12

Imp. I (EP): 17-Hydroxyandrosta-4,6-dien-3-one (6-testosterone)


O

OH

(A)

100 mg

MM 0323.13

Imp. J (EP): 3-Methoxyandrosta-3,5-dien17-one (Androstenedione Methylenolether)


O

(A)

100 mg

Testosterone Benzoate
MM 0493.00 Testosterone Benzoate
O O

(D)

250 mg

MM 0323.00

Testosterone

OH

(A)

500 mg

MM 0278.01

Benzoic Acid

O OH

(B)

100 mg

Testosterone Enantate
MM 1119.00 Testosterone Enantate
O O

(A)

100 mg

MM 0863.08

Imp. B (EP): 3-Oxoandrost-4-en-17-yl Hexanoate (Testosterone Caproate)

O O

(A)

100 mg

222

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Pharmaceutical impurities
Code Product Price
OH

Unit

MM 0323.00

Imp. D (EP): 17-Hydroxyandrost-4-en-3-one (Testosterone)


O

(A)

500 mg

Testosterone Isocaproate
MM 0863.00 Testosterone Isocaproate
O O

(A)

100 mg

MM 0323.00

Imp. A (EP): Testosterone

OH

(A)

500 mg

MM 0323.05

Imp. B (EP): 3-Oxoandrost-4-en-17-yl Acetate (Testosterone Acetate)

O O

(A)

100 mg

MM 0897.00

Imp. C (EP): Testosterone Propionate


O

(A)

100 mg

MM 0863.07

Imp. D (EP): 3-Oxoandrost-4-en-17-yl 2Methylpropanoate (Testosterone Isobutyrate)

O O

(A)

100 mg

MM 0863.08

Imp. E (EP): 3-Oxoandrost-4-en-17-yl Hexanoate (Testosterone Caproate)

O O

(A)

100 mg

MM 1119.00

Imp. F (EP): Testosterone Enantate


O

(A)

100 mg

MM 0863.09

Imp. G (EP): 3-Oxoandrost-4-en-17-yl 4-Methylpentanoate (Epitestosterone Isocaproate)

O O

(A)

100 mg

Testosterone Phenylpropionate
MM 1394.00 Testosterone Phenylpropionate
O O

(A)

100 mg

Testosterone Propionate
MM 0897.00 Testosterone Propionate
O O

(A)

100 mg

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223

Pharmaceutical impurities
Code Product Price
O O

Unit

MM 0323.05

Imp. A (EP): 3-Oxoandrost-4-en-17-yl Acetate (Testosterone Acetate)

(A)

100 mg

MM 0863.07

Imp. B (EP): 3-Oxoandrost-4-en-17-yl 2-Methylpropanoate (Testosterone Isobutyrate)

O O

(A)

100 mg

MM 0323.00

Imp. C (EP): Testosterone

OH

(A)

500 mg

MM 0897.04

Imp. D (EP): 3-Oxoandrosta-1,4-dien-17-yl Propanoate

O O

(C)

50 mg

MM 0897.05

Imp. E (EP): 3-Oxoandrosta-4,6-dien-17-yl Propanoate

O O

(A)

100 mg

Tetracaine Hydrochloride
MM 0504.00 Tetracaine Hydrochloride
N H O O N x HCl

(A)

500 mg

MM 0094.03

Imp. A (EP): 4-Aminobenzoic Acid


H2N

O OH

(B)

100 mg

MM 0504.01

Imp. B (EP): 4-(Butylamino)benzoic Acid


N H

O OH

(A)

100 mg

MM 0504.04

Imp. C (EP): Methyl 4-(Butylamino)benzoate


N H

O O

(A)

100 mg

MM 0504.02

Tetracaine N-Oxide
N H

O O N

(A)

100 mg

Tetracycline Hydrochloride
MM 0452.00 Tetracycline Hydrochloride
OH O H HO OH O OH H N O NH2 OH x HCl

(A)

500 mg

Tetramisole Hydrochloride
MM 0703.00 Tetramisole Hydrochloride
N N S x HCl

(A)

500 mg

Tetrazepam
MM 0091.00 Tetrazepam [Controlled Substance]
Cl N N O

(A)

100 mg

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Pharmaceutical impurities
Code Product Price
H N Cl N O

Unit

MM 0091.06

Imp. B (EP): 7-Chloro-5-cyclohexyl-1,3-dihydro-2H1,4-benzodiazepin-2-one

(A)

100 mg

MM 0091.07

Imp. C (EP): 7-Chloro-5-cyclohexyl-1-methyl1,3-dihydro-2H-1,4-benzodiazepin-2-one


Cl

N N

(A)

100 mg

MM 0091.03

Imp. E (EP): 7-Chloro-5-(cyclohex-1-enyl)-1,3dihydro-2H-1,4-benzodiazepin-2-one (Nortetrazepam)

H N Cl N

(A)

100 mg

MM 0091.04

6-Chloro-2-methyl-4-oxo-4H-3,1-benzoxazine
Cl

N O O

(A)

100 mg

MM 0091.52

2-Bromo-4'-chloro-2'-(cyclohexylcarbonyl)acetanilide
Cl

O NH O

Br

on request

Tetryzoline Hydrochloride
MM 0088.00 Tetryzoline Hydrochloride
HN N x HCl

(A)

100 mg

MM 0088.03

Imp. A (EP): (1RS)-1,2,3,4-Tetrahydronaphthalene-1carbonitrile (-Cyanotetraline) 1,2,3,4-Tetrahydro-1-naphthalenecarboxylic Acid


O

(A)

100 mg

MM 0088.02

OH

(A)

100 mg

MM 0088.04

Methyl 1,2,3,4-Tetrahydro-1-naphthalenecarboxylate

(A)

100 mg

MM 0088.05

N-(2-Aminoethyl)-1,2,3,4-tetrahydronaphthalene-1-yl-carboxamide Hydrochloride ((1,2,3,4-Tetrahydro-1-naphthyl)formylethylenediamine Hydrochloride) 2-(1,2,3,4-Tetrahydro-1-naphthalenyl)-1H-imidazole Hydrochloride

H N

NH 2 x HCl

(A)

100 mg

MM 0088.06

HN

N x HCl

(A)

100 mg

Thalidomide
MM 0940.00 Thalidomide
O N NH O O O

(A)

100 mg

Thebaine
New MM 0244.00 Thebaine [Controlled Substance]
N

(A)

100 mg

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225

Pharmaceutical impurities
Code Product Price Unit

Theobromine
MM 0577.00 Theobromine
HN O N O N N

(A)

500 mg

Theophylline
MM 0176.00 Theophylline
N O N O H N N

(A)

500 mg

MM 0494.00

Imp. A (EP): Caffeine


N O

O N N
O HN O N
O N O N
O N H HN N N H

(A)
N

500 mg

MM 0176.03

Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione (3-Methylxanthine)

H N N

(A)

100 mg

MM 0176.02

Imp. C (EP): N-(6-Amino-1,3-dimethyl-2,4dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)formamide

H N O NH2

(A)

100 mg

MM 0176.01

Imp. D (EP): N-Methyl-5-(methylamino)-1H-imidazole4-carboxamide (Theophyllidine)

(A)

100 mg

MM 0603.00

Imp. F (EP): Etofylline


N O

O N N N

OH

(A)

500 mg

MM 0176.04

1-Methylxanthine
N O

O N N H O HN O N H N N N H

on request

MM 0176.05

7-Methylxanthine

(A)

100 mg

Theophylline-Ethylenediamine
MM 0494.00 Imp. A (EP): Caffeine
N O N
O HN O N
O N O N O N H HN N N H
OH N N N
O HN O N N N

O N N

(A)

500 mg

MM 0176.03

Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione (3-Methylxanthine)

H N N

(A)

100 mg

MM 0176.02

Imp. C (EP): N-(6-Amino-1,3-dimethyl-2,4dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)formamide Imp. D (EP): N-Methyl-5-(methylamino)-1Himidazole-4-carboxamide (Theophyllidine)

H N O NH2

(A)

100 mg

MM 0176.01

(A)

100 mg

MM 0603.00

Imp. F (EP): Etofylline


N O

(A)

500 mg

MM 0577.00

Imp. G (EP): Theobromine

(A)

500 mg

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Pharmaceutical impurities
Code Product Price Unit

Thiamazole
MM 0889.00 MM 0889.02 MM 0889.03 MM 0889.04 Thiamazole Imp. B (EP): 1-Methyl-1H-imidazole Imp. C (EP): 1-Methyl-2-(methylsulphanyl)-1H-imidazole Imp. C (EP) as Hydrochloride: 1-Methyl-2-(methylsulphanyl)1H-imidazole Hydrochloride
S N N x HCl
S N NH

(A) (B)

500 mg 100 mg 100 mg 100 mg

N N
S N N

(A) (A)

Thiamine Hydrochloride
MM 0049.00 Thiamine Hydrochloride (Vitamin B1)
HO S N+ ClN N NH2 x HCl

(A)

500 mg

New MM 0049.07

Imp. A (EP) as Chloride: 3-[(4-Amino-2methylpyrimidin-5-yl)methyl]-4-methyl-5[2-(sulfonatooxy)ethyl]thiazolium Chloride (Thiamine Chloride Sulfate Ester) Imp. C (EP) as Chloride Hydrochloride: 3-[(4Amino-2-methylpyrimidin-5-yl)methyl]-5-(2chloroethyl)-4-methylthiazolium Chloride Hydrochloride (Chlorothiamine Chloride Hydrochloride) Imp. E (EP): 3-[(4-Amino-2-methylpyrimidin-5-yl) methyl]-5-(2-hydroxyethyl)-4-methylthiazol-2(3H)-thione (Thioxothiamine) 5-(2-Hydroxyethyl)-4-methylthiazole 4-Amino-5-hydroxymethyl-2-methylpyrimidine Hydrochloride
Cl

S O HO S O O
S N+ Cl-

N N+ ClN N NH2 x HCl

(A)
N

100 mg

NH2

New MM 0049.09

(A)

100 mg

MM 0049.05

S HO N

N N NH2

(A)

100 mg

MM 0049.02 MM 0049.04

N S OH

(A) (A)

100 mg 100 mg

N N

OH x HCl NH 2

Thiamphenicol
MM 0737.00 Thiamphenicol
O Cl Cl N H OH O O S

(A)

500 mg

OH

Thioctic Acid
MM 0127.00 Thioctic Acid
S S O OH

(A)

500 mg

Thiopental Sodium and Sodium Carbonate


New MM 1312.03 Imp. C (EP): 5-Ethyl-5-(1-ethylpropyl)-2-thioxo-2,3dihydropyrimidine-4,6(1H,5H)-dione
O H N NH O S

(A)

50 mg

Thioridazine Hydrochloride
New MM0116.00 Thioridazine Hydrochloride
N S S N x HCl

(A)

250 mg

MM 0116.05

2-Methylthiophenothiazine
NH S S

(A)

100 mg

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227

Pharmaceutical impurities
Code Product Price Unit

Tiabendazole
MM 0602.00 MM 0602.01 Tiabendazole Imp. A (EP): Benzene-1,2-diamine
H N N N NH2 NH2 S

(A) (C)

500 mg 100 mg

Tiamulin Hydrogen Fumarate


MM 0394.00 Tiamulin Hydrogen Fumarate
N S O O H O x OH HO O
O HO O OH

(A)

100 mg

HO

MM 0460.10 MM 0394.04

Fumaric Acid Imp. A (EP): (3aS,4R,5S,6S,8R,9R,9aR,10R)6-Ethenyl-5,8-dihydroxy-4,6,9,10-tetramethyloctahydro-3a,9-propano-3aH-cyclopentacycloocten-1(4H)-one (Mutilin) Imp. B (EP) as Hydrochloride: 2-(Benzylsulfanyl)N,N-diethylethanamine Hydrochloride Imp. C (EP) as Dihydrochloride: 2,2'-(Disulfane1,2-diyl)bis(N,N-diethylethanamine) Dihydrochloride Imp. J (EP): (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl5-hydroxy-4,6,9,10-tetramethyl-1-oxo-decahydro-3a,9propano-3aH-cyclopentacyclo-octen-8-yl Acetate (Mutilin 14-Acetate) Imp. P (EP): (3aS,4R,5S,6S,8R,9R,9aR,10R)-6Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propano-3aH-cyclopentacycloocten-8-yl [(Phenylsulphonyl)oxy]acetate Imp. E (EP) as Hydrogen Fumarate: (3aS,4R,6S,8R,9R,9aR,10R)-6Ethenyl-4,6,9,10-tetramethyl-1,5dioxodecahydro-3a,9-propano3aH-cyclopenta-cycloocten-8-yl [[2-(Diethylamino)ethyl]sulfanyl]acetate Hydrogen Fumarate (11-Oxotiamulin Hydrogen Fumarate)
O O S O

(B) (A)

100 mg 100 mg

HO H

HO

New MM 0394.05

(A)
N S x HCl

50 mg

MM 0394.06

(A)
N S S N x 2 HCl
O O H O

50 mg

MM 0394.13

(A)

50 mg

HO

MM 0394.18

O O H

(A)

50 mg

HO

New MM 0394.23

(A)
N S O O H O

50 mg

x O HO O

OH

Tiapride Hydrochloride
MM 0073.01 MM 1331.04 Imp. C (EP): N,N-Diethylethane-1,2-diamine
H2N N

(B)
O O S O N H OH N

100 mg 100 mg

N-[2-(Diethylamino)ethyl]-2-hydroxy5-(methylsulfonyl)benzamide

(A)

Ticlopidine Hydrochloride
MM 0150.00 Ticlopidine Hydrochloride
N Cl S x HCl

(A)

500 mg

MM 0150.12 MM 0150.06

Imp. A (EP): Thieno[3,2-c]pyridine


N

(A) (A)

100 mg 100 mg

Imp. B (EP): 6,7-Dihydrothieno[3,2-c]pyridin-4(5H)-one


HN O

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Pharmaceutical impurities
Code Product Price Unit

MM 0150.01

Imp. C (EP) as Hydrochloride: (2-Chlorophenyl)methanamine Hydrochloride


Cl

(A)
NH2 x HCl

100 mg

MM 0150.07 MM 0150.13

Imp. D (EP) as Hydrochloride: 5-Benzyl4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride Imp. E (EP) as Chloride: 5-(2-Chlorobenzyl)thieno[3,2-c]pyridinium Chloride
Cl

S N

x HCl

(A) (A)

100 mg 50 mg

S N+ Cl-

MM 0150.14

Imp. F (EP) as Hydrochloride: 6-(2-Chlorobenzyl)-4,5,6,7-tetrahydrothieno[2,3-c]pyridine Hydrochloride Imp. G (EP) as Hydrochloride: 5-(3-Chlorobenzyl)4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride Imp. H (EP) as Hydrochloride: 5-(4-Chlorobenzyl)4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride Imp. I (EP) as Hydrochloride: N-(2-Chlorobenzyl)2-(thiophen-2-yl)ethanamine Hydrochloride
Cl

(A)
N Cl
S N
S N

50 mg

x HCl

MM 0150.08 MM 0150.09 MM 0150.11

x HCl

(A) (C) (A)

100 mg 50 mg 100 mg

Cl

x HCl

S NH Cl x HCl

MM 0150.10

Imp. J (EP) as Dihydrochloride: N,N'Bis(2-chlorobenzyl)ethane-1,2-diamine Dihydrochloride Imp. L (EP): 5-(2-Chlorobenzyl)-6,7-dihydrothieno [3,2-c]pyridin-4(5H)-one

NH Cl

N H Cl

(A)
x 2 HCl

100 mg

MM 0150.15

S N Cl O

(A)

50 mg

MM 0150.04

5-(2-Chlorobenzoyl)-4,5,6,7-tetrahydrothieno [3,2-c]pyridine
Cl O

S N

(A)

100 mg

Tilidine Hydrochloride Hemihydrate


MM 0134.00 Tilidine Hydrochloride Hemihydrate [Controlled Substance]
N x HCl x 1/2 H2O O O and enantiomer

(A)

100 mg

MM 0134.01

Imp. A (EP): Ethyl (1RS,2RS)-2-(Dimethylamino)-1phenylcyclohex-3-enecarboxylate (cis-Tilidine) [Controlled Substance]

(D)

100 mg

O O and enantiomer

MM 0134.03

Imp. D (EP) as Hydrochloride: Ethyl (2RS)-3Dimethylamino-2-phenylpropanoate Hydrochloride

N O O x HCl

(A)

100 mg

MM 0134.05

Tilidine [Controlled Substance]

(A)

100 mg

O O and enantiomer

Timolol Maleate
MM 0440.00 Timolol Maleate
N S N N O O
N S N N O OH

OH O

H N x

O OH OH

(A)

250 mg

MM 0440.04

Imp. D (EP): 4-(Morpholin-4-yl)-1,2,5-thiadiazol-3-ol

(A)

100 mg

MM 0440.03

N-Benzyl-tert-butylamine
HN

(B)

100 mg

MM 0440.05

3-Hydroxy-4-morpholino-1,2,5-thiadiazole 1-Oxide

N O S N

OH N O

(A)

100 mg

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229

Pharmaceutical impurities
Code Product Price Unit

MM 0440.02

(S)-Isotimolol
HO N S N N O O N H

(A)

100 mg

Tinidazole
MM 0012.02 Imp. A (EP): 2-Methyl-5-nitro-1H-imidazole (2-Methyl-4-nitroimidazole)
O2 N NH N

(B)

100 mg

Tioconazole
MM 0281.01 Imp. D (EP): (1RS)-1-(2,4-Dichlorophenyl)-2(1H-imidazol-1-yl)ethanol
Cl HO N N Cl

(A)

100 mg

Tiotropium Bromide Monohydrate


MM 1293.05 Imp. E (EP): Methyl 2-Hydroxy-2,2-dithiophen-2-ylacetate
S S O O OH

(A)

100 mg

MM 1293.06

Imp. F (EP): Dithiophen-2-ylmethanone


S

S O

(A)

100 mg

Tizanidine Hydrochloride
MM 0887.04 N-Acetyltizanidine
Cl N N O NH N S N

(A)

50 mg

MM 0887.05

1-Acetylimidazolidine-2-thione
N H

O N S

(A)

50 mg

Tocopheryl Acetate (all-rac-a-)


New MM 1381.00 all-rac--Tocopheryl Acetate
O O O

(A)

250 mg

Tolazoline Hydrochloride
MM 0585.00 Tolazoline Hydrochloride
HN N x HCl

(A)

500 mg

Tolbutamide
New MM 1089.00 Tolbutamide
O O O S N N H H

(A)

100 mg

MM 0325.01

Imp. A (EP): (4-Methylphenyl)sulfonamide (Toluenesulfonamide; 4-Methylbenzene-

O O S NH2

(C)

100 mg

Tolnaftate
MM 0731.01 MM 0731.04 Imp. A (EP): Naphthalen-2-ol (-Naphthol)
HO

(A) (A)
NH

100 mg 100 mg

Imp. D (EP): N,3-Dimethylaniline (N-Methyl-m-toluidine)

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Pharmaceutical impurities
Code Product Price
S Cl O

Unit

MM 0731.03

O-Naphthalen-2-yl Chlorothioformate

(A)

100 mg

Tolmetin Sodium Dihydrate


MM 0571.00 Tolmetin Sodium Dihydrate
O N O ONa x 2 H2O

on request

Tolterodine Tartrate
MM 0900.00 Tolterodine Tartrate
OH x N OH HO O OH O OH

(A)

100 mg

Topiramate
MM 1348.00 Topiramate
O O O O O O O O S NH2

(A)

100 mg

Torasemide, Anhydrous
MM 1283.02 Imp. B (EP): 4-[(3-Methylphenyl)amino]pyridine-3-Sulfonamide
N O O S NH2 NH

(A)

100 mg

MM 1283.03

Imp. C (EP): 1-Ethyl-3-[[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl]urea

O O O S N N H H NH

(A)

50 mg

MM 1283.04

Imp. D (EP): 1-Butyl-3-[[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl]urea

O O O S N N H H NH

(A)

50 mg

New MM 1283.05

Imp. E (EP): Ethyl [[4-[(3-Methylphenyl)amino]pyridin3-yl]sulfonyl]carbamate

O O O S N O H NH

(A)

100 mg

Tramadol Hydrochloride
MM 0007.00 Tramadol Hydrochloride
O OH N and enantiomer x HCl

(A)

500 mg

MM 0007.01

Imp. A (EP) as Hydrochloride: (1RS,2SR)2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride Imp. B (EP) as Hydrochloride: [2-(3-Methoxyphenyl)cyclohex-1-enyl]-N,Ndimethylmethanamine Hydrochloride Imp. C (EP) as Hydrochloride: (1RS)-[2-(3-Methoxyphenyl)cyclohex-2-enyl]-N,N-dimethylmethanamine Hydrochloride

O OH N and enantiomer x HCl

(A)

100 mg

MM 0007.03

(A)
x HCl N

100 mg

MM 0007.04

(A)
x HCl N

100 mg

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231

Pharmaceutical impurities
Code Product Price
HO OH N and enantiomer x HCl

Unit

MM 0007.06

Imp. D (EP) as Hydrochloride: (1RS,2RS)-2[(Dimethylamino)methyl]-1-(3-hydroxyphenyl)cyclohexanol Hydrochloride Imp. E (EP) as Hydrochloride: (2RS)2-[(Dimethylamino)methyl]cyclohexanone Hydrochloride 3-Bromoanisole N-Desmethyltramadol Hydrochloride
O

(A)

100 mg

MM 0007.02

O N x HCl

(A)

100 mg

MM 0007.05 MM 0007.07

Br

(B) (A)

100 mg 100 mg

OH NH and enantiomer

x HCl

MM 0007.08

N,O-Didesmethyltramadol Hydrochloride

HO OH N H and enantiomer x HCl

(A)

100 mg

MM 0007.09 MM 0007.11

3-Methoxyphenol Tramadol N-Oxide


O

OH

(B) (A)

100 mg 100 mg

OH N and enantiomer O

MM 0007.50

[2-(3-Hydroxyphenyl)cyclohex-1-enyl]-N,Ndimethylmethanamine Hydrochloride

HO

(A)
x HCl N

100 mg

Tranexamic Acid
MM 0330.00 Tranexamic Acid
H2 N O OH

(A)

500 mg

MM 0330.04

Imp. D (EP): 4-Aminomethylbenzoic Acid


H2 N

O OH

(B)

100 mg

Trazodone Hydrochloride
MM 0421.00 Trazodone Hydrochloride
N O N N N N Cl x HCl

(A)

100 mg

MM 0421.13

Imp. A (BP) as Hydrochloride: 4-(3-Chloro-phenyl)-1-[3-(3-oxo-2,3dihydro-1,2,4-triazolo[4,3-a]pyridin-2yl)propyl]piperazine N1-oxide Hydrochloride (Trazodone N-Oxide Hydrochloride) Imp. B (BP): 2-[3-(4-Phenylpiperazin-1-yl)propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one

(A)
N O N N N O N Cl x HCl

50 mg

MM 0421.02

(A)
N O N N N N

50 mg

MM 0421.03

Imp. C (BP) as Dihydrochloride: 2-[3-[4-(4-Chlorophenyl)piperazin-1-yl]propyl]1,2,4-triazolo[4,3-a]pyridin-3(2H)-one Dihydrochloride Imp. D (BP) as Hydrochloride: 2-3[4-(3-Bromo-phenyl)piperazin-1-yl]propyl-1,2,4-triazolo[4,3-a]-pyridin3(2H)-one Hydrochloride Imp. F (BP) as Hydrochloride: 1-(3-Chlorophenyl)4-(3-chloropropyl)piperazine Hydrochloride

Cl N N N N x 2 HCl

on request

N O

MM 0421.04

(A)
N O N N N N Br x HCl

50 mg

MM 0421.06

(A)
N Cl N Cl x HCl

100 mg

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Pharmaceutical impurities
Code Product Price Unit

MM 0421.07

Imp. G (BP) as Hydrochloride: 3-[4-(3Chlorophenyl)piperazin-1-yl]propyl Isobutyl Ether Hydrochloride Imp. H (BP) as Dihydrochloride: 1,3-Bis-[4-(3-chlorophenyl)piperazin-1-yl]propane Dihydrochloride 3-[4-(3-Chlorophenyl)piperazin-1-yl]propanol
Cl

(D)
N O N Cl x HCl

50 mg

MM 0421.08

(A)
N N N N Cl x 2 HCl

100 mg

MM 0421.10

(A)
N HO N Cl

100 mg

MM 0421.11

1,2,4-Triazolo-[4,3-a]pyridine-3(2H)-one
N O

N NH

(A)

100 mg

MM 0421.12

1,4-Bis-3-chlorophenylpiperazine
N Cl N Cl

on request

Trenbolone
New MM 1377.00 Trenbolone
OH

(A)

100 mg

Triacetin
MM 0966.00 Triacetin
O O O O O O

(A)

500 mg

Triamcinolone
MM 0198.01 Triamcinolone
HO O OH

(A)

250 mg

OH OH F

MM 0198.02

Imp. A (EP): 9-Fluoro-11,17-dihydroxy-3,20dioxopregna-1,4-diene-16,21-diyl Diacetate (Triamcinolone 16,21-Diacetate)

O O HO O

(A)

100 mg

OH O F O OH

MM 0508.03

Imp. C (EP): 9-Fluoro-11,16,17,21-tetrahydroxypregn4-ene-3,20-dione (Pretriamcinolone)

O HO

on request

OH OH F

Triamcinolone Acetonide
MM 0198.00 Triamcinolone Acetonide
HO O O O F O OH

(A)

250 mg

MM 0198.01

Imp. A (EP): 9-Fluoro-11,16,17,21-tetra-

hydroxypregna-1,4-diene-3,20-dione (Triamcinolone)
O

O HO

OH OH OH

(A)

250 mg

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233

Pharmaceutical impurities
Code Product Price
O O HO O OH O F O O

Unit

MM 0198.02

Triamcinolone 16,21-Diacetate

(A)

100 mg

MM 0198.05

Imp. C (Pharmeuropa): 9-Fluoro-11,21,21trihydroxy-16,17-(1-methylethylidenedioxy)pregna-1,4-diene-3,20-dione (Triamcinolone Acetonide 21-Aldehyde Hydrate)


O

O HO O

OH OH O

(A)

100 mg

Triamcinolone Hexacetonide
MM 0306.00 Triamcinolone Hexacetonide
O HO O O F O O O

(A)

100 mg

MM 0198.00

Imp. A (EP): Triamcinolone Acetonide


HO

O O

OH

(A)

250 mg

O F O

MM 0198.01

Triamcinolone
HO

OH OH OH

(A)

250 mg

F O

Triamterene
MM 0269.00 Triamterene
H2 N N N N N NH2 NH2

(A)

500 mg

MM 0269.02

Imp. A (EP): 5-Nitrosopyrimidine-2,4,6-triamine (Nitrosotriaminopyrimidine)


H2N

NH2 N N
N N N N NH2

NO NH2
NH2

(B)

100 mg

MM 0269.01

Sodium Hydroxytriamterene Sulphate


O NaO S O O

H2 N

(B)

10 mg

Triazolam
New MM 1363.00 Triazolam [Controlled Substance]
N Cl N Cl N N

(A)

100 mg

Tributyl Acetylcitrate
MM 0499.00 Tributyl Acetylcitrate
O O O O HO O O O O O O O O O O O O O O O O

on request

MM 0499.01

Imp. A (EP): Tributyl 2-Hydroxypropane1,2,3-tricarboxylate (Tributyl Citrate)

(C)

100 mg

MM 0499.02

Imp. B (EP) (E-Isomer): Tributyl (E)-Propene1,2,3-tricarboxylate (Tributyl (E)-Aconitate)

(A)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Triclabendazole
MM 0313.00 Triclabendazole
Cl Cl O Cl H N S N

(D)

100 mg

Triclosan
MM 0610.00 Triclosan
Cl Cl O Cl OH

(A)

500 mg

Trihexyphenidyl Hydrochloride
MM 0237.00 Trihexyphenidyl Hydrochloride
OH N x HCl

(A)

500 mg

MM 0237.03

Imp. A (EP) as Hydrochloride: 1-Phenyl-3(piperidin-1-yl)propan-1-one Hydrochloride Acetophenone

O N x HCl

(A)

100 mg

MM 0237.01

(B)

100 mg

MM 0237.04

Trihexyphenidyl N-Oxide
OH O N

(C)

50 mg

Trimebutine
MM 0417.00 Trimebutine
N O O O O O

(A)

500 mg

MM 0417.05

Trimebutine Maleate
O N

O O x O O

O OH OH O
N x HCl

(A)

500 mg

MM 0417.01

Imp. A (EP) as Hydrochloride: (2RS)-2(Dimethylamino)-2-phenylbutanol Hydrochloride

(A)

100 mg

HO

MM 0093.13

Imp. B (EP): 3,4,5-Trimethoxybenzoic Acid

O O O O OH

(B)

100 mg

MM 0093.11

Imp. C (EP): Methyl 3,4,5-Trimethoxybenzoate

O O O O O

(A)

100 mg

MM 0417.11

Imp. D (EP): (1RS)-1-[(Dimethylamino)-methyl]1-phenylpropyl 3,4,5-Trimethoxybenzoate

N O O O O O

(A)

50 mg

MM 0417.07

Imp. E (EP) as Hydrochloride: (2RS)-2-(Methylamino)-2-phenylbutyl 3,4,5-Trimethoxy-benzoate Hydrochloride (N-Desmethyltrimebutine Hydrochloride) 1-Dimethylaminomethyl-1-phenyl-1-propanol Hydrochloride (alpha-[(Dimethylamino)methyl]-alphaethyl-benzenemethanol Hydrochloride)

O O O O O

H N x HCl

(A)

50 mg

MM 0417.10

HO

N x HCl

(A)

100 mg

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235

Pharmaceutical impurities
Code Product Price Unit

Trimeprazine Tartrate
MM 0958.00 Trimeprazine Tartrate
N S 2
N N S O O

N x HO O

OH

O OH

(A)

500 mg

OH

MM 0957.00

Trimeprazine Sulphone (Oxomemazine)

(A)

100 mg

MM 0958.02

Trimeprazine Sulphoxide Hydrochloride


N S O

N x HCl

(A)

100 mg

MM 0958.04

Trimeprazine Sulphone N-Oxide Hydrochloride (Oxomemazine N-Oxide Hydrochloride)


N S O O

(A)
x HCl

100 mg

Trimetazidine Dihydrochloride
MM 0539.00 Trimetazidine Dihydrochloride
N HN O O O x 2 HCl

(A)

100 mg

MM 0539.01

Imp. A (EP) as Dihydrochloride: 1-(3,4,5Trimethoxybenzyl)piperazine Dihydrochloride


HN

O x 2 HCl O O

(A)

100 mg

MM 0539.02

Imp. B (EP): 1,4-Bis(2,3,4-trimethoxybenzyl)piperazine

O O O O N N O O

(A)

100 mg

MM 0539.03

Imp. C (EP): 2,3,4-Trimethoxybenzaldehyde


O

O O O

(B)

100 mg

MM 0539.04

Imp. D (EP): (2,3,4-Trimethoxyphenyl)methanol


HO

O O O

(A)

100 mg

MM 0539.05

Imp. E (EP) as Dihydrochloride: 1-(2,4,5Trimethoxybenzyl)piperazine Dihydrochloride


HN

O N O O x 2 HCl

(A)

100 mg

MM 0539.06

Imp. F (EP) as Dihydrochloride: 1-(2,4,6-Trimethoxybenzyl)piperazine Dihydrochloride


HN

O N O O x 2 HCl

(A)

100 mg

MM 0539.07 MM 0539.09

Imp. G (EP) as Hexahydrate: Piperazine Hexahydrate


HN

NH

x 6 H2O

(B) (A)

100 mg 100 mg

Imp. H (EP): Ethyl 4-(2,3,4-Trimethoxybenzyl)piperazine-1-carboxylate


O O N

O N O O

MM 0539.10

Imp. I (EP) as Dihydrochloride: 1-Methyl-4(2,3,4-trimethoxybenzyl)piperazine Dihydrochloride (N-Methyltrimetazidine Dihydrochloride) 1-Formyl-4-(2,3,4-trimethoxybenzyl)piperazine Hydrochloride


O

O N N O O x 2 HCl

(A)

100 mg

MM 0539.08

O N N O O x HCl

(A)

100 mg

236

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Code Product Price Unit

Trimethoprim
MM 0093.00 Trimethoprim
O O O N N NH2 NH2

(A)

500 mg

MM 0093.06

Imp. A (EP): N 2-Methyl-5-(3,4,5-trimethoxybenzyl) pyrimidine-2,4-diamine

O O O N N NH2 NH

(A)

100 mg

MM 0093.01

Imp. B (EP): (2,4-Diaminopyrimidin-5-yl)(3,4,5-trimethoxyphenyl)methanone

O O O O N N NH2 NH2

(A)

100 mg

MM 0093.08

Imp. C (EP): (RS)-(2,4-Diaminopyrimidin-5-yl) (3,4,5-trimethoxyphenyl)methanol

O O O OH N N NH2 NH2

(A)

100 mg

MM 0093.04

Imp. D (EP): 2-Amino-5-(3,4,5-trimethoxybenzyl) pyrimidin-4-ol

O O O N N OH NH2

(A)

100 mg

MM 0093.03

Imp. E (EP): 4-Amino-5-(3,4,5-trimethoxybenzyl) pyrimidin-2-ol

O O O N N NH2 OH

(A)

100 mg

MM 0093.09

Imp. F (EP): 5-(3-Bromo-4,5-dimethoxybenzyl) pyrimidine-2,4-diamine

O O Br N N NH2 NH2

(A)

100 mg

MM 0093.10

Imp. G (EP): 5-(4-Ethoxy-3,5-dimethoxybenzyl) pyrimidine-2,4-diamine

O O O N N NH2 NH2

(A)

100 mg

MM 0093.11

Imp. H (EP): Methyl 3,4,5-Trimethoxybenzoate


O O

O O O

(A)

100 mg

MM 0093.12

Imp. I (EP): 3-(Phenylamino)-2-(3,4,5-trimethoxybenzyl)prop-2-enenitrile (E/Z-mixture) Imp. J (EP): 3,4,5-Trimethoxybenzoic Acid

O O O

H N N O O O O OH

(A)

100 mg

MM 0093.13

(B)

100 mg

MM 0093.17 MM 0093.02

Imp. K (EP) as Hydrochloride: Aniline Hydrochloride 5-(3,4,5-Trimethoxybenzyl)pyrimidin-2,4-diol


O O O

NH2 x HCl

(B) (B)

100 mg 10 mg

N N OH

OH

MM 0093.05

2-Amino-5-(4-hydroxy-3,5-dimethoxybenzyl) pyrimidin-4-ol

O HO O N N OH NH2

(A)

100 mg

MM 0093.07

N4-Methyl-5-(3,4,5-trimethoxybenzyl)pyrimidine -2,4-diamine

O O O N N NH NH2

(C)

50 mg

Trimipramine Maleate
MM 0240.00 Trimipramine Maleate
N N x O O OH OH

(A)

500 mg

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237

Pharmaceutical impurities
Code Product Price Unit

MM 0240.01

Trimipramine
N N

(A)

100 mg

MM 0240.04

Imp. A (EP): (2RS)-3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine N-oxide (Trimipramine N-Oxide)

(A)
N N O

100 mg

MM 0240.02

Imp. B (EP) as Hydrochloride: (2RS)-3-(10,11Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,2-dimethylpropan-1-amine Hydrochloride (Desmethyltrimipramine Hydrochloride) Imp. C (EP) as Hydrochloride: (2RS)-3-(5HDibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan1-amine Hydrochloride

(A)
N N H x HCl

100 mg

MM 0240.05

(A)
N N x HCl

50 mg

MM 0077.00

Imp. D (EP) as Hydrochloride: Imipramine Hydrochloride

(A)
N N x HCl

500 mg

New MM 0240.07

Imp. E (EP): N-[3-(10,11-Dihydro-5H-dibenzo[b,f]azepin-5-yl)-2-methylpropyl]-N,N',N',2tetramethylpropane-1,3-diamine

(A)
N N N

50 mg

MM 0076.06

Imp. F (EP): 10,11-Dihydro-5H-dibenzo[b,f]azepine (Iminodibenzyl)

(B)
NH

100 mg

Tropicamide
MM 0601.00 Tropicamide
O N OH N

(A)

250 mg

MM 0601.01 MM 0601.03

Imp. A (EP): N-(Pyridin-4-ylmethyl)ethanamine Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid) Imp. D (EP): Phenylacetic Acid [Drug Precursor]

HN N O OH OH

(A) (A)

100 mg 100 mg

MM 0160.03

O OH

(B)

100 mg

Tropisetron Hydrochloride
MM 0763.01 Imp. A (EP): (1R,3r,5S)-8-Methyl-8azabicyclo[3.2.1]oct-3-ol (Tropine)
H H HO H N

(A)

100 mg

MM 0763.02

Imp. B (EP): 1H-Indole-3-carboxylic Acid


HN

O OH

(A)

100 mg

Trospium Chloride
MM 0783.09 Imp. A (EP): Hydroxydiphenylacetic Acid (Benzilic Acid)
O OH OH

(B)

100 mg

238

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Pharmaceutical impurities
Code Product Price Unit

Tryptophan
MM 0172.00 L-Tryptophan
H N NH 2 OH O

(A)

500 mg

MM 0172.09

Imp. A (EP): 3,3'-[Ethylidenebis(1H-indole1,3-diyl)]bis[(2S)-2-aminopropanoic] Acid (1,1'-Ethylidenebistryptophan)


HO O NH2

(D)
N N NH2 OH O
H N NH2 OH HO O

100 mg

MM 0172.03

Imp. D (EP): (S)-2-Amino-3-(5-hydroxy-1H-indol-3-yl) propanoic Acid (5-Hydroxytryptophan)

(A)

100 mg

MM 0172.13

N-Acetyltryptophan

H N

O HN OH O

(A)

100 mg

Tyrosine
MM 0634.00 Tyrosine
HO NH2 OH O

(A)

100 mg

Valaciclovir Hydrochloride, Anhydrous


MM 0061.02 Imp. A (EP): 2-Amino-1,9-dihydro-6H-purin-6-one (Guanine) Imp. B (EP): 2-Amino-9-[(2-hydroxy-ethoxy)methyl]1,9-dihydro-6H-purin-6-one (Aciclovir)
H2N O HN N N N O OH
O HN H2N N N N H

(B)

100 mg

MM 0061.00

(A)

500 mg

MM 0619.07

Imp. G (EP): N,N-Dimethylpyridin-4-amine

N N

(A)

100 mg

MM 0061.01

Imp. I (EP): 2-[(2-Amino-6-oxo-1,6-dihydro9H-purin-9-yl)methoxy]ethyl Acetate


H2N

O HN N N N O O O

(A)

100 mg

Valproic Acid
MM 0751.00 Valproic Acid
O OH

(A)

500 mg

MM 0751.11

Sodium Valproate

O ONa

(A)

500 mg

MM 0751.01 MM 0751.02

Imp. A (EP): Pentanoic Acid (Valeric Acid) Imp. B (EP): (2RS)-2-Ethylpentanoic Acid

O OH
O OH

(C) (A)

100 mg 100 mg

MM 0751.03

Imp. C (EP): (2RS)-2-(1-Methylethyl)pentanoic Acid

O OH

(A)

100 mg

MM 0751.04

Imp. D (EP): 2,2-Dipropylpentanoic Acid

O OH

(A)

100 mg

MM 0751.05

Imp. E (EP): Pentanamide (Valeramide)

O NH2

(A)

100 mg

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239

Pharmaceutical impurities
Code Product Price
O NH2

Unit

MM 0751.06

Imp. F (EP): 2-Propylpentanamide

(A)

100 mg

MM 0751.07

Imp. G (EP): 2,2-Dipropylpentanamide

O NH2

(A)

100 mg

MM 0751.08 MM 0751.09 MM 0751.10

Imp. H (EP): Pentanenitrile (Valeronitrile) Imp. I (EP): 2-Propylpentanenitrile Imp. J (EP): 2,2-Dipropylpentanenitrile

N
N

(C) (A) (A)

100 mg 100 mg 100 mg

Valsartan
New MM 0487.04 Imp. C (EP): (2S)-2-[Butanoyl[[2'-(1H-tetrazol-5yl)biphenyl-4-yl]methyl]amino]-3-methylbutanoic Acid
O OH N O N N HN N

(A)

50 mg

Vancomycin Hydrochloride
MM 0239.00 Vancomycin Hydrochloride
NH 2 HO OH O HO OH HO O Cl O HO O NH O N H OH OH OH OH HN O Cl O O O NH O O NH 2 x HCl HN H N O O NH

(A)

100 mg

Venlafaxine Hydrochloride
MM 0393.00 Venlafaxine Hydrochloride
OH N O x HCl

(D)

100 mg

MM 0393.02

Imp. A (EP) as Hydrochloride: 2-(4Methoxyphenyl)-N,N-dimethylethanamine Hydrochloride Imp. B (EP) as Hydrochloride: Ethyl (2RS)-3(Dimethylamino)-2-(4-methoxyphenyl)propanoate Hydrochloride

N O

(A)
x HCl

100 mg

MM 0393.07

(A)
O O N O x HCl

100 mg

MM 0393.08

Imp. C (EP) as Hydrochloride: 1-[(1RS)-2-Amino1-(4-methoxyphenyl)ethyl]cyclohexanol Hydrochloride


O

OH NH2 x HCl

(A)

100 mg

MM 0393.04

Imp. D (EP) as Hydrochloride: 1-[(1RS)-1-(4Methoxyphenyl)-2-(methylamino)ethyl]cyclohexanol Hydrochloride


O

OH H N x HCl

(A)

100 mg

MM 0393.09

Imp. E (EP) as Hydrochloride: (5RS)-5-(4Methoxyphenyl)-3-methyl-1-oxa-3-azaspiro[5.5]undecane Hydrochloride


O

O N x HCl

(A)

100 mg

240

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Pharmaceutical impurities
Code Product Price Unit

MM 0393.10

Imp. F (EP) as Hydrochloride: (2RS)-2(Cyclohex-1-enyl)-2-(4-methoxyphenyl)N,N-dimethylethanamine Hydrochloride


O

(A)
N x HCl

100 mg

MM 0393.03

Imp. G (EP) as Hydrochloride: (2RS)-2Cyclohexyl-2-(4-methoxyphenyl)-N,Ndimethylethanamine Hydrochloride


O

(A)
N x HCl

100 mg

MM 0393.11

Imp. H (EP): 1-[(1RS)-1-(4-Methoxyphenyl)2-[[2-(4-methoxyphenyl)ethyl]amino]ethyl]Cyclohexanol


O

OH H N O

(A)

50 mg

MM 0393.01

O-Desmethylvenlafaxine

OH N HO

(A)

100 mg

Verapamil Hydrochloride
MM 0022.00 Verapamil Hydrochloride
O O N x HCl N O O

(A)

500 mg

MM 0022.07

Imp. A (EP) as Dihydrochloride: N,N'Bis[2-(3,4-dimethoxyphenyl)ethyl]N,N'-dimethylpropane-1,3-diamine Dihydrochloride

O O N

x 2 HCl

O N O

(A)

100 mg

MM 0022.08

Imp. B (EP) as Hydrochloride: 2(3,4-Dimethoxyphenyl)-N-methylethanamine Hydrochloride Imp. C (EP) as Hydrochloride: 2-(3,4Dimethoxyphenyl)-N,N-dimethylethanamine Hydrochloride Imp. D (EP): 3-Chloro-N-[2(3,4-dimethoxyphenyl)ethyl]-N-methylpropan-1-amine Imp. E (EP): (3,4-Dimethoxyphenyl)methanol Imp. F (EP) as Hydrochloride: (2RS)2-(3,4-Dimethoxyphenyl)-5-(methylamino)2-(1-methylethyl)pentanenitrile Hydrochloride
O O
O O

O O NH x HCl

(A)

100 mg

MM 0022.09

(A)
N x HCl

100 mg

MM 0022.02

(A)
N
O O OH

100 mg

Cl

MM 0022.05 MM 0022.10

(B) (A)
O x HCl

100 mg 100 mg

HN N

MM 0022.04

Imp. G (EP): 3,4-Dimethoxybenzaldehyde

O O

(B)

100 mg

MM 0022.11

Imp. H (EP) as Hydrochloride: (2RS)2-(3,4-Dimethoxyphenyl)5-[[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino]2-ethylpentanenitrile Hydrochloride Imp. I (EP) as Hydrochloride: (2RS)2-(3,4-Dimethoxyphenyl)-2-[2-[[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino]ethyl]-3-methylbutanenitrile Hydrochloride

O O O x HCl O

(A)

100 mg

N N

MM 0022.12

O O x HCl N

N O O

(A)

50 mg

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Pharmaceutical impurities
Code Product Price
O x OH OH O O O N H N O O

Unit

MM 0022.21

Imp. J (EP) as Maleate: (2RS)2-(3,4-Dimethoxyphenyl)5-[[2-(3,4-dimethoxyphenyl)ethyl]amino]2-(1-methylethyl)pentanenitrile Maleate (N-Norverapamil Maleate)

(A)

100 mg

MM 0022.03

Imp. K (EP): (2RS)-2-(3,4-Dimethoxyphenyl)3-methylbutylnitrile

O O

(A)

100 mg

MM 0022.13

Imp. L (EP): 1-(3,4-Dimethoxyphenyl)-2methylpropan-1-one


O

O O

(A)

100 mg

MM 0022.15

Imp. N (EP) as Hydrochloride: 5,5'(Methylimino)bis[2-(3,4-dimethoxyphenyl)-2-(1-methylethyl)pentanenitrile] Hydrochloride Imp. O (EP) as Hydrochloride: (2RS)2-(3,4-Dimethoxyphenyl)5-[2-[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino]2-propylpentanenitrile Hydrochloride Diisopropylhomoveratylcyanide

O O x HCl

O O

(A)

50 mg

N N N

MM 0022.16

O O O x HCl O

(A)

100 mg

N N

MM 0022.06

O O N

(D)

100 mg

MM 0022.18

3,4-Dimethoxyphenylacetonitrile

O O

(A)

100 mg

MM 0022.19

Verapamil N-Oxide Hydrochloride


O O O N x HCl N

O O

(C)

50 mg

Vincamine
MM 0519.00 Vincamine
N HO O O H

(A)
N

100 mg

Vinpocetine
MM 0406.00 Vinpocetine
O N H N O

(D)

100 mg

MM 0406.02

Imp. A (EP): Ethyl (12RS,13aSR,13bSR)-13aEthyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (Ethyl Vincaminate)

O O HO N H N

(D)

100 mg

and enantiomer

MM 0406.01

Imp. B (EP): Methyl (13aS,13bS)-13a-Ethyl2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1de]pyrido[3,2,1-ij][1,5]naphthyridine-12carboxylate (Apovincamine)

O O N H N

(D)

100 mg

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Pharmaceutical impurities
Code Product Price Unit

Voriconazole
MM 1094.04 Imp. A (EP): 1-(2,4-Difluorophenyl)-2(1H-1,2,4-triazol-1-yl)ethanone
F O N N N F

(A)

100 mg

Warfarin
New MM 0638.00 Warfarin
O O

(A)

100 mg

OH O

Warfarin Sodium
MM 0732.01 Imp. A (EP): (5RS)-3-(2-Hydroxyphenyl)-5-phenylcyclohex2-enone
OH

(A)

100 mg

MM 0732.02

Imp. B (EP): 4-Hydroxy-2H-1-benzopyran2-one (4-Hydroxycoumarin) Imp. C (EP): (3E)-4-Phenylbut-3-en-2-one (Benzalacetone)


O

(A)

100 mg

OH

MM 0732.03

(A)

100 mg

Xylazine Hydrochloride
MM 0515.00 Xylazine Hydrochloride
S N H N x HCl

(A)

500 mg

MM 0102.02

Imp. A (EP): 2,6-Dimethylaniline (2,6-Xylidine)

H2N

(B)

100 mg

Xylometazoline Hydrochloride
MM 0089.00 Xylometazoline Hydrochloride
N N H x HCl

(A)

500 mg

MM 0089.07

Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)-2[4-(1,1-dimethylethyl)-2,6-dimethylphenyl]acetamide Hydrochloride Imp. B (EP): 2-(Chloromethyl)-5-(1,1-dimethylethyl)1,3-dimethylbenzene Imp. C (EP): [4-(1,1-Dimethylethyl)-2,6dimethylphenyl]acetonitrile Imp. D (EP): 1-(1,1-Dimethylethyl)-3,5dimethylbenzene Imp. F (EP): [4-(1,1-Dimethylethyl)-2,6dimethylphenyl]acetic Acid

(A)
O N H NH2 x HCl

100 mg

MM 0089.04

(A)
Cl

100 mg

MM 0089.03

(A)
N

100 mg

MM 0089.05

(C)

100 mg

MM 0089.02

(A)
O OH

100 mg

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243

Pharmaceutical impurities
Code Product Price Unit

Zaleplon
New MM 1322.00 Zaleplon
N O N N N N

(A)

100 mg

MM 1322.02

N-[3-[3-(Dimethylamino)-1-oxo-2-propenyl]phenyl]N-ethylacetamide
O

(A)
N

100 mg

O N

Zidovudine
MM 0534.00 Imp. A (EP): 1-[(2R,5S)-5-(Hydroxymethyl)-2,5dihydrofuran-2-yl)-5-methylpyrimidine-2,4(1H,3H)-dione (Stavudine) Imp. B (EP): 1-(3-Chloro-2,3-dideoxy--Derythro-pentofuranosyl)-5-methylpyrimidine2,4(1H,3H)-dione
O HN HO O O N

(A)

100 mg

MM 0173.02

O HN HO O O N

(A)

100 mg

Cl

MM 0534.01

Imp. C (EP): 5-Methylpyrimidine-2,4(1H,3H)dione (Thymine)

O HN O N H

(A)

100 mg

MM 0173.04

Imp. D (EP): Triphenylmethanol


OH

(A)

100 mg

MM 0534.03

Thymidine
HN HO O O

(A)

100 mg

OH

Zileuton
New MM 1297.01 N-(1-Benzo-[b]thien-2-ylethyl)urea
S NH2 HN O

(A)

50 mg

MM 1297.02

2-(Benzo[b]thien-2-oyl)benzo[b]thiophene
S

(A)
S
O S

50 mg

MM 1297.03

1-Benzo-[b]thien-2-ylethanone

(A)

100 mg

Ziprasidone Hydrochloride Monohydrate


MM 1273.00 Ziprasidone Hydrochloride Monohydrate
O HN x HCl x H2O

(A)

100 mg

N Cl N N S

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Code Product Price Unit

Zolpidem Tartrate
New MM 0333.11 Zolpidem Tartrate [Controlled Substance]
N O N N 2 OH x HO O OH O OH

(A)

100 mg

MM 0333.01

Imp. A (EP): N,N-Dimethyl-2-[7-methyl2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl] acetamide

(D)
N O N N

100 mg

MM 0333.02

2-[6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridin-3-yl] acetamide

(A)
N O N NH2

100 mg

MM 0333.03

2-[6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridin-3-yl] acetic Acid

(A)
N O N OH

100 mg

MM 0333.04

Methyl 2-[6-Methyl-2-(4-methylphenyl)imidazo[1,2-a] pyridin-3-yl]acetate

(D)
N O N O

50 mg

MM 0333.05

6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridine3-acetonitrile

(A)
N N N

100 mg

MM 0333.06

Oxozolpidem (N,N,6-Trimethyl-2-(4-methylphenyl)-oxo-imidazo [1,2-a]pyridine-3-acetamide)

(D)
N O N O N

100 mg

MM 0333.07

Zolpaldehyde (6-Methyl-2-(4-methylphenyl)-imidazo[1,2-a] pyridine-3-carboxaldehyde)

(A)
N N O

100 mg

MM 0333.08

Zolpyridine (4-Methyl-N-(5-methyl-2-pyridinyl)-benzamide)
N

H N O

(A)

100 mg

MM 0333.09

6-Methyl-2-(4-methylphenyl)--oxo-imidazo[1,2a]pyridine-3-acetamide

(A)
N O N O NH2

100 mg

MM 0333.10

Methyl -Hydroxy-6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetate

(A)
N O N HO O

100 mg

Zonisamide
New MM 1379.00 Zonisamide
O O S NH2 N O

(A)

100 mg

Zopiclone
MM 0149.00 Zopiclone
N N N N O O N O N Cl

(D)

100 mg

Edition 2012/2013

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245

Pharmaceutical impurities
Code Product Price
O N O N N N O N O N Cl

Unit

MM 0149.01

Imp. A (EP): (5RS)-6-(5-Chloropyridin-2-yl)-7-oxo6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4Methylpiperazine-1-carboxylate 4-Oxide (Zopiclone Oxide) Imp. B (EP): (7RS)-6-(5-Chloropyridin-2-yl)-7hydroxy-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-one

(D)

100 mg

MM 0149.02

HO N N N O N

Cl

(D)

100 mg

MM 0149.03

Imp. C (EP): 6-(5-Chloropyridin-2-yl)-6,7dihydro-5H-pyrrolo[3,4-b]pyrazin-5-one


N N

Cl N O
Cl H2N N

(A)

50 mg

MM 0149.04 MM 0149.05

2-Amino-5-chloropyridine 3-(5-Chloropyridine-2-carbamoyl)-2-pyrazinecarboxylic Acid


N N O

(A) (A)

250 mg 100 mg

O N H OH N

Cl

MM 0149.06

6-(5-Chloropyridin-2-yl)- 6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5,7-dione


N N

O N O
O N N N H N

Cl N

(A)

100 mg

MM 0149.07

5-(Chloropyridine-2-yl-carbamoyl)pyrazine

Cl

(A)

100 mg

MM 0149.50

2-Acetylamino-5-chloropyridine

O N H N

Cl

(A)

100 mg

246

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Edition 2012/2013

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European Pharmacopoeia

European Pharmacopoeia
Background
The European Pharmacopoeia (EP) Commission includes in its membership delegates from nations who have adopted the European Pharmacopoeia. The EP Commission is in charge of judging the suitability of monographs. Prior to release, a new monograph must be adopted by the EP Commission, and then published in the annual Fascicule. Member States then officially adopt the new monograph on 1st January of the following year. To support the monographs of the European Pharmacopoeia, a collection of reference substances has been made available which includes: 1. 2. 3. Current, official, European Pharmacopoeia Chemical Reference Substances (EP CRS) and Biological Reference Preparations (BRP) Reference Spectra Other reference preparations, including Enzymes and Substrates from the International Commission on Pharmaceutical Enzymes and Certified Viscosity Standards from Van Swinden Laboratories. With supplement 4.3, the revised EP general method 2.2.6 replaces CRS reference liquids with certified reference materials available from suppliers of chemical reagents or materials certified for metrology. Ten liquid CRMs, certified by the Physical Chemistry Division of the Central Office of Measures (GUM), Warsaw in Poland, cover the wide range of refractive index from 1,333 (water) to 1,657 (1-bromonaphthalene). More detailed information is given in the chapter "Dyes and refractive index CRMs" of this catalogue. European Pharmacopoeia Reagents.

4.

5.

Relationship with other pharmacopoeias in Europe


Any reference substance, spectra or preparation required for a new EP monograph, is made available as soon as the monograph comes into force. Many of the member countries of the European Pharmacopoeia Commission have adopted the EP in full, and their monographs require only EP CRS/BRP. When an EP monograph is adopted by the pharmacopoeia of a member state of the Council of Europe then any reference material that may have been available from a national pharmacopoeia, e.g. BP or PF, will usually be discontinued in favour of the EP reference substance. However, a number of member countries of the EP Commission maintain national pharmacopoeial monographs, especially for finished dosage forms, which require the use of separate reference substances. A separate chapter in this catalogue includes lists of the reference substances produced for the British, French, Swiss and International pharmacopoeia monographs. The International Pharmacopoeia (IP) reference substances are described in the section referring to the WHO (World Health Organization).

Production and certification


European Pharmacopoeia reference substances and preparations are selected and verified by the EP laboratories as being suitable for the use as prescribed in the relevant monograph of the European Pharmacopoeia. Since CRS and BRP are officially certified by the European Pharmacopoeia Commission, it should be noted that neither certificates of analysis nor data not relevant to the use of the products as defined by the EP monograph are provided with the reference product or substance.

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249

European Pharmacopoeia Storage, shelf life and expiry dates and size units
European Pharmacopoeia CRS/BRP are subject to regular inspection and repeated analysis by EP scientific staff. Each EP CRS/BRP is, on receipt by the customer, fit for the intended use. No expiry date is indicated on the reference materials because the products or substances comply with the requirements of the corresponding monograph and are monitored regularly. When batches are to be changed, LGC Standards can provide you with the date on which the previous lot will no longer be official. In specific cases for reasons related to filling or labeling, sub-batches are obtained from the same batch of bulk material. However, all the necessary precautions are taken in order to guarantee that the quality and specifications of the sub-batches do not differ from one to another. Please note, that new lots can have different unit sizes, especially with pharmacopoeial reference standards, and LGC Standards is not responsible for such cases. If the unit size of a new batch changes, LGC Standards will provide this information to customers in new lot lists. The EP is also currently over-labelling all its reference standards vials with a secondary label. This new secondary label is useful for customs purposes as it can be peeled off. It can also be stuck onto your laboratory book to prove the use of the reference standard. All the required information to perform the tests described in the European Pharmacopoeia monographs are stated on the primary label. EP recommends only sufficient material should be purchased for immediate use and that unopened vials should be stored in the dark unless otherwise stated. Whilst most EP CRS/BRP can be shipped at ambient temperature, certain items have to be maintained at controlled temperatures at all times and are subject to special shipping charges and storage conditions (details are available on request). Where no drying conditions are stated, the substance is to be used as received. Once opened, EP can no longer guarantee the stability of the material and any of the CRS/BRP not used should be disposed of and not kept for future use.

Validation of secondary standards


All secondary in-house working standards have to be validated against the corresponding EP CRS/BRP. Please make sure that the secondary material is used only for the same official purposes for which the primary pharmacopoeial material was designed.

Proper use
EP discontinued their use code number system as of January 2006. For information on the use of the substances please refer to the monograph or contact your local LGC Standards office.

Opening
For reference substances and preparations supplied in sealed glass ampoules the following technique is suitable for opening the ampoule: tap gently to collect the material at the lower end, score the ampoule with a file, heat a glass rod to white heat and apply firmly to the file mark. If the glass does not crack, deepen and extend the file mark, and repeat the process. Eye and hand protection MUST be used. Many reference substances are supplied as lyophilised material in a septum vial. No attempt should be made to open the vial and weigh out the powder. It is important to strictly follow the monograph instructions, reconstitute the material in a buffer solvent and handle the resultant solution volumetrically.

Toxicity
The potential toxicity of certain reference substances is such that special precautions should be taken to avoid contact. Such substances should be manipulated in a glove box. If this is not possible, gloves, eye protection and a mask should be worn. Following the guidelines suggested by the EP does not replace the need to carry out a full hazard assessment. Biological and blood products should be regarded as potentially hazardous to health and therefore used and disposed of according to established laboratory safety procedures.

Controlled Substances
The EPs product range contains substances subject to Controlled Substance regulations schedules. Special ordering procedures apply, so please contact LGC Standards for details and costs.

250

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Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000055 EPY0000116 EPY0000500 EPY0000354 EPY0000427 EPA0040000 EPY0000359

Acamprosate calcium - Reference Spectrum Acamprosate impurity A 3-aminopropane-1-sulphonic acid Acarbose Acarbose for identification Acarbose for peak identification Acebutolol hydrochloride Acebutolol impurity B N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl]acetamide (diacetolol) Acebutolol impurity C N-(3-acetyl-4-hydroxyphenyl)butanamide Acebutolol impurity I N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl)butanamide Aceclofenac - Reference Spectrum Aceclofenac for peak identification Aceclofenac impurity F benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate Aceclofenac impurity H [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic acid Acemetacin Acemetacin impurity A 4-chlorobenzoic acid Acemetacine impurity mixture Acesulfame potassium Acesulfame potassium impurity B 5-chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide Acetazolamide Acetazolamide for system suitability Acetylcholine chloride Acetylcysteine Acetylcysteine impurity C N,N'-diacetyl-L-cystine Acetylcysteine impurity D N,S-diacetyl-L-cysteine -Acetyldigoxin -Acetyldigoxin for peak identification Acetylsalicylic acid Acetylsulfadiazine N-Acetyltryptophan N-Acetyltyrosine Acholeplasma laidlawii BRP Aciclovir Aciclovir for system suitability Aciclovir for peak identification 1 Aciclovir for peak identification 2 Actaea racemosa HRS Actaea racemosa for assay CRS Acitretin Actaea rasemosa dry extract for system suitability HRS Adapalene Adapalene impurity C 1-[2-(methyloxy)phenyl]tricyclo[3.3.1.1]decane Adapalene for peak identification Adenine

unit 50 mg 94.7 mg 10 mg 40 mg 50 mg 10 mg

EPY0000127 EPY0000128 EPY0000056 EPY0001094 EPY0000085 EPY0000086 EPY0000810 EPY0000811 EPY0000842 EPA0070000 EPA0070020 EPA0100000 EPY0001084 EPY0000002 EPA0150000 EPA0152000 EPA0153000 EPY0000565 EPY0000642 EPA0200000 New EPY0001462 EPA0208000 EPA0202000 EPY0000693 EPA0220000 EPY0001264 EPY0001271 EPY0001269 New EPY0001463 New EPY0001543 EPA0225000 New EPY0001464 EPY0001121 EPY0001120 EPY0001119 EPA0230000

20 mg 0.004 mg unit 10 mg 20 mg 10 mg 100 mg 10 mg 0.06 mg 50 mg 50 mg 100 mg 0.0068 mg 50 mg 50 mg 10 mg 10 mg 50 mg 10 mg 15 mg 0.002 mg 125 mg 200 mg 1 mL 75 mg 10 mg 0.3 mg 0.004 mg 1200 mg 300 mg 100 mg 1200 mg 100 mg 6 mg 2.022 mg 50 mg

Edition 2012/2013

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251

European Pharmacopoeia
Code Product Unit

EPA0230200 EPY0000110 EPY0000882 EPY0000883 EPA0300000 EPY0000740 EPY0000707 EPY0000728 EPA0325000 EPA0325100 EPA0325200 EPA0325450 EPA0325451 EPA1225000 EPA0325500 EPA0325800 EPY0000832 EPA0349000 EPA0350000 EPA0350010 EPA0350020 EPA0350030 EPA0350040 EPA0350050 EPA0351000 EPY0000235 EPY0000255 EPA0357000 EPA0360000 EPY0000054 EPY0000606 EPY0000843 EPY0000687 EPY0000595 EPY0000607 EPA0363000 EPA0363700 EPA0900000 EPA0365000 EPA0368000 New EPY0001467 EPA0365900 EPY0001117 EPA0370000 EPY0000020

Adenosine Adipic acid Adrenaline Adrenaline with impurity F Adrenaline tartrate Adrenaline impurity mixture Adrenaline tartrate with impurity A Agnus castus fruit standardised dry extract Alanine Albendazole Alcuronium chloride Alfacalcidol Alfacalcidol - Reference Spectrum Alfadex Alfentanil hydrochloride - Reference Spectrum Alfuzosin hydrochloride Alfuzosin for system suitability Allantoin Allopurinol Allopurinol impurity A 5-amino-1H-pyrazole-4-carboxamide Allopurinol impurity B 5-formylamino-1H-pyrazole-4-carboxamide Allopurinol impurity C 5-(4H-1,2,4-triazol-4-yl)1H-pyrazole-4-carboxamide Allopurinol impurity D ethyl 5-amino-1H-pyrazole-4-carboxylate Allopurinol impurity E ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate Allylstrychnine bromide Almagate Almagate - Reference Spectrum Alprazolam Controlled Substance Alprenolol hydrochloride Alprostadil Altizide Altizide impurity B 3-[(2,2-dimethoxyethyl)sulphanyl]prop-1-ene Alverine citrate Alverine for peak identification Alverine impurity D N-(3-cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine Amantadine hydrochloride Ambroxol hydrochloride Amfetamine sulfate - Reference Spectrum Amidotrizoic acid dihydrate Amikacin Amikacin impurity I (2S)-4-amino-2-hydroxybutanoic acid Amikacin sulfate Amikacin for system suitability Amiloride hydrochloride Amiloride impurity A methyl-3,5-diamino-6-chloropyrazine-2-carboxylate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

50 mg 50 mg 5 mg 10 mg 100 mg 0.005 mg 15 mg 200 mg 60 mg 50 mg 50 mg 5 mg unit 150 mg unit 10 mg 10 mg 60 mg 100 mg 10 mg 10 mg 10 mg 10 mg 20 mg 10 mg 25 mg unit 100 mg 100 mg 50 mg 150 mg 15 mg 5 mg 0.125 mg 10 mg 100 mg 125 mg unit 100 mg 200 mg 20 mg 200 mg 10 mg 100 mg 10 mg

252

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000173 EPA0420000 EPA0460000 EPA0496000 EPA0496005

4-Aminobenzoic acid Aminocaproic acid 7-Aminodesacetoxycephalosporanic acid Aminoglutethimide Aminoglutethimide impurity A (3RS)-3-(3-aminophenyl)-3-ethylpiperidine-2,6-dione; (3-aminoglutethimide) Aminoglutethimide impurity D 3,3'-[diazenediyldi(4,1-phenylene)]bis(3-ethylpiperidine-2,6-dione) (azoglutethimide) Amiodarone hydrochloride Amiodarone impurity D (2-butyl-benzofuran-3-yl)-(4-hydroxy-3,5-diiodophenyl)methanone Amiodarone impurity E (2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone Amisulpride Amisulpride impurity B 4-amino-N-[[(2RS )-1-ethylpyrrolidin-2-yl] methyl]-5-(ethyl sulphonyl)-2-hydroxybenzamide Amitriptyline hydrochloride Amlodipine besilate Amlodipine for peak identification Amlodipine impurity A 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2yl)ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Amlodipine impurity B 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2(methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate Amlodipine impurity G dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate Ammonio methacrylate copolymer (type A) - Reference Spectrum Ammonio methacrylate copolymer (type B) - Reference Spectrum Amobarbital Controlled Substance Amobarbital sodium Controlled Substance Amoxicillin trihydrate Amphotericin B Amphotericin B for microbiological assay Amphotericin B for peak identification Ampicillin (anhydrous) Ampicillin trihydrate Amylmetacresol Amylmetacresol for peak identification Angelica dahuria root Anhydrotetracycline hydrochloride Antazoline hydrochloride Apomorphine hydrochloride - Reference Spectrum Apomorphine hydrochloride hemihydrate Apomorphine impurity B (Morphine sulfate) (Morphinhemisulfat-Pentahemihydrat) Controlled Substance Alpha-apo-oxytetracycline Beta-apo-oxytetracycline Aprotinin solution BRP Aprotinin for system suitability L-Arabinitol Arbutin Arginine Arginine aspartate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

60 mg 50 mg 20 mg 125 mg 20 mg

EPA0496020 EPA0575000 EPY0000129 EPY0000130 EPA0590000 EPA0590004 EPY0000563 EPY0000049 EPY0001067 EPY0001068

10 mg 100 mg 20 mg 20 mg 10 mg 10 mg 10 mg 150 mg 10 mg 10 mg

EPY0001069

10 mg

EPY0001070 EPY0000302 EPY0000303 EPA0650000 EPA0700000 EPA0800000 EPY0000005 EPY0001361 EPY0001014 EPA1000000 EPA1100000 EPY0001244 EPY0001245 EPY0001386 EPA1200000 EPA1210000 EPY0000172 EPY0001465 New EPY0001471 EPA1220000 EPA1230000 EPA1250000 EPY0001154 EPA1269000 EPY0000806 EPA1270000 EPY0000304
Edition 2012/2013

10 mg unit unit 500 mg 500 mg 100 mg 100 mg 100 mg 10 mg 250 mg 150 mg 285 mg 10 mg 160 mg 15 mg 50 mg unit 15 mg 40 mg 20 mg 20 mg 0.5 mL 2.7 mg 10 mg 100 mg 50 mg 20 mg
253

European Pharmacopoeia
Code Product Unit

EPA1271000 New EPY0001323 EPY0001185 EPY0001175 EPY0000079 EPY0000080 EPY0000081

Arginine hydrochloride Aristolochia Aristolochic acid I Aristolochic acid for system suitability Articaine hydrochloride Articaine impurity A methyl3-[[2-(propylamino)acetyl]amino]-4-methylthiophene-2-carboxylate Articaine impurity E methyl 4-methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl] amino]thiophene-2-carboxylate Ascorbic acid (Vitamin C) Ascorbic acid impurity C D-sorbosonic acid Ascorbic acid impurity D methyl D-xylo-hex-2-ulosonate (methyl D-sorbosonate) Ascorbyl palmitate Asparagine monohydrate Aspartame Aspartame impurity A 2-(5-benzyl-3,6-dioxopiperazin-2-yl)acetic acid (diketopiperazine) Aspartic acid Astragaloside IV Atenolol Atenolol for system suitability Atorvastatine calcium trihydrate Atorvastatin impurity A desfluoroatorvastatin Atorvastatin impurity B 3-epi-atorvastatin Atorvastatin impurity C fluoroatorvastatin Atorvastatin impurity D 3-[(4-fluorophenyl)carbonyl]-2-(2-methylpropanoyl)-N,3-diphenyloxirane-2-carboxamide Atorvastatin impurity E ent-atorvastatin Atracurium besilate Atracurium for impurity F identification Atracurium for peak identification Atropine Atropine for peak identification Atropine impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl (2RS)-3-hydroxy-2-phenylpropanoate (noratropine) Atropine sulphate Azaperone Azathioprine Azathioprine impurity A 1-methyl-4-nitro-1H-imidazol-5-amine Azathioprine impurity G 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7H-purin-2-amine (thiamiprine) Azelastine hydrochloride Azelastine impurity B 1-benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane Azelastine impurity D 4-(4-chlorobenzyl)phthalazin-1(2H)-one Azelastine impurity E 3-(4-chlorobenzilidene)isobenzofuran-1(3H)-one

50 mg 140 mg 1 mg 1 mg 100 mg 15 mg 10 mg

EPA1300000 EPY0001024 EPY0001170 EPY0000800 EPY0000305 EPA1320000 EPA1321000 EPA1330000 EPY0001171 EPA1340000 EPY0001089 EPY0001327 EPY0001328 EPY0001329 EPY0001330 EPY0001331 EPY0001332 EPY0000424 EPY0000503 EPY0000504 EPY0000878 EPY0000845 EPY0000816 EPA1400000 EPY0000029 EPA1500000 EPY0001240 EPY0001246 EPY0000326 EPY0000327 EPY0000328 EPY0000329

100 mg 20 mg 10 mg 10 mg 60 mg 40 mg 10 mg 50 mg 40 mg 100 mg 5 mg 150 mg 10 mg 10 mg 10 mg 10 mg 10 mg 120 mg 5 mg 5 mg 30 mg 0.25 mg 10 mg 50 mg 50 mg 100 mg 10 mg 5 mg 25 mg 5 mg 5 mg 5 mg

254

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Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000306 EPY0000637 EPY0000641 EPY0000307 EPY0000285 EPB0070000 EPB0100000 EPB0200000 EPB0200050 EPY0001273 EPB0250000 EPB0300000 EPY0000295 EPB0305000 EPY0000351 EPY0000352 EPY0000469 EPY0001073 EPY0001025 EPY0001038 EPY0001026

Azithromycin Azithromycin for peak identification Azithromycin for system suitability Azithromycin impurity A 6-demethylazithromycin B19 virus DNA for NAT testing BRP Bacampicillin hydrochloride Bacitracin zinc Baclofen Baclofen impurity A (RS)-4-amino-3-(4-chlorophenyl)butyric acid lactam Baicalin Bambuterol hydrochloride Barbital Controlled Substance Basic butylated methacrylate copolymer - Reference Spectrum Beclometasone dipropionate anhydrous Beclometasone dipropionate monohydrate Beclometasone dipropionate for system suitability Beclometasone dipropionate for peak identification Beclometasone dipropionate impurities F and N Benazepril hydrochloride Benazepril for system suitability Benazepril impurity A [(3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-2,3,4,5-tetrahydro-1H-1benzazepin-1-yl]acetic acid Bendroflumethiazide Bendroflumethiazide impurity A 4-amino-6-(trifluoromethyl)benzene-1,3-disulphonamide Benfluorex hydrochloride Benfluorex hydrochloride for system suitability Benperidol Benserazide hydrochloride Benserazide impurity A (RS)-2-amino-3-hydroxypropanohydrazide Benserazide impurity C (2RS)-2-amino-3-hydroxy-2'-[(1EZ)-(2,3,4-trihydroxybenzylidene)]propanohydrazide Benserazide for peak identification Benzaldehyde Benzalkonium chloride for system suitability Benzarone (2-ethylbenzofuran-3-yl)(4-hydroxyphenyl)methanone Benzathine benzylpenicillin Benzbromarone Benzethonium chloride Benzocaine Benzoic acid Benzophenone Benzyl alcohol Benzyl benzoate - Reference Spectrum S-Benzylmercaptoacetyltriglycin Benzylpenicillin potassium Benzylpenicillin sodium Berberine chloride

200 mg 15 mg 0.05 mg 10 mg 150 mg 120 mg 150 mg 50 mg 50 mg 10 mg 100 mg 500 mg unit 150 mg 10 mg 10 mg 10 mg 0.052 mg 160 mg 0.016 mg 10 mg

EPB0400000 EPY0000564 EPY0000044 EPY0000043 EPB0470000 EPB0477000 EPB0477010 EPY0001071 EPY0001079 EPY0001064 EPY0001060 EPB0490000 EPB0500000 EPY0000775 EPB0550000 EPB0600000 New EPY0001470 EPY0000647 EPY0000167 EPB0670000 EPB0680000 EPB0700000 EPB0900000 EPY0001149

100 mg 5 mg 50 mg 360 mg 100 mg 50 mg 20 mg 10 mg 10 mg 150 mg 20 mg 10 mg 125 mg 10 mg 100 mg 50 mg 30 mg 40 mg 50 mg unit 10 mg 50 mg 200 mg 20 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

255

European Pharmacopoeia
Code Product Unit

EPB0950000 EPY0000391 EPB0990000 EPB1000000 EPB1030000 EPB1040000 New EPY0001416 New EPY0001418 EPB1045000 EPB1054000 EPB1055000 EPY0001027 EPY0001065 EPY0001360 EPB1103000 EPB1103100 EPY0001354 EPB1115000 New EPY0001444 New EPY0001448 EPY0001078 EPB1110000 New EPY0001421 EPB1110004 EPY0001059 EPB1116000 EPB1120000 EPB1121000

Betadex Betahistine dihydrochloride Betahistine mesilate Betamethasone Betamethasone acetate Betamethasone diproprionate Betamethasone dipropionate for peak identification Betamethasone dipropionate for system suitability Betamethasone sodium phosphate Betamethasone-17-valerate Betamethasone-21-valerate Betamethasone valerate for system suitability Betamethasone valerate impurity mixture Betaxolol for peak identification Betaxolol hydrochloride Betaxolol impurity A (2RS)-1-(4-ethylphenoxy)-3-[(1-methylethyl)-amino]propan-2-ol Betaxolol impurity C 2-[[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane Bezafibrate Bicalutamide Bicalutamide for system suitability Bicisate labelling kit Bifonazole Bifonazole for system suitability Bifonazole impurity B 4-[(RS)-(biphenyl-4-yl)phenylmethyl]-1H-imidazole trifluoroacetate Bilberry dry extract Biotin (Vitamin H) Biperiden hydrochloride Biperiden impurity A (1RS)-1-[(1SR,2SR,4SR)-bicyclo[2.2.1]hept-5-en-2-yl]-1-phenyl-3-(piperidin-1-yl)propan-1-ol (endo form) Bisacodyl Bisacodyl for peak identification Bisacodyl for system suitability Bisoprolol fumarate Bisoprolol for peak identification Bisoprolol for system suitability method A CRS has been renamed as Bisoprolol for peak identification CRS Bisoprolol for system suitability Bisoprolol for system suitability method B CRS has been renamed as Bisoprolol for system suitability CRS Bleomycin sulfate Boldine Bordetella pertussis mouse antiserum BRP Bromazepam Controlled Substance Bromazepam for system suitability Controlled Substance Bromhexine hydrochloride Bromhexine impurity C N-(2-aminobenzyl)-N-methylcyclohexanamine Bromocriptine mesilate Bromocriptine mesilate for system suitability Bromperidol

200 mg 50 mg 100 mg 75 mg 100 mg 150 mg 10 mg 10 mg 100 mg 100 mg 15 mg 25 mg 0.018 mg 15 mg 60 mg 10 mg 5 mg 100 mg 100 mg 15 mg 24 mg 100 mg 10 mg 10 mg 250 mg 20 mg 60 mg 20 mg

EPB1140000 EPY0000608 EPY0000694 EPY0000812 EPY0000877

50 mg 10 mg 5 mg 50 mg 1 mg

EPY0000813

1 mg

EPB1141000 EPY0000434 EPB1142000 EPB1143000 EPY0000645 EPB1145000 EPY0000200 EPB1150000 EPY0000677 EPB1152000

7 mg 30 mg 0.5 mg 60 mg 10 mg 100 mg 10 mg 30 mg 5 mg 100 mg

256

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPB1152050 EPB1153000 EPY0000468 EPY0000470

Bromperidol decanoate Brompheniramine maleate Brotizolam Controlled Substance Brotizolam impurity B 2-bromo-4-(2-chlorophenyl)-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine (demethylbrotizolam) Brucella melitensis Rev. 1 strain BRP Budesonide Budesonide for system suitability Bufexamac Buflomedil hydrochloride Buflomedil impurity B 4-(pyrrolidin-1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one Bumetanide Bumetanide impurity A 3-nitro-4-phenoxy-5-sulphamoylbenzoic acid Bumetanide impurity B 3-amino-4-phenoxy-5-sulphamoylbenzoic acid Bupivacaine hydrochloride Bupivacaine impurity B (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Bupivacaine impurity E 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide Buprenorphine Controlled Substance Buprenorphine hydrochloride Controlled Substance Buprenorphine for system suitability Controlled Substance Buserelin D-His-Buserelin Buspirone hydrochloride Buspirone for system suitability Busulfan Butyl methanesulfonate Butyl parahydroxybenzoate Butyl parahydroxybenzoate impurity E 2-methylpropyl 4-hydroxybenzoate (iso-butyl parahydroxybenzoate) Butylhydroxyanisole Butylhydroxytoluene Plastic additive 07 Cabergoline Caffeine Caffeine for system suitability Calcifediol Calcifediol - Reference Spectrum Calcipotriol (anhydrous) - Reference Spectrum Calcipotriol monohydrate Calcipotriol monohydrate - Reference Spectrum Calcitonin (salmon) Calcitonin-Gly N-acetyl-cys1-calcitonin Calcitriol Calcitriol - Reference Spectrum Calcium ascorbate - Reference Spectrum Calcium folinate Calcium glucoheptonate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

60 mg 100 mg 10 mg 10 mg

EPB1155000 EPB1157300 EPY0001148 EPB1156000 EPB1157400 EPB1157410 EPB1158000 EPY0000309 EPY0000310 EPB1160000 EPY0000088 EPY0000089 EPY0001108 EPY0001109 EPY0001122 EPB1168000 EPB1168020 EPY0000131 EPY0000471 EPB1170000 EPY0001304 EPB1217000 EPY0001357 EPB1212000 EPB1215000 EPY0000472 EPC0100000 EPY0000787 EPC0166000 EPC0166001 EPY0000499 EPY0000473 EPY0000474 EPC0200000 EPY0000632 EPC0200010 EPC0225000 EPC0226000 EPC0249000 EPC0250000 EPC0299000
Edition 2012/2013

1 mL 110 mg 10 mg 100 mg 100 mg 20 mg 150 mg 5 mg 5 mg 100 mg 20 mg 20 mg 10 mg 10 mg 10 mg 2 mg 0.5 mg 5 mg 2 mg 50 mg 30 l 100 mg 15 mg 50 mg 50 mg 100 mg 70 mg 20 mg 5 mg unit unit 5 mg unit 2x0.98 mg 0.4 mL 20 mg 10 mg unit unit 100 mg 60 mg
257

European Pharmacopoeia
Code Product Unit

EPC0300000 EPC0340000 EPC0350000 EPC0400000 EPC0405000 EPY0001388 New EPY0001387 EPY0001389 EPC0410000 EPC0426000 EPY0000671 EPC0430000 EPY0001182 EPY0001219 EPY0001220 EPY0001221 EPY0000435 New EPY0001450

Calcium gluconate Calcium levulinate dihydrate Calcium oxalate monohydrate Calcium pantothenate Camphor (racemic) Candesartan cilexetil Candesartan cilexetil for peak identification Candesartan cilexetil for system suitability Canrenone Caprylic acid Capsaicin Captopril Captopril for system suitability Captopril impurity B (2S) 1-[(2S)-3-bromo-2-methylpropanoyl]pyrrolidine-2-carboxylic acid Captopril impurity C (2RS)-2-methyl-3-sulphanylpropanoic acid Captopril impurity D (2RS)-3-bromo-2-methylpropanoic acid Captopril impurity E (2S)-1-isobutyryl-pyrrolidine-2-carboxylic acid Captopril impurity J (2S)-1-[(2S)-3-(acetylsulfanyl)-2-methylpropanoyl]pyrrolidine-2-carboxylic acid (acetylcaptopril) Carbachol Carbamazepine Carbamazepine impurity A 10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide(10,11-dihydrocarbamazepine) Carbasalate calcium - Reference Spectrum Carbasalate impurity B 2-[[2-(acetyloxy)benzoyl]oxy]benzoic acid (acetylsalicylsalicylic acid) Carbenicillin sodium Carbidopa Carbimazole Carbocisteine Carbon dioxide - Reference Spectrum Carboplatin - Reference Spectrum Carboprost trometamol Carboprost trometamol - Reference Spectrum Carisoprodol Carisoprodol impurity A (2RS)-2-(hydroxymethyl)-2-methylpentyl(1-methylethyl)carbamate Carmellose Carmustine - Reference Spectrum Carmustine impurity A 1,3-bis(2-chloroethyl)urea Carprofen for veterinary use Carprofen for system suitability Carteolol hydrochloride - Reference Spectrum Carteolol for system suitability Carvedilol - Reference Spectrum Carvedilol Carvedilol for system suitability Carvedilol impurity C (2RS)-1-[benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H-carbazol-4-yloxy) propan-2-ol
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg 250 mg 500 mg 60 mg 50 mg 60 mg 10 mg 10 mg 50 mg 200 mg 50 mg 10 mg 20 mg 10 mg 10 mg 10 mg 10 mg 10 mg

EPY0000113 EPC0450000 EPY0000033 EPC0451000 EPY0001161 EPC0455000 EPC0460000 EPC0465000 EPC0470000 EPC0499900 EPC0550000 EPY0000475 EPY0000536 EPY0000035 EPY0000036 EPY0001214 EPC0580004 EPC0580010 EPY0000846 EPY0000884 EPY0000192 EPY0000193 EPY0000075 New EPY0001427 New EPY0001426 EPY0000103

50 mg 200 mg 10 mg unit 5 mg 50 mg 50 mg 100 mg 60 mg unit unit 40 mg unit 50 mg 10 mg 10 mg unit 20 mg 30 mg 5 mg unit 30 mg unit 50 mg 10 mg 10 mg

258

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPC0600000 EPC0630000 EPC0640000 EPC0650000 EPC0675000 EPC0682000 EPY0000505 EPC0682300 EPY0000240 EPC0682400 EPC0682410

Casein BRP Cefaclor Delta-3-Cefaclor Cefadroxil Cefalexin monohydrate Cefalotin sodium Cefalotin for impurity B identification Cefamandole nafate Cefapirin sodium Cefatrizine propylene glycol Cefatrizine impurity A 7-amino-(6R,7R)-3-[(2H-1,2,3-triazol-4-yl)sulfanyl]-methyl-8-oxo-5-thia-1azabicyclo[4.2.O]oct-2-ene-2-carboxylic acid(7-ACA triazole) Cefazolin Cefepime dihydrochloride monohydrate Cefepime dihydrochloride monohydrate for system suitability Cefepime impurity E (6R,7R)-7-amino-3-[(1-methylpyrrolidinio)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct2-ene-2-carboxylate Cefixime Cefoperazone dihydrate Cefoperazone sodium - Reference Spectrum Cefotaxime acid Cefotaxime sodium Cefotaxime for peak identification Cefoxitin sodium Cefpodoxime proxetil Cefpodoxime proxetil for peak identification Cefpodoxime proxetil for impurity H identification Cefprozil Cefprozil impurity A (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid (p-hydroxyphenylglycine) Cefprozil for peak identification Cefprozil impurity mixture Cefradine Cefradine for peak identification Cefradine impurity mixture Ceftazidime Ceftazidime for peak identification Ceftriaxone sodium Ceftriaxone impurity A E-isomer Cefuroxime axetil Cefuroxime sodium Celecoxib Celecoxib impurity A 4-[5-(3-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Celecoxib impurity B 4-[3-(4-methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Celiprolol hydrochloirde Celiprolol impurity I 1-acetyl-1-(4-ethoxyphenyl)-3,3-diethylurea Celiprolol for peak identification Cellulose acetate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 g 450 mg 20 mg 250 mg 150 mg 100 mg 10 mg 125 mg 100 mg 150 mg 60 mg

EPC0682800 EPY0000633 EPY0000634 EPY0001336

150 mg 150 mg 15 mg 10 mg

EPC0684000 EPC0684750 EPC0684800 EPY0000420 EPC0685000 EPY0000506 EPC0688000 EPY0001305 EPY0001306 EPY0001318 New EPY0001371 New EPY0001372 New EPY0001367 New EPY0001368 EPC0690000 EPY0000568 EPY0001174 EPC0690500 EPY0001111 EPC0691000 EPC0692000 EPC0694990 EPC0695000 New EPY0001445 New EPY0001446 New EPY0001447 EPY0000311 EPY0000312 EPY0000239 EPY0000784
Edition 2012/2013

200 mg 100 mg unit 80 mg 30 mg 10 mg 100 mg 70 mg 10 mg 10 mg 120 mg 20 mg 10 mg 10 mg 300 mg 15 mg 0.04 mg 200 mg 10 mg 80 mg 10 mg 60 mg 150 mg 200 mg 10 mg 10 mg 10 mg 0.02 mg 20 mg 40 mg
259

European Pharmacopoeia
Code Product Unit

EPC0698005 EPY0001054 EPC0700000 EPC0980650 EPY0001197 EPC0980651 EPC0984100 EPC0990000 EPY0000073 EPY0000074 EPC1000000 EPC1050000 EPY0000104 EPC1100000 EPY0001298 EPY0001299 EPC1200000 EPC1300000 EPC1350000 EPC1400000 EPC1425000 EPC1435000 EPC1450000 EPC1500000 EPY0000476 EPC1510000 EPC1520000 EPC1540000 EPC1530000 EPY0000569 EPC2223030 EPC1650000 EPC1700000 EPC1800000 EPY0000436 EPY0000437 EPC1900000 EPY0000507

Cellulose acetate butyrate - Reference Spectrum Cellulose acetate phthalate Cephaeline hydrochloride Cetirizine dihydrochloride Cetirizine for peak identification Cetirizine impurity A (RS)-1-[(4-chlorophenyl)phenylmethyl]piperazine Cetostearyl isononanoate - Reference Spectrum Cetyl alcohol Cetyl palmitate 15 Cetyl palmitate 95 Cetylpyridinium chloride Chenodeoxycholic acid Chitosan hydrochloride Chlorambucil Chlorambucil for system suitability Chlorambucil with impurity G Chloramphenicol Chloramphenicol dipalmitate Chloramphenicol disodium disuccinate Chloramphenicol palmitate isomer Chloramphenicol sodium succinate Chlorcyclizine hydrochloride Chlordiazepoxide Controlled Substance Chlordiazepoxide hydrochloride Controlled Substance Chlordiazepoxide impurity A 7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-oxide Chlorhexidine Chlorhexidine diacetate Chlorhexidine dihydrochloride Chlorhexidine for performance test Chlorogenic acid 1-(4-Chlorophenyl)-1-phenylethanol Clemastine fumarate impurity C Chloroquine sulphate Chlorothiazide Chlorphenamine maleate Chlorphenamine impurity A 2-(4-chlorophenyl)-4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile Chlorphenamine impurity C (3RS)-3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine Chlorpromazine hydrochloride Chlorpromazine impurity A 3-(2-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1- amine S-oxide (chlorpromazine sulphoxide) Chlorpromazine impurity D 3-(2-chloro-10H-phenothiazin-10-yl)-N-methypropan-1-amine (demethylchlorpromazine) Chlorpromazine impurity E 2-chloro-10H-phenothiazine Chlorpromazine impurity F 3-(4-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine Chlorpropamide Chlorpropamide impurity B 1,3-Dipropylurea

unit 10 mg 15 mg 100 mg 1.01 mg 10 mg unit 250 mg 60 mg 50 mg 20 mg 125 mg 30 mg 100 mg 10 mg 10 mg 500 mg 100 mg 25 mg 100 mg 1500 mg 100 mg 2x50 mg 100 mg 10 mg 50 mg 10 mg 50 mg 50 mg 20 mg 15 mg 200 mg 100 mg 100 mg 0.01 mg 10 mg 200 mg 10 mg

EPY0000479 New EPY0000508 EPY0001449 EPC1905000 EPC1905020

10 mg 10 mg 2 mg 100 mg 50 mg

260

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPC1915000 EPC1950000 EPY0000779 EPC2000000 EPY0001451 EPC2100000 EPC2150000 EPC2155000 EPC2158000 EPY0000280 EPY0000593 EPC2160000 EPY0000040 EPC2162701 EPC2162702 EPC2162700 EPC2163000 EPY0000361 EPC2170000 EPC2174000 EPC2174002

Chlorprothixene hydrochloride Chlortalidone Chlortalidone for peak identification Chlortetracycline hydrochloride Chlortetracycline for system suitability Cholecalciferol Cholecalciferol for system suitability Cholesterol Cholic acid Chondroitin sulfate sodium Chondroitin sulfate sodium (marine) Chymotrypsin BRP Ciclopirox Ciclopirox impurity A (RS)-2-(3-cyclohexyl-5-methyl-4,5-dihydroisoxazol-5-yl)acetic acid Ciclopirox impurity B 6-cyclohexyl-4-methyl-2H-pyran-2-one Ciclopirox olamine Ciclosporin Ciclosporin for system suitability Cilastatin sodium Cilazapril Cilazapril impurity A 1,1-dimethylethyl(1S,9S)-9-[[(S)-1-ethoxycarbonyl-3-phenylpropyl]amino]10-oxo-octahydro-6H-pyridazino[1,2a][1,2]diazepine-1-caboxylate Cilazapril impurity D (1S,9S)-9-[[(R)-1-ethoxycarbonyl-3-phenylpropyl]amino]-10-oxo-octahydro-6Hpyridazino[1,2a][1,2]diazepine-1-carboxylic acid Cimetidine Cimetidine hydrochloride Cimetidine for peak identification Cimetidine for system suitability Cinchocaine hydrochloride Cineole Cinnarizine Ciprofibrate Ciprofibrate for system suitability Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride for peak identification Ciprofloxacin impurity A 7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic acid (fluoroquinolonic acid) Cisplatin Cisplatin impurity A trans-diamminedichloroplatinium (II) Cisplatin impurity B amminetrichloroplatinate (-) Citalopram hydrobromide Citalopram hydrochloride Citalopram for system suitability Citric acid (anhydrous) Citric acid monohydrate Cladribine
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

50 mg 150 mg 1.017 mg 100 mg 20 mg 500 mg 1 mL 100 mg 60 mg 250 mg 100 mg 100 mg 100 mg 20 mg 20 mg 150 mg 120 mg 5 mg 10 mg 50 mg 25 mg

EPC2174005

10 mg

EPC2175000 EPC2175500 EPY0001130 EPY0001146 EPC2177000 EPY0000176 EPC2180000 EPY0000362 EPY0000363 EPY0000198 EPC2190000 EPY0000199 EPC2190050

50 mg 100 mg 10 mg 0.5085 mg 60 mg 180 mg 100 mg 5 mg 5 mg 20 mg 100 mg 10 mg 10 mg

EPC2210000 EPY0001018 EPY0001019 EPY0001008 EPY0001007 EPY0000855 EPA1202000 EPC2219000 EPY0000639


Edition 2012/2013

100 mg 10 mg 10 mg 5 mg 5 mg 0.06 mg 50 mg 50 mg 50 mg
261

European Pharmacopoeia
Code Product Unit

EPY0000609 EPY0000610 EPY0000320 EPY0000321 New EPY0001193 EPY0000269 EPC2221000 EPC2223000 EPC2248000 EPC2248010 EPC2250000 EPC2269000 EPY0000364 EPY0000205 EPY0000241 EPY0000559 EPY0000570 EPY0000571

Cladribine for peak identification Cladribine impurity C 2-chloro-7H-purin-6-amine Clarithromycin Clarithromycin for peak identification Clazuril Clazuril for system suitability Clebopride malate Clemastine fumarate Clenbuterol hydrochloride Clenbuterol impurity B 1-(4-amino-3,5-dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone (clenbuterol ketone) Clindamycin hydrochloride Clindamycin phosphate Clioquinol Clobazam - Reference Spectrum Clobazam impurity A 7-chloro-5-phenyl-1,5-dihydro-1,5-dihydro-3H-1,5-benzodiazepine-2,4-dione Clobetasol propionate Clobetasol for peak identification Clobetasol impurity J (17R)-4'-chloro-5'-ethyl-9-fluoro-11-hydroxy-16-methylspiro[androsta-1,4-diene17,2'(3'H)-furan]-3,3'-dione (17 alpha-spiro compound) Clobetasone butyrate Clobetasone butyrate for system suitability Clodronate disodium tetrahydrate Clodronate impurity D (chloromethylene)bis(phosphonic acid) Clofazimine Clofazimine for system suitability Clofibrate Clomifene citrate Clomifene citrate for performance test Clomipramine hydrochloride Clomipramine impurity C 3-(3-chloro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine Clomipramine impurity D 3-(3,7-dichloro-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl) N,N-dimethylpropan-1-amine Clomipramine impurity F 3-chloro-10,11-dihydro-5H-dibenzo[b,f]azepine Clonazepam Controlled Substance Clonazepam - Reference Spectrum Clonazepam impurity B 3-Amino-4-(2-chlorophenyl)-6-nitro-1H-quinolin-2-one Clonidine hydrochloride Clonidine impurity B 1-acetyl-2-[(2,6-dichlorophenyl)amino]-4,5-dihydro-1H-imidazole Clopamide Clopamide for system suitability Clopidogrel hydrogen sulfate Clopidogrel for system suitability Clopidogrel impurity A (2S)-(2-chlorophenyl)[6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]acetic acid Closantel sodium dihydrate

10 mg 5 mg 160 mg 40 mg 10 mg 10 mg 100 mg 100 mg 30 mg 10 mg 200 mg 250 mg 5 mg unit 10 mg 40 mg 2 mg 0.4 mg

EPC2285000 EPY0001137 EPY0000888 EPY0000885 EPY0000313 EPY0000358 EPC2300000 EPC2320000 EPC2332000 EPC2360000 EPY0000132 EPY0000133

50 mg 30 mg 5 mg 5 mg 150 mg 10 mg 0.5 mL 50 mg 50 mg 100 mg 10 mg 10 mg

EPY0000134 EPC2385000 EPY0000286 EPC2385015 EPC2400000 EPY0000801 EPY0000833 EPY0000848 EPY0001333 EPY0001334 EPY0001335 EPY0000392

5 mg 50 mg unit 5 mg 100 mg 20 mg 40 mg 10 mg 60 mg 100 mg 10 mg 20 mg

262

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000393 EPC2424400 EPC2424550 EPC2424500 EPC2425600 EPC2430000 EPY0000818 EPY0000849 EPC2450000 EPC2460000 EPY0000758 New EPY0001472 EPY0000162 EPC2480000 EPY0000722 EPC2500000 EPY0000334

Closantel for system suitability Clostridia (multi-component) rabbit antiserum (for vaccines-vet.use) BRP Clostridium tetani guinea pig antiserum (for vaccines-human use) BRP Clostridium tetani guinea pig antiserum (for vaccines - vet.use) BRP Clostridium tetani rabbit antiserum (for vaccines - vet.use) BRP Clotrimazole Clotrimazole impurity E (2-chlorophenyl)phenylmethanone (2-chlorobenzophenone) Clotrimazole for peak identification Cloxacillin sodium Clozapine Clozapine for peak identification Coagulation Factors V, VIII, XI and XIII plasma Cocaine hydrochloride - Reference Spectrum Cocoyl caprylocaprate Codeine Controlled Substance Codeine - Reference Spectrum Codeine impurity A 7,8-didehydro-4,5-epoxy-3,6-dimethoxy-17-methylmorphinan (o-methylcodeine) Controlled Substance Codeine hydrochloride dihydrate - Reference Spectrum Codergocrine mesilate Colchicine Colchicine for system suitability Colestyramine Colistimethate sodium Colistin sulfate Colistin sulfate for microbiological assay Copovidone - Reference Spectrum Cortisone acetate Coumarin Cotton wool standard for neps Crospovidone Crotamiton Crotamiton impurity A N-ethyl-N-(2-methylphenyl)but-3-enamide Cyanidin chloride Cyanocobalamin Cyclizine hydrochloride Cyclizine impurity A 1-methylpiperazine Cyclizine impurity B diphenylmethanol (benzhydrol) Cyclobenzaprine hydrochloride Cyclopentolate hydrochloride Cyclopentolate for system suitability Cyclophosphamide Cyproheptadine hydrochloride Cyproheptadine impurity C 5-(1-methylpiperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5-ol

20 mg 1 mg 3x1 mg 1 mg 1 mg 100 mg 15 mg 1 mg 200 mg 60 mg 0.41 mg 2x1 mg unit 40 mg 20 mg unit 10 mg

EPC2500100 EPC2510000 EPC2580000 EPY0000209 EPY0000374 EPC2600000 EPY0000277 EPC2700000 EPC2725000 EPC2800000 EPY0000438 EPC2900000 EPY0001053 EPC2970000 EPC2970005 EPY0001061 EPC3000000 EPC3090000 EPY0000886 EPY0000887 EPC3200000 EPC3245000 EPY0001088 EPC3250000 EPC3280000 EPY0001095

unit 60 mg 15 mg 10 mg 10 mg 20 mg 25 mg 25 mg unit 250 mg 80 mg 1000 mg 5 mg 100 mg 70 mg 20 mg 20 mg 50 mg 15 mg 10 mg 100 mg 2x50 mg 60 mg 50 mg 30 mg 5 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

263

European Pharmacopoeia
Code Product Unit

EPC3283000 EPY0001390 EPY0001223 EPC3290000 EPC3300000 EPC3350000 EPY0000733 EPY0000734 EPY0000735 EPD0070000 EPY0000600 EPD0100000 EPD0125000 EPD0120000 EPD0160000 EPD0201000 EPY0000611 EPD0300000 EPD0350000 EPY0000228 EPD0406200 EPD0430000 EPD0431000 EPY0001321 EPD0480000 EPY0000879 EPY0000807 EPD0500000 EPD0600000 EPD0630000 EPD0650000 EPY0000509 EPY0000510 EPD0400000 EPY0000001 EPD0660020 EPD0700000 EPY0001177 EPD0710000 EPY0001169 EPY0000538 EPY0000511 EPD0718000 EPD0720000 New EPY0001477 EPD0720800

Cyproterone acetate Cyproterone acetate for peak identification Cyproterone impurity mixture Cysteine hydrochloride monohydrate Cystine Cytarabine Dacarbazine Dacarbazine impurity A 3,7-dihydro-4H-imidazo[4,5-d]-1,2,3-triazin-4-one (2-azahypoxanthine) Dacarbazine impurity B 5-amino-1H-imidazole-carboxamide Dalteparin sodium Danaparoid sodium Dapsone Daunorubicin hydrochloride Daunorubicinone Daunorubicin aglycone Deferoxamine mesilate Dehydrohexetidine 2-ethyl-N-[[1-(2-ethylhexyl)-4-methyl-4,5-dihydro-1H-imidazol-4-yl]methyl]hexan-1-amine Dembrexine hydrochloride monohydrate Demeclocycline hydrochloride N-Demethylerythromycin A Demethylflumazenil - Reference Spectrum Deptropine citrate Dequalinium chloride Dequalinium chloride for performance test Dermatan sulfate and oversulfated chondroitin sulfate Desacetylvinblastine Desflurance - Reference Spectrum Desflurane impurity A 1,1'-oxybis(1,2,2,2-tetrafluoroethane) Desipramine hydrochloride Deslanoside Desmethylmetrifonate Desmopressin Desogestrel Desogestrel for system suitability Desoxycortone acetate Detomidine hydrochloride Detomidine impurity B (RS)-(1-benzyl-1H-imidazol-5-yl)(2,3-dimethylphenyl)methanol Dexamethasone Dexamethasone for system suitability Dexamethasone acetate Dexamethasone acetate impurity E 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregn-4-en-21-yl acetate Dexamethasone isonicotinate Dexamethasone isonicotinate for impurity C identification Dexamethasone pivalate Dexamethasone sodium phosphate Dexamethasone sodium phosphate for peak identification Dexchlorpheniramine maleate

30 mg 5 mg 0.01 mg 50 mg 100 mg 150 mg 20 mg 20 mg 10 mg 250 mg 10 mg 100 mg 100 mg 10 mg 30 mg 50 mg 10 mg 100 mg 10 mg unit 60 mg 50 mg 50 mg 1 mL 2x1 mg unit 1 mL 100 mg 150 mg 30 mg 0.98 mg 50 mg 10 mg 100 mg 100 mg 20 mg 50 mg 10 mg 100 mg 0.013 mg 10 mg 10 mg 50 mg 100 mg 10 mg 60 mg

264

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPD0730000 EPD0731000 EPD0731005 EPD0732000 EPD0733000 EPD0734000 EPD0735000 EPD0736000 EPD0737000 EPD0738000 EPD0739000 EPY0000744 EPD0740000 EPY0000261 EPY0001058 EPY0001150 EPD0940000 EPY0000596 EPD0950000 EPD0970000 EPD1000000 EPY0000480 EPY0000481 EPD1010000 EPY0000275 EPY0000259 EPY0000264 EPD1039990 EPS0765000 EPD1040000 EPD1050000 EPD1060000 EPY0000439 EPY0000440 EPY0000441 EPY0000442

Dexpanthenol Dextran Dextran 1 Dextran Vo Dextran 4 for calibration Dextran 10 for calibration Dextran 40 for calibration Dextran 70 for calibration Dextran 250 for calibration Dextran 40 for performance test Dextran 60/70 for performance test Dextranomer Dextromethorphan hydrobromide Dextromethorphan impurity A ent-3-methoxymorphinan Dextropropoxyphene hydrochloride Controlled Substance Dextropropoxyphene for system suitability Controlled Substance Diazepam Controlled Substance Diazepam for system suitability Controlled Substance Diazoxide Dibenzocycloheptene Dibenzosuberone Dibrompropamidine diisetionate Dibrompropamidine for system suitability Dibutyl phthalate Dichlorodiaminocyclohexaneplatinum Diclazuril for system suitability Diclazuril for veterinary use - Reference Spectrum Diclofenac potassium Diclofenac sodium Diclofenac impurity A 1-(2,6-dichlorophenyl)-indolin-2-one Dicloxacillin sodium Dicycloverine hydrochloride Didanosine Didanosine for system suitability Didanosine impurity A 1,7-dihydro-6H-purin-6-one (hypoxanthine) Didanosine impurity G 9-(2,3-dideoxy--D-glycero-pentofuranosyl)-9H-purin-6-amine (2',3'-dideoxyadenosine) Dienestrol Diethanolamine fusidate Diethylcarbamazine citrate Diethylene glycol (monoethyl ether) - Reference Spectrum Diethyl phthalate Diethylstilbestrol Diethylstilbestrol dimethyl ether Diethylstilbestrol monomethyl ether Difloxacin hydrochloride Difloxacin impurity G 7-chloro-6-fluoro-1-(4-fluorophenyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid Diflunisal
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg 25 mg 50 mg 10 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 50 mg 100 mg 5 mg 10 mg 5 mg 30 mg 0.5 mg 50 mg 20 mg 100 mg 10 mg 20 mg 1 mL 10 mg 20 mg unit 100 mg 100 mg 0.005 mg 250 mg 100 mg 10 mg 10 mg 10 mg 10 mg

EPD1200000 EPD1250000 EPD1300000 EPY0000217 EPD1410000 EPD1500000 EPD1600000 EPD1700000 New EPY0001423 New EPY0001429 EPD1750000
Edition 2012/2013

150 mg 50 mg 250 mg unit 1 mL 100 mg 10 mg 10 mg 60 mg 15 mg 30 mg


265

European Pharmacopoeia
Code Product Unit

EPD1800000 EPY0000640 EPD1900000 EPY0000554 EPD1940001 EPY0000232 EPY0000216 EPY0000053 EPD1945000 EPD1950000 EPY0000831 EPD1952000 EPD1954000 EPY0000544 EPY0000482 EPD1980000 New EPY0001439

Digitoxin Digoxigenin Digoxin Digoxin for peak identification Dihydralazine sulphate (hydrated) - Reference Spectrum Dihydralazine for system suitability Dihydrocodeine hydrogen tartrate - Reference Spectrum 17 alpha-dihydroequilin Dihydroergocristine mesilate Dihydroergotamine mesilate Dihydroergotamine for peak identification Dihydroergotamine tartrate Dihydrostreptomycin sulfate (for LC assay) Dihydrotachysterol Dihydrotachysterol for system suitability Diltiazem hydrochloride Diltiazem impurity F (2S,3S)-5-[2-(dimethylamino)ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5benzothiazepin-4(5H)-one Diltiazem for system suitability Dimenhydrinate N,N-Dimethylacetamide - Reference Spectrum Dimenhydrinate for peak identification Dimethyl sulfoxide Dimeticone Dimetindene maleate Dinoprost trometamol Dinoprostone Dinoprostone impurity C (E)-7-[(1S,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxyoct-1-enyl]5-oxocyclopentyl]-hept-5-enoic acid (5-trans-PGE2;(5E)-PGE2) Diosmin Diosmin for system suitability Diphenhydramine hydrochloride Diphenhydramine impurity A 2-(diphenylmethoxy)-N-methylethanamine Diphenoxylate hydrochloride - Reference Spectrum Diphenoxylate hydrochloride Controlled Substance Diphenoxylate for system suitability Controlled Substance Diphtheria toxin BRP Diphtheria vaccine (absorbed) BRP Dipivefrine hydrochloride Dipivefrine for system suitability Dipotassium clorazepate - Reference Spectrum Diprophylline Dipyridamole Dipyridamole for peak identification Dirithromycin Disodium edetate Disopyramide Disopyramide phosphate Disulfiram

200 mg 5 mg 30 mg 10 mg unit 10 mg unit 10 mg 250 mg 100 mg 10 mg 150 mg 25 mg 30 mg 5 mg 300 mg 10 mg

EPY0001141 EPD2000000 EPY0000234 EPY0001103 EPD2050000 EPD2200000 EPD2205000 EPD2255000 EPD2250000 EPD2250015

10 mg 100 mg unit 1 mg 1 mL 200 mg 50 mg 60 mg 100 mg 10 mg

EPY0000094 EPY0000095 EPD2600000 EPY0000135 EPD2630000 New EPY0001415 New EPY0001430 EPY0000258 EPD2700000 EPY0000376 EPY0000394 EPD2750100 EPD2800000 EPD2850000 EPY0000802 EPD2880000 EPD2900000 EPD2920000 EPD2922000 EPD2950000

70 mg 5 mg 100 mg 10 mg unit 15 mg 10 mg 1 mL 32 mg 100 mg 10 mg unit 100 mg 50 mg 2 mg 100 mg 100 mg 100 mg 100 mg 100 mg

266

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPD2953000 EPD2953025 EPD2953050 EPD2954000 EPY0001239 New EPY0001452

Dithranol Dithranol impurity C Dithranol-dimer 4,4',5,5'-tetrahydroxy-9,9'-bianthracenyl-10,10'(9H,9'H)-dione Dithranol impurity D 1-hydroxyanthracen-9(10H)-one Dobutamine hydrochloride Dobutamine impurity mixture Docetaxel impurity E 5,20-epoxy-4-(acetyloxy)-1,7,10,13-tetrahydroxy-9-oxotax-11-en-2-yl benzoate (10-desacetyl-baccatin III) Docetaxel trihydrate Docetaxel for system suitability Anhydrous Docetaxel Docosahexaenoic acid ethyl ester Docusate sodium - Reference Spectrum Dodecyl gallate Domperidone Domperidone maleate Dopamine hydrochloride Dopexamine dihydrochloride Dopexamine impurity B 2-methoxy-4-[2-[[6-[(2-phenylethyl)hexyl]amino]ethyl]phenol Dopexamine impurity F 4-Chloro-5-[2-[[6-[(2-phenylethyl)amino]hexyl]amino]ethyl]benzene-1,2-diol Dorzolamide hydrochloride Dorzolamide impurity A (4R,6R)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b] thiopyran-2-sulphonamide 7,7-dioxide Dorzolamide for system suitability Dosulepin hydrochloride Dosulepin impurity A (E)-3-(6,11-dihydrodibenzo[b,e]thiepin-11-ylidene)N,N'-dimethylpropan-1-amine S-oxide Doubleteeth pubescent angelica root Doxapram hydrochloride Doxapram impurity B (4RS)-1-ethyl-4-[2-[(2-hydroxyethyl)amino]ethyl]-3,3-diphenylpyrolidin-2-one Doxazosin mesilate Doxazosin impurity D 6,7-dimethoxyquinazoline-2,4(1H,3H)-dione Doxazosin impurity F 2-chloro-6,7-dimethoxyquinazolin-4-amine Doxepin hydrochloride Doxepin for system suitability Doxorubicin hydrochloride Doxycycline hyclate Doxylamine hydrogen succinate - Reference Spectrum Doxylamine impurity A N,N-dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4-yl)ethoxy]ethanamine Droperidol Drospirenone Drospirenone impurity E 3-oxo-6alpha,7alpha,15alpha,16alpha-tetrahydro-3'H,3''H-dicyclopropa [6,7:15,16]pregn-4-ene-21,17-carbolactone (17-epidrospirenone) Duloxetine hydrochloride Duloxetine for system suitability
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

55 mg 20 mg 20 mg 100 mg 0.1 mg 15 mg

EPY0001133 EPY0001155 New EPY0001466 EPD2954600 EPD2954500 EPY0000365 EPD2955000 EPD2957000 EPD2960000 EPY0000612 EPY0000613 EPY0000614 EPY0000726 EPY0000727

160 mg 10 mg 15 mg 150 mg unit 30 mg 150 mg 150 mg 50 mg 10 mg 10 mg 10 mg 50 mg 5 mg

EPY0000750 EPD2962000 EPD2962005

5 mg 100 mg 50 mg

EPY0001385 EPD2963000 EPY0000208 EPY0000553 EPY0000551 EPY0000552 EPY0000838 EPY0000851 EPD2975000 EPD3000000 EPY0000163 EPY0000160 EPD3100000 EPY0001105 EPY0001115

500 mg 50 mg 10 mg 60 mg 10 mg 10 mg 5 mg 1 mg 150 mg 50 mg unit 10 mg 150 mg 60 mg 0.06 mg

New EPY0001453 New EPY0001454


Edition 2012/2013

120 mg 40 mg
267

European Pharmacopoeia
Code Product Unit

EPY0001455 EPY0001004 EPY0001005 EPY0001006 EPY0000249 EPY0000247 EPY0000248 EPY0001236 EPY0000254 EPE0050000 EPE0085000 EPY0000537 EPY0000512 EPE0100000 EPE0110000 EPE0109000 EPY0001211 EPY0000615 EPY0000629 EPY0000678

Duloxetine impurity A (3R)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Dydrogesterone Dydrogesterone impurity A 9,10-pregna-4,6,8(14)-triene-3,20-dione Dydrogesterone impurity B pregna-4,6-diene-3,20-dione Ebastine - Reference Spectrum Ebastine impurity C 4-(diphenylmethoxy)piperidine Ebastine impurity D 1-[4-(1,1-dimethylethyl)phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one Econazole Econazole for system suitability Econazole nitrate Eicosapentaenoic acid ethyl ester Emedastine difumarate Emedastine impurity E 1-(2-ethoxyethyl)-2-(hexahydro-1H-1,4-diazepin-1yl)benzimidazole Emetine hydrochloride Enalapril for system suitability Enalapril maleate Enalapril impurity mixture Enalaprilat dihydrate Enalaprilat for system suitability Enalaprilat impurity G (2SR)-2-[(3SR,8aRS)-3-methyl-1,4-dioxohexahydropyrrolo [1,2-a]pyrazin-2(1H)-4-phenylbutanoic acid Enilconazole Enilconazole impurity E (1RS)-1-(2,4-dichlorophenyl)-2-(-1H-imidazol-1-yl)ethanol Endotoxin standard BRP Enoxaparin sodium Enoxolone Enrofloxacin Enrofloxacin for system suitability Entacapone Entacapone impurity A Z isomer of entacapone Enterokinase BRP Ephedrine hydrochloride (racemic) Drug Precursor Ephedrine hydrochloride Drug Precursor 4-Epianhydrotetracycline hydrochloride 4-Epidemeclocycline hydrochloride 6-Epidoxycycline hydrochloride Epinastine hydrochloride Epinastine hydrochloride for system suitability 4-Epioxytetracycline Epirubicin hydrochloride 4-Epitetracycline hydrochloride Equilin Eq influenza Subtype 1 Strain A/eq/Newmarket/77 Horse Antiserum BRP Eq influenza Subtype 2 American-like/Newmarket Horse Antiserum BRP Eq Influenza Subtype 2 European-like/Newmarket Horse Antiserum BRP

10 mg 50 mg 6 mg 5 mg unit 10 mg 10 mg 10 mg 20 mg 100 mg 200 mg 10 mg 10 mg 100 mg 20 mg 50 mg 0.06 mg 100 mg 10 mg 0.005 mg

EPY0000136 EPY0000137 EPE0150000 EPE0180000 EPE0180500 EPY0001259 EPY0001160 EPY0001249 EPY0001250 EPE0200000 EPE0305000 EPE0300000 EPE0400000 EPE0440000 EPE0500000 EPY0001139 EPY0001128 EPE0530000 EPE0550000 EPE0600000 EPY0000052 EPE0850010 EPE0850021 EPE0850022

60 mg 20 mg 10 mg 200 mg 100 mg 5 mg 10 mg 160 mg 10 mg 200 mg 50 mg 150 mg 20 mg 20 mg 50 mg 20 mg 10 mg 40 mg 100 mg 30 mg 15 mg 3x1 mg 3x1 mg 3x1 mg

268

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000712 New EPY0001325 EPE0900000 EPE1000000 EPE1100000 EPE1200000 EPY0000051 EPY0000177 EPE1300000 EPE1305000 EPE1310000 EPE1320000 EPE1400000 EPE1500000 EPE1500800 EPE1515000 EPY0000324 EPY0000338 EPY0001028 EPY0000749 EPE1600000 EPY0000852 EPY0000045 EPE1620000 EPY0000314 EPY0000046 EPE1680000 EPE1680005 EPE1700000 EPE1800000 EPY0001263 EPE1830000 EPE1840000 EPE1850000 EPY0000803 EPA1202800 EPE1860100 EPE1900000 EPY0001124 EPE2000000 EPE2150000 EPE2250000 EPE2195000 EPE2195900 EPE2202000 EPE2205500 EPY0000617 EPE2300000 EPE2400000
Edition 2012/2013

Eq Influenza Subtype 2 American-like/South Africa Horse Antiserum BRP Equisetum palustre Ergocalciferol Ergometrine maleate Drug Precursor Ergosterol Ergotamine tartrate Drug Precursor Erysipelas ELISA coating antigen BRP Erythritol Erythromycin for microbiological assay Erythromycin A Erythromycin B Erythromycin C Erythromycin estolate Erythromycin ethylsuccinate Erythromycin stearate Erythropoietin BRP Esketamine hydrochloride - Reference Spectrum Esketamine impurity D (2R)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone ((R)-ketamine) Esomeprazole magnesium trihydrate Essential oil Estradiol benzoate Estradiol benzoate for system suitability Estradiol butyrate Estradiol hemihydrate Estradiol for peak identification Estradiol valerate Estriol Estriol impurity A 9,11-didehydroestriol Estrone Etacrynic acid Etacrynic acid for system suitability Etamsylate Ethacridine lactate monohydrate Ethambutol hydrochloride Ethambutol for system suitability Ethanol (anhydrous) - Reference Spectrum Ethanol 96% - Reference Spectrum Ethinylestradiol Ethinylestradiol for system suitability Ethionamide Ethosuximide Ethosuximide impurity A (2RS)-2-ethyl-2-methylbutanedioic acid Ethyl acetate - Reference Spectrum Ethylcellulose - Reference Spectrum 1-N-Ethylgaramin sulfate 1,1'-Ethylidenebistryptophan Ethyl indole-3-carboxylate Ethylmorphine hydrochloride - Reference Spectrum Ethylnicotinamide
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

3x1 mg 200 mg 500 mg 50 mg 20 mg 100 mg 0.4 mg 1000 mg 250 mg 250 mg 50 mg 50 mg 100 mg 10 mg 50 mg 37.5 mg unit 10 mg 10 mg 1000 mg 250 mg 10 mg 10 mg 100 mg 10 mg 50 mg 50 mg 20 mg 15 mg 100 mg 10 mg 30 mg 50 mg 250 mg 10 mg unit unit 200 mg 25.31 mg 100 mg 30 mg 30 mg unit unit 50 mg 2x0.00167 mg 10 mg unit 150 mg
269

European Pharmacopoeia
Code Product Unit

EPE2425000 EPE2450000 EPE2451000 EPE2451010 EPY0000572 EPE2470000 EPE2470050 EPY0000768 EPE2499900 EPE2499901 EPE2499914 EPE2500000 EPE2503000 EPE2503004 EPE2600000 EPY0001365 EPE5000000 EPF0005000 EPY0000382 EPY0000409 EPY0000556 EPY0000660 EPY0000731 EPY0000732 EPF0030000 EPY0000415 EPF0040000 EPF0040010 EPF0040020 EPF0041000 EPF0048000 EPF0048005 EPF0048010 EPF0048035

Ethyl parahydroxybenzoate Etifenin Etilefrine hydrochloride Etilefrine impurity A 2-ethylamino-1-(3-hydroxyphenyl)ethanone Etidronate disodium Etodolac Etodolac impurity H 2-(7-ethylindol-3-yl)ethanol Etodolac for peak identification Etofenamate Etofenamate for peak identification Etofenamate impurity G 2-hydroxyethyl 2-[[3-(trifluoromethyl)phenyl]amino]-benzoate Etofylline Etomidate Etomidate impurity B methyl 1-[(1RS)-1-phenylethyl]-1H-imidazole-5-carboxylate Etoposide Etoposide for system suitability Eugenol Famotidine Famotidine for system suitability Famotidine impurity D 3-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanamide Febantel Febantel for system suitability Felbinac Felbinac impurity A 4-acetyl biphenyl Felodipine Felypressin Fenbendazole Fenbendazole impurity A methyl(1H-benzimidazol-2-yl)carbamate Fenbendazole impurity B methyl[5(6)-chlorobenzimidazol-2-yl]carbamate Fenbufen Fenofibrate Fenofibrate impurity A (4-chlorophenyl)(4-hydroxyphenyl)methanone Fenofibrate impurity B 2[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (fenofibric acid) Fenofibrate impurity G 1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl] oxy]-2-methylpropanoate Fenoterol for peak identification Fenoterol hydrobromide Fentanyl - Reference Spectrum Fentanyl for system suitability Controlled Substance Fentanyl citrate - Reference Spectrum Fenticonazole nitrate Fenticonazole impurity D (RS)-1-[2-(2,4-dichlorophenyl)-2-hydroxyethyl]-3[4-(phenyl suphanyl)benzyl]imidazolium nitrate

150 mg 25 mg 75 mg 20 mg 10 mg 60 mg 10 mg 10 mg 40 mg 15 mg 20 mg 100 mg 50 mg 25 mg 150 mg 10 mg 500 L 100 mg 10 mg 10 mg 110 mg 10 mg 10 mg 20 mg 120 mg 0.994 mg 150 mg 20 mg 20 mg 100 mg 100 mg 20 mg 10 mg 25 mg

EPY0000756 EPF0050000 EPF0054990 New EPY0001509 EPF0055000 EPF0060000 EPF0060040

1.2 mg 100 mg unit 25 mg unit 50 mg 20 mg

270

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Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPF0100000 EPY0001013 EPY0000789 EPY0000751

Ferrous gluconate Ferulic acid Fexofenadine hydrochloride Fexofenadine impurity A 2-[4-[4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butanoyl]phenyl]-2-methylpropanoic acid Fexofenadine impurity B 2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2methylpropanoic acid Fexofenadine impurity C (1RS)-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)phenyl]butan-1-ol Filgrastim Finasteride Finasteride for system suitability Flavoxate hydrochloride Flavoxate impurity A 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylic acid Flavoxate impurity B ethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate Flecainide acetate Flecainide impurity A 3-[2,5-bis(2,2,2-trifluoroethoxy)phenyl]-1,5,6,7,8,8ahexahydroimidazo[1,5-a]pyridine Flecainide impurity B (RS)-(piperidin-2-yl)methanamine Flecainide for system suitability Flubendazole Flubendazole for system suitability Flucloxacillin magnesium octahydrate Flucloxacillin impurity C 6-aminopenicillanic acid Flucloxacillin impurity D 3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic acid Flucloxacillin impurity E 6-aminopenicillanic acid flucloxacillin amide Flucloxacillin sodium Fluconazole Fluconazole for peak identification Fluconazole impurity B 2-[2-fluro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol Fluconazole impurity C 1,1-(1,3-phenylene)di-1H-1,2,4-triazole Flucytosine Flucytosine for system suitability Fludarabine phosphate Fludrocortisone acetate Flumazenil - Reference Spectrum Flumazenil impurity B ethyl 8-hydroxy-5-methyl-6-oxo-5,6-dihydro-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylate Flumequine Flumequine impurity B ethyl(RS)-9-fluoro-5-methyl-1-oxo-6,7-dihydro-1H,5H-benzo[i,j] quinolizine-2-carboxylate Flumetasone pivalate Flunarizine dihydrochloride Flunarizine dihydrochloride - Reference Spectrum
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg 20 mg 60 mg 5 mg

EPY0000752

0.01 mg

EPY0000753 EPY0001173 EPY0000090 EPY0000091 EPY0000736 EPY0000737 EPY0000738 EPF0120000 EPF0120005

5 mg 0.2 mL 60 mg 100 mg 10 mg 10 mg 10 mg 200 mg 50 mg

EPF0120010 EPY0001274 EPY0000138 EPY0000139 EPY0000892 EPY0000889 EPY0000890 EPY0000891 EPF0150000 EPY0000557 EPY0000558 EPY0000573 EPY0000574 EPF0175000 EPY0001262 EPY0000419 EPF0180000 EPF0188000 EPY0000335

25 mg 10 mg 25 mg 20 mg 5 mg 5 mg 5 mg 5 mg 250 mg 50 mg 10 mg 10 mg 5 mg 100 mg 10 mg 120 mg 100 mg unit 5 mg

EPF0189000 EPF0189020

60 mg 0.1 mg

EPF0188500 EPF0189900 EPY0000265


Edition 2012/2013

100 mg 100 mg unit


271

European Pharmacopoeia
Code Product Unit

EPY0000266 EPF0190000 EPY0000169 EPY0000443 EPY0000444 EPY0000445 EPF0200000 EPF0230000 EPY0000796 EPY0000804 EPY0000454 EPF0245000 EPF0250000 EPY0000762 EPY0000763 EPY0000764 EPY0000765 EPY0000791 EPF0253000 EPF0253020 EPF0253030 EPY0000064 EPY0000067

Flunarizine dihydrochloride for system suitability Flunitrazepam Controlled Substance Flunitrazepam - Reference Spectrum Flunixin meglumine Flunixin impurity B 2-methyl-3-(trifluoromethyl)aniline Flunixin impurity C ethyl 2-chloropyridine-3-carboxylate Fluocinolone acetonide Fluocortolone pivalate Fluorescein Fluorescein impurity C 2-(2,4-dihydroxybenzoyl)benzoic acid Diacetylfluorescein Fluoresceine sodium - Reference Spectrum Fluorouracil Fluorouracil impurity A pyrimidine-2,4,6(1H,3H,5H)-trione (barbituric acid) Fluorouracil impurity B dihydropyrimidine-2,4,5(3H)-trione (isobarbituric acid or 5-hydroxyuracil) Fluorouracil impurity C pyrimidine-2,4(1H,3H)-dione (uracil) Fluorouracil impurity F 2-ethoxy-5-fluoropyrimidin-4(1H)-one (2-ethoxy-5-fluorouracil) Fluorouracil impurity mixture Fluoxetine hydrochloride Fluoxetine impurity B methyl(3-phenylpropyl)amine Controlled Substance Fluoxetine impurity C (RS)-methyl-[3-phenyl-3-(3-trifluoromethylphenoxy)-propyl]amine Flupentixol dihydrochloride Flupentixol impurity D 2-[2-[4-[3-[(EZ)-2-(trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl] piperazin-1-yl]ethoxy]ethanol Flupentixol impurity F 2-[4-[(EZ)-3-[(9RS)-2-(trifluoromethyl)-9H-thioxanthen-9-yl)prop-2-enyl]piperazin-1-yl]ethanol Fluphenazine decanoate Fluphenazine enantate Fluphenazine dihydrochloride Fluphenazine impurity mixture Fluphenazine octanoate Fluphenazine sulphoxide Flurazepam monohydrochloride - Reference Spectrum Flurbiprofen Flurbiprofen impurity A (2RS)-2-(biphenyl-4-yl)propanoic acid Fluspirilene Fluspirilene impurity C 8-[4,4-bis((4-fluorophenyl)butyl]-3-(hydroxymethyl)-1phenyl-1,3,8-triazaspiro[4.5]decan-4-one Flutamide Flutamide impurity C N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide Fluticasone propionate

20 mg 100 mg unit 10 mg 10 mg 50 mg 100 mg 100 mg 120 mg 0.01 mg 100 mg unit 40 mg 10 mg 10 mg 10 mg 10 mg 0.0002 mg 250 mg 10 mg 5 mg 100 mg 15 mg

EPY0000078

25 mg

EPF0260000 EPY0000009 EPF0280000 EPY0000708 EPY0000298 EPY0000299 EPY0000211 EPF0285200 EPF0285202 EPY0000236 EPY0000375

60 mg 100 mg 50 mg 0.07 mg 20 mg 10 mg unit 50 mg 20 mg 20 mg 10 mg

EPF0285600 EPF0285603 EPY0000284

50 mg 20 mg 100 mg

272

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Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000221

Fluticasone impurity D S-methyl 6a,9a-difluoro-11b-hydroxy-16a-methyl-3-oxo-17a-propionyloxy-androsta1,4-diene-17-carbothioate (S-methyl derivative) Flutrimazole Flutrimazole impurity B (RS)-(2-fluorophenyl)(4-fluorophenyl)phenylmethanol Fluvastatin sodium Fluvastatin for system suitability Fluvoxamine maleate Fluvoxamine for system suitability Fluvoxamine impurity D 5-methoxy-1-[4-(trifluoromethyl)phenyl]pentan-1-one Foeniculin for peak identification Anise oil Folic acid Folic acid impurity A (2S)-2-[(4-aminobenzoyl)amino]pentanedioic acid (N-(4-aminobenzoyl)-l-glutamic acid) Folic acid impurity D 4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoic acid (pteroic acid) Formoterol fumarate dihydrate Formoterol for impurity I identification Formoterol fumarate for system suitability Formylfolic acid 10-Formylfolic acid Foscarnet sodium hexahydrate Foscarnet impurity B disodium(ethoxyoxydophosphanyl)formate Foscarnet impurity D Ethyl (diethoxyphosphinyl)formate Foscarnet impurity mixture Fosfomycin calcium Fosfomycin sodium - Reference Spectrum Fosfomycin trometamol Fosinopril sodium Fosinopril impurity A (2S,4S)-4-cyclohexyl-1-[[(R)-hydroxy(4-phenylbutyl)phosphoryl] acetyl]pyrrolidine-2-carboxylic acid Fosinopril impurity B (2RS,4RS)-4-cyclohexyl-1-[[(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid Fosinopril impurity C mixture of (2S,4S)-4-cyclohexyl-1-[[(S)-[(1S)-2-methyl-1-(1-oxopropoxy)propoxy](4phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid and (2S,4S)-4-cyclohexyl-1-[[(R)[(1R)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2carboxylic acid Fosinopril impurity D (2S,4R)-4-cyclohexyl-1-[[(R)-[(1S)-2-methyl1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetyl]pyrrolidine-2-carboxylic acid Fosinopril impurity I [(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetic acid Fosinopril impurity K (2S,4S)-4-cyclohexyl-1-(2,2-dimethyl-1-oxopropyl) pyrrolidine-2-carboxylic acid Fosinopril impurity mixture Framycetin sulphate Fructose

20 mg

EPF0290000 EPF0290010 EPY0001090 EPY0001082 EPY0000854 EPY0000853 EPY0000916 EPY0000386 EPF0300000 EPY0001242

100 mg 60 mg 110 mg 0.5 mg 5 mg 1.004 mg 10 mg 100 mg 2x150mg 15 mg

EPY0001243 EPF0372000 EPY0000339 EPY0000340 EPF0380000 EPF0389000 EPF0389004 EPY0001222 EPY0001213 EPY0000782 EPF0399950 EPF0400000 EPY0001227 EPY0001228

70 mg 10 mg 10 mg 10 mg 30 mg 50 mg 10 mg 50 mg 0.012 mg 10 mg unit 1500 mg 60 mg 5 mg

EPY0001229

5 mg

EPY0001230

10 mg

EPY0001231

10 mg

EPY0001232

5 mg

EPY0001233

5 mg

EPY0001212 EPF0450000 EPF0550000

0.02 mg 2x25 mg 100 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

273

European Pharmacopoeia
Code Product Unit

New EPY0001399 New EPY0001413 EPF0600000 EPF0700000 New EPY0001493 EPF0702000 New EPY0001411 EPF1000000 New EPY0001394 New EPY0001384 EPY0001280 EPY0001281 EPY0001348 EPY0001349 EPG0049000 EPG0050000 EPY0001279 EPY0001190 EPY0001201 EPY0001191 EPG0100000 EPG0150000 EPY0001129 EPY0001144 EPY0000675 EPY0000676 EPY0000513 EPY0000514 EPG0200000 EPY0001363 EPY0001112 EPY0001110 EPY0001116 EPY0001012 EPY0001010 EPG0300000 EPG0325000 New EPY0001511 EPG0325010 EPY0000242 EPG0326000 EPG0326004 EPG0326012 EPY0000515

Fulvestrant Fulvestrant for system sitability Fumaric acid Furosemide Furosemide for peak identification Furosemide impurity A 2-chloro-4-(furfurylamino)-5-sulphamoylbenzoic acid Fusidic acid Fusidic acid - Reference Spectrum Fusidic acid for peak identification Fusidic acid impurity mixture Gabapentin Gabapentin impurity A 2-azaspiro[4.5]decan-3-one Gabapentin impurity B (1-cyanocyclohexyl)acetic acid Gabapentin impurity D [1-[(3-oxo-2-azaspiro[4.5]dec-2-yl)methyl]cyclohexyl]acetic acid Galactitol Galactose Galantamine hydrobromide Galantamine natural for system suitability Galantamine racemic mixture Galantamine synthetic for system suitability Gallamine triethiodide Gammacyclodextrin Ganciclovir Ganciclovir impurity mixture Gemcitabine hydrochloride Gemcitabine impurity A 4-aminopyrimidin-2(1H)-one (Cytosine) Gemfibrozil Gemfibrozil for system suitability Gentamicin sulphate Gentamicin for peak identification Gestodene Gestodene for system suitability Gestodene impurity I 13-ethyl-17-hydroxy-5-methoxy-18,19-dinor-5alpha,17alpha-pregn-15-en-20-yn-3-one Ginkgo dry extract for peak identification Ginkgolic Acid Gitoxin Glibenclamide Glibenclamide for peak identification Glibenclamide impurity A 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide Glibenclamide impurity B methyl [[4-[2-[(5-chloro-2-methoxybenzoyl)amino]ethyl]phenyl] sulphonyl]carbamate Gliclazide Gliclazide impurity B 2-nitroso-octahydrocyclopenta[c]pyrrole Gliclazide impurity F 1-(hexahydrocyclopenta[c]pyrrol-2-(1H)-yl-3-[(2-methylphenyl)sulphonyl]urea Glimepiride

120 mg 40 mg 120 mg 100 mg 10 mg 5 mg 10 mg unit 5 mg 0.0475 mg 300 mg 20 mg 20 mg 10 mg 50 mg 60 mg 10 mg 10 mg 10 mg 5 mg 100 mg 50 mg 220 mg 0.005 mg 50 mg 20 mg 5 mg 0.196 mg 2x25 mg 10 mg 100 mg 10 mg 0.01 mg 150 mg 20 mg 30 mg 100 mg 30 mg 10 mg 20 mg 20 mg 25 mg 50 mg 60 mg

274

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000516 EPG0340000 EPG0342000 EPY0000523 EPY0000643 EPY0001140 EPY0000191 New EPY0001406 New EPY0001381 New EPY0001407 EPG0350500 EPG0355000 EPY0000517 EPG0360000 EPG0400000 EPG0400004 New EPY0001391 EPY0000794 EPY0000795 EPG0400006 EPG0400007 EPG0400008 EPG0400101 EPG0400100 EPG0450000 EPY0001308 EPY0001309 EPY0001358 EPY0000433 EPG0460000 EPG0525000 EPY0000125 EPY0000126 New EPY0001473 EPY0000019 EPY0000194 EPG0550000 EPY0000396 EPY0000477

Glimepiride for system suitability Glipizide Glipizide impurity A 4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzene sulphonamide Glipizide impurity C ethyl 2-[4-[(cyclohexylcarbamoyl)sulphamoyl]phenyl]ethyl]carbamate Glipizide impurity D 6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide Glipizide impurity mixture Human glucagon Glucosamine hydrochloride Glucosamine for system suitability Glucosamine sulfate sodium chloride Glucose Glutamic acid Glutathione Glutethimide Controlled Substance Glycerol (85 per cent) - Reference Spectrum Glycerol distearate Glycerol formal Glycerol monocaprylate Glycerol monocaprylocaprate Glycerol monolinoleate Glycerol mono-oleate Glycerol monostearate 40-55 Glyceryl trinitrate - Reference Spectrum Glyceryl trinitrate solution Glycine Glycopyrronium bromide Glycopyrronium for peak identification Glycopyrronium impurity N (3RS)-3-[(2RS)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium Ammonium glycyrrhizate Glycyrrhizate (monoammonium) Gonadorelin Goserelin Gosereline - Reference Spectrum Goserelin for NMR identification 4-D-Ser-goserelin Goserelin validation mixture Gramicidin Granisetron hydrochloride Granisetron impurity A 2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1] non-3-yl]-2H-indazole-3-carboxamide Granisetron impurity B N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide Granisetron impurity E (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-amine Griseofulvin Guaiacol Guaifenesin Halofantrine hydrochloride

0.012 mg 50 mg 10 mg 10 mg 10 mg 0.002 mg 2x2.94mg 10 mg 40 mg 15 mg 100 mg 50 mg 10 mg 50 mg unit 2000 mg 2x20 mg 400 mg 500 mg 2000 mg 2000 mg 2000 mg unit 0.5 mL 50 mg 10 mg 10 mg 10 mg 70 mg 300 mg 5 mg 2 mg unit 14 mg 0.1 mg 1 mg 250 mg 120 mg 1 mg

EPY0000478 EPY0000395 EPG0600000 EPY0000619 EPG0700000 EPY0000117

1 mg 2x15 mg 50 mg 2200 mg 100 mg 125 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

275

European Pharmacopoeia
Code Product Unit

EPY0000118 EPH0100000 New EPY0001517 New EPY0001518 EPH0100100 EPH0150000 EPY0000673 EPY0001287 EPY0001282 EPH0185000 EPH0190000 EPH0200000 EPY0001283 EPH0205010 EPY0001192 EPY0000389 EPH0210010 EPH0215000 EPH0220000 EPY0000063 EPY0000057 EPH0250000 EPH0330000 EPH0325000 EPH0400000 EPH0420000 EPH0500000 EPH0600000 EPH0700000 EPH0750000 EPH0755000 EPH0800000 EPH0830000 New EPY0001383 EPH0837000 EPH0900000 EPY0000219 EPY0000667 EPH0920000 EPH0920500 EPH0950000 EPH0990000 EPH1000000 EPY0000488 EPH1005000 EPH1100000 EPH1110000 EPY0000502 EPH1115000

Halofantrine impurity C [1,3-dichloro-6-(trifluoromethyl)phenantren-9-yl]methanol Haloperidol Haloperidol for system suitability Haloperidol for peak identification Haloperidol decanoate Halothane - Reference Spectrum Harpagoside Heparin calcium for NMR identification Heparin for Physio-Chemical Analysis Heparin Low-Molecular-Mass for assay BRP Heparin Low-Molecular-Mass for calibration CRS Heparin sodium BRP Heparin sodium for NMR identification Hepatitis A vaccine (inactivated,absorbed) Type B BRP Hepatitis A Vaccine (Inactivated, Non-Adsorbed) Hepatitis B vaccine (rDNA) BRP method A (thiomersal free) Hepatitis B vaccine (rDNA) BRP method B Hepatitis C Virus RNA for NAT testing BRP Heptadecanol Heptaminol hydrochloride Heptaminol impurity A (2RS)-6-methylhept-5-en-2-amine alpha-Hexachlorocyclohexane Hexamidine diisetionate Hexetidine Hexobarbital Hexylresorcinol Hide Powder Histamine dihydrochloride Histamine phosphate Histidine Histidine hydrochloride monohydrate Homatropine hydrobromide Homatropine methylbromide Homatropine methylbromide for system suitability L-Homocycsteine thiolactone hydrochloride - Reference Spectrum Human albumin for electrophoresis BRP Human anti-D immunoglobulin BPR Human coagulation factor VII concentrate BRP Human coagulation factor VIII concentrate BRP Human coagulation factor IX concentrate BRP Human hepatisis A immunoglobulin BRP Human immunoglobulin BRP Human immunoglobulin for electrophoresis BRP Human immunoglobulin (molecular size) BRP Human Plasma Pools for NAT Validation Human rabies immunoglobulin BRP Human tetanus immunoglobulin BRP Human vaccinia immunoglobulin Hyaluronidase BRP

10 mg 50 mg 25 mg 25 mg 60 mg unit 1.03 mg 30 mg 300 mg 5x1 mg 25 mg 2 mL 30 mg 3x0.5 mL 3x0.8 mL 2x0.5 mL 2x1 mL 5x40 mg 2x600 mg 150 mg 20 mg 10 mg 50 mg 100 mg 500 mg 100 mg 500 mg 250 mg 250 mg 100 mg 100 mg 100 mg 25 mg 5 mg unit 1 mL unit 2x26 mg 5x37 mg 5x30 mg 3x10 mg 15800 mg 96 mg 3x700 mg 3502 mg 3x170 mg 87 mg 3x1 mL 50 mg

276

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPH1120000 EPY0001151 EPH1200000 New EPY0001494 EPY0000646 EPY0000710 EPH1300000 EPY0001092 EPH1400000 New EPY0001482 EPH1425000 EPH1426000 EPY0000446 EPB0650000 EPH1428000 EPY0000119 EPH1429400 EPY0001322 EPY0001277 EPH1429700 EPH1430000 EPY0000186 EPH1435000 EPY0000011 EPY0000012 EPY0000013 EPY0000483 EPY0000484

Hydralazine hydrochloride Hydrastine hyrochloride Hydrochlorothiazide Hydrochlorothiazide for peak identification Hydrocodone hydrogen tartrate 2.5-hydrate Controlled Substance Hydrocodone for peak identification Controlled Substance Hydrocortisone Hydrocortisone for peak identification Hydrocortisone acetate Hydrocortisone acetate for peak identification Hydrocortisone hydrogen succinate Hydrogenated wool fat Hydromorphone hydrochloride Controlled Substance Hydrous benzoyl peroxide - Reference Spectrum Hydroxocobalamin Hydroxycarbamide Hydroxyethyl salicylate Hydroxyethyl starch (high Mw) Hydroxyethyl starch (medium MW) 4-Hydroxyphenoxymethylpenicillin potassium D-alpha-(4-Hydroxy-phenyl)glycine (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid - Cefadroxyl impurity A Hydroxypropylbetadex Hydroxyzine hydrochloride Hymecromone Hymecromone impurity A Resorcinol Hymecromone impurity B 7-hydroxy-2-methyl-4H-1-benzopyran-4-one Hyoscine Hyoscine impurity A (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl (2S)-3-hydroxy-2phenylpropanoate (norhyoscine) Hyoscine butylbromide Hyoscine butylbromide impurity E (1R,2R,4S,5S,7S)-9-butyl-7-[[(2S)-3-hydroxy-2-phenylpropanoyl]oxy]-3-oxa9-azoni atricyclo[3.3.1.02,4]nonane Hyoscine hydrobromide Hyoscine hydrobromide impurity B (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl(2S)3-hydroxy-2-phenylpropanoate Hyoscyamine sulfate Hyoscyamine impurity E (1R,3s,5S)-8-azabicyclo[3.2.1] oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate Hypromellose phthalate Ibuprofen Ibuprofen impurity B (2RS)-2-(4-Butylphenyl)propionic acid (0,06% solution in Acetonitrile) Ibuprofen impurity F 3-[4-(2-methylpropyl)phenyl]propanoic acid Ibuprofen for peak identification Idoxuridine Ifosfamide Ifosfamide - Reference Spectrum

20 mg 20 mg 160 mg 10 mg 10 mg 10 mg 100 mg 5 mg 125 mg 15 mg 100 mg 250 mg 10 mg unit 10 mg 175 mg 125 mg 800 mg 1200 mg 20 mg 50 mg 10 mg 600 mg 100 mg 25 mg 25 mg 10 mg 10 mg

EPH1450000 EPY0000447

20 mg 10 mg

EPH1500000 EPY0000448

50 mg 10 mg

EPH1600000 EPY0000449 EPY0000915 EPI0020000 EPB1220000 EPY0000140 EPY0000881 EPI0050000 EPI0060000 EPI0060100

100 mg 10 mg 10 mg 250 mg 1.15 mL 5 mg 0.09 mg 50 mg 50 mg unit

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

277

European Pharmacopoeia
Code Product Unit

EPI0060002 EPI0060004 EPI0060010 EPI0060012 EPI0086000 EPI0090000 EPI0100000 EPY0000893 EPY0001153 EPY0000540 EPY0001205 EPI0150000 EPI0150020 EPY0000788 EPY0000880 EPY0000746 EPI0200000 EPY0000349 EPI0305000 EPI0310000 EPY0000348 EPI0320000 EPI0320300 EPI0320301 EPY0001101 EPI0320330 EPI0320331 EPI0328000 EPY0000839 EPY0001294 EPY0001292

Ifosfamide impurity A 3-[(2-chloroethyl)amino]propyl dihydrogen phosphate Ifosfamide impurity B bis[3-[(2-chloroethyl)amino]propyl]dihydrogen diphosphate Ifosfamide impurity E 3-chloro-N-(2-chloroethyl)propan-1-amine Ifosfamide impurity F (RS)-2-chloro-3-(2-chloroethyl)-1,3,2-oxazaphosphinane 2-oxide Imidazole Imipenem Imipramine hydrochloride Imipramine for system suitability Immunoglobulin for anti-A, anti-B antibodies limit test Immunoglobulin panel for anti-D antibodies test BRP Imperatorin Indapamide Indapamide impurity B 4-chloro-N-(2-methyl-1H-indol-1-yl)-3-sulphamoylbenzamide Indinavir Indinavir sulfate - Reference Spectrum Indinavir for system suitability Indometacin Insulin aspart Insulin (bovine) Insulin (human) Insulin lispro Insulin (porcine) Interferon alfa-2a Interferon alfa-2b Interferon beta-1a Interferon gamma 1b Interferon gamma-1b validation solution Iobenguane sulfate Iobenguane sulphate - Reference Spectrum Iodixanol Iodixanol impurity C 5-[acetyl[3-[[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide Iodixanol impurity E 5-[acetyl[3-[acetyl[3-carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6triiodobenzene-1,3-dicarboxamide Iodixanol impurity H 5-[acetyl[3-[acetyl[3-[[3-[3-[acetyl[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6triiodophenyl]amino]-2-hydroxypropoxy]-2-hydroxypropyl]carbamoyl]-5-[(2,3dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide Iohexol Iohexol impurity A 5-acetamido-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3- dicarboxamide Iohexol impurity J 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3-dicarboxamide Iohexol for peak identification Iopamidol Iopamidol impurity A N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethy]-5-amino-2,4,6-tri-iodoisophthalamide

2x100 mg 20 mg 2x10 mg 10 mg 100 mg 100 mg 50 mg 10 mg 45 mg unit 20 mg 150 mg 5 mg 100 mg unit 20 mg 50 mg 8 mg 7.99 mg 8 mg 5.93 mg 8.61mg 1 mL 200 L 0.5 mL 2x0.5 mL 0.2 mL 25 mg unit 60 mg 10 mg

EPY0001291

10 mg

EPY0001293

10 mg

EPI0320800 EPI0320810 EPI0320820 EPY0000672 EPI0329000 EPI0329010

150 mg 50 mg 125 mg 10 mg 50 mg 10 mg

278

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000406

Iopamidol impurity H 4-chloro-N,N'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-5(2-hydroxypropanoyl)amino)2,6-diiodobenzenz-1,3-dicarboxamide Iopanoic acid Iopentol Iopromide Iopromide impurity A 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methylbenzene-1,3- dicarboxamide Iopromide for system suitability 1 Iopromide for system suitability 2 Iotalamic acid Iotalamic acid impurity A 5-Amino-2,4,6-tri-iodo-N-methylisophthalamic acid Iotrolan Iotrolan for system suitability Ioxaglic acid Ioxaglic acid impurity A 3-amino-5-[(2-hydroxyethyl)carbamoyl]-2,4,6-triiodobenzoic acid Ipratropium bromide Ipratropium impurity A (1R,3r,5S,8r)-3-hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane Ipratropium bromide impurity B (1R,3r,5S,8s)-3-[[(2RS)-3-hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-(1-methylethyl)-8azoniabicyclo[3.2.1]octane Irbesartan Irbesartan impurity A 1-(pentylamino)-N-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]cyclopentanecarboxamide Isoconazole Isoconazole nitrate Isoemetine hydrobromide Isoflurane Isoflurane - Reference Spectrum Isoleucine Isomalt Isomaltooligosaccharide Isoniazid Isoprenaline hydrochloride Isoprenaline sulfate Isopropyl hexadecanoate Isopropyl tetradecanoate Isosorbide dinitrate Isosorbide mononitrate Isosorbide-2-nitrate Isotretinoin Isotretinoin for peak identification Isoxsuprine hydrochloride Isradipine Isradipine impurity D methyl 1-methylethyl 4-(2,1,3-benzoxadiazol-4-yl)-2,6-dimethylpyridine-3,5-dicarboxylate Itraconazole Itraconazole for system suitability Ivermectin Ivy leaf standardised tincture Josamycin

10 mg

EPI0330000 EPY0001297 EPY0001020 EPY0001077 EPY0001021 EPY0001022 EPI0340000 EPA0560000 EPY0000555 EPY0000658 EPY0000141 EPY0000142 EPI0360000 EPY0000276 EPI0361000

100 mg 10 mg 100 mg 0.125 mg 5 mg 5 mg 150 mg 20 mg 100 mg 5 mg 125 mg 20 mg 120 mg 10 mg 10 mg

EPY0001166 EPY0001156 EPI0375000 EPI0380000 EPI0400000 EPY0000858 EPY0000037 EPI0460000 EPI0465000 EPY0000070 EPI0500000 EPI0599990 EPI0600000 EPI0725000 EPI0750000 EPI0775000 EPI0775010 EPI0775020 EPI0800000 New EPY0001218 EPI0900000 EPY0000366 EPY0000367 EPI7000000 EPY0001100 EPI8000010 EPY0000575 EPY0000041

60 mg 10 mg 200 mg 200 mg 25 mg 1.5 mL unit 50 mg 3000 mg 0.9 mg 100 mg 50 mg 500 mg 100 mg 2 mL 300 mg 100 mg 50 mg 60 mg 10 mg 50 mg 125 mg 5 mg 150 mg 15 mg 150 mg 2 mL 150 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

279

European Pharmacopoeia
Code Product Unit

EPY0000042 EPY0001315 EPK0100000 EPK0200000 EPY0000450 EPK0551000 EPY0000246 EPY0000244 EPY0000245 EPK0600000 EPK1000000 EPK2000000 EPK2000010 EPK2000015 EPY0000486 EPY0000626 EPY0000164 EPY0000161 New EPY0001200 EPL0050000 EPL0129000 EPY0000257 EPA1206000 EPL0100000 EPL0130000 EPY0000188 EPY0000425 EPY0000518 EPY0000426 EPY0001030 EPY0001031 EPY0001085 EPY0001032 EPY0000773 EPY0000774 New EPY0001474 EPY0000654 EPY0000487 EPY0000674 EPY0000685 EPL0375000 EPL0376000 EPL0376001 EPY0000047 EPL0380000 EPY0000048

Josamycin propionate Josamycin for peak identification Kanamycin B sulfate Kanamycin monosulfate Ketamine hydrochloride Controlled Substance Ketamine impurity A 1-[(2-chlorophenyl)(methylimino)methyl]cyclopentanol Ketobemidone hydrochloride - Reference Spectrum Ketobemidone impurity B B 1-[4-(3-hydroxyphenyl)-1-methylpiperidin-4-yl]ethanone Ketobemidone impurity C 1-[4-(3-hydroxyphenyl)piperidin-4-yl]propan-1-one Ketoconazole 3-Ketofusidic acid Ketoprofen Ketoprofen impurity A 1-(3-benzoylphenyl)ethanone Ketoprofen impurity C 3-[(1RS)-1-carboxyethyl]benzoic acid Ketorolac trometamol Ketorolac trometamol for peak identification Ketotifen hydrogen fumarate - Reference Spectrum Ketotifen impurity G 4-(1-methylpiperidin-4-ylidene)-4H-benzo(4,5)cyclohepta(1,2-b)thiophen-9,10-dione Kudzuvine root dry extract Labetalol hydrochloride Lactitol monohydrate Lactobionic acid Lactose (anhydrous) Lactose Lactulose Lactulose for system suitability Lamivudine Lamivudine for system suitability 1 Lamivudine for system suitability 2 Lamotrigine Lamotrigine for peak identification Lamotrigine for system suitability Lamotrigine impurity E 2,3-dichlorobenzoic acid Lansoprazole Lansoprazole for peak identification Lauric acid Leflunomide Leflunomide impurity A 4-(trifluoromethyl)aniline Leflunomide for peak identification Letrozole Leucine Leuprorelin Leuprorelin - Reference Spectrum Levamisole hydrochloride for system suitability Levamisole hydrochloride Levamisole - Reference Spectrum

150 mg 25 mg 20 mg 150 mg 10 mg 50 mg unit 5 mg 5 mg 150 mg 10 mg 50 mg 10 mg 5 mg 10 mg 5 mg unit 0.0225 mg 200 mg 80 mg 60 mg 100 mg 100 mg 100 mg 3000 mg 12 mg 150 mg 10 mg 10.3 mg 10 mg 20 mg 10 mg 10 mg 60 mg 1 mg 1500 mg 100 mg 25 mg 1 mg 70 mg 50 mg 1 mg unit 60 mg 50 mg unit

280

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0001253 EPY0001254 EPY0001255 EPY0001256 EPY0001257 EPL0390000 EPL0390008

Levetiracetam Levetiracetam impurity A (2RS)-2-(2-oxopyrrolidin-1-yl)butanoic acid Levetiracetam impurity B (2Z)-2-(2-oxopyrrolidin-1-yl)but-2-enamide Levetiracetam impurity C pyridin-2-ol Levetiracetam impurity D (2R)-2-(2-oxopyrrolidin-1-yl)butanamide ((R)-etiracetam) Levocabastine hydrochloride Levocabastine impurity D 1-[cis-4-cyano-4-(4-fluorophenyl)cyclohexyl]4-phenylpiperidine-4-carboxylic acid Levocarnitine Levocarnitine impurity A (E)-or(Z)-4-(trimethylammonio)but-2-enoate Levodopa Levodropropizine Levodropropizine impurity A (2R)-3-(4-phenylpiperazin-1-yl)propane-1,2-diol(dextrodropropizine) Levodropropizine impurity B 1-phenylpiperazine Levodropropizine impurity C 2,3-epoxypropan-1-ol Levomepromazine hydrochloride Levomepromazine maleate Levonorgestrel Levonorgestrel impurity B 13-ethyl-17-hydroxy-18,19-dinor-17-alpha-pregn-5(10)-en-20-yn-3-one Levonorgestrel for system suitability Levothyroxine for peak identification Levothyroxine sodium Lidocaine Lidocaine hydrochloride Lincomycin chlorhydrate for system suitability Lincomycin hydrochloride Liothyronine sodium Liothyronine for peak identification Lisinopril for system suitability Lisinopril dihydrate Lisinopril impurity F (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-cyclohexylpropyl]amino]hexanoyl]pyrrolidine2-carboxylic acid (cyclohexyl analogue) Lithium clavulanate Lithocholic acid Lobeline hydrochloride Lomustine Loperamide hydrochloride Loperamide hydrochloride for system suitability Loperamide oxide monohydrate Lopinavir for system suitability Loratadine Loratadine for system suitability

110 mg 10 mg 10 mg 10 mg 10 mg 125 mg 20 mg

EPL0399900 EPL0399905 EPL0400000 EPL0420000 EPL0420002 EPY0001033 EPY0001048 EPL0500000 EPL0505000 EPL0551000 New EPY0001379 New EPY0001431 New EPY0001382 EPL0570000 EPL0595000 EPL0600000 New EPY0001393 EPL0650000 EPL0700000 EPY0000860 EPY0001235 EPL0702000 EPY0001234

125 mg 50 mg 100 mg 60 mg 20 mg 50 mg 300 mg 100 mg 50 mg 30 mg 10 mg 10 mg 10 mg 100 mg 50 mg 100 mg 10 mg 250 mg 50 mg 0.0046 mg 2 mg 50 mg 0.01 mg

EPL0720000 EPL0720800 EPY0000112 EPL0745000 EPL0750000 EPY0000322 EPY0000341 New EPY0001505 EPY0000688 EPY0000603

125 mg 60 mg 50 mg 50 mg 50 mg 15 mg 20 mg 10 mg 60 mg 20 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

281

European Pharmacopoeia
Code Product Unit

EPY0000604

Loratadine impurity F ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo[5,6]cyclohepta [1,2-b]pyridin-11-yl]piperidine-1-carboxylate Loratadine impurity H ethyl 4-oxopiperidine-1-carboxylate Lorazepam Controlled Substance Lorazepam for system suitability Controlled Substance Lorazepam impurity D (5RS)-7-chloro-5-(2-chlorophenyl)-4,5-dihydro-1H1,4-benzodiazepine-2,3-dione Losartan potassium Losartan impurity D 2-butyl-4-chloro-1H-imidazole-5-carbaldehyde Losartan for system suitability Lovastatin Lovastatine for peak identification Lufenuron Lufenuron for peak identification Lufenuron impurity G 2,5-dichloro-4-[[[(2,6-difluorophenyl)carbonyl]carbamoyl] amino]phenyl phenyl carbonate Lynestrenol Lynestrenol for peak identification Lysine acetate Lysine hydrochloride Macrogol 30 dipolyhydroxystearate Macrogol 40 sorbitol heptaoleate Macrogol polyvinyl alcohol grafted polymer Magnesium aspartate dihydrate Magnolol Malathion Malathion impurity A diethyl(2RS)-2-[(methoxy)(methylsulfanyl)-S-phosphinothioyl] butane dioate Malathion impurity B diethyl(2RS)-2-(dimethoxy-S-phosphinothioyl)-butanedioate Maleic acid Malic acid - Reference Spectrum Maltitol Mannitol Maprotiline hydrochloride Maprotiline impurity D 3-(9,10-dihydro-9,10-ethanoanthracen-9-yl)-N-methylprop-2-en-1-amine Marbofloxacin Marbofloxacin for peak identification Measles vaccine (live) BRP Mebendazole Mebendazole for system suitability Mebendazole - Reference Spectrum Mebrofenin Meclozine dihydrochloride Meclozine impurity B 4-chlorobenzhydrol Meclozine impurity H 1-(4-chlorobenzhydryl)piperazine

10 mg

EPY0000605 EPL0750500 EPY0000576 EPY0000718

50 mg 100 mg 0.8 mg 10 mg

EPY0001062 EPY0001072 EPY0001076 EPL0790000 EPY0001136 EPY0001284 EPY0001261 EPY0001265

50 mg 6 mg 0.0015 mg 60 mg 20 mg 140 mg 0.4028 mg 15 mg

EPL0800000 EPY0001034 EPY0000397 EPL0900000 EPY0001369 EPY0000745 EPY0001157 EPM0088000 New EPY0001289 EPM0120000 EPM0120005

50 mg 20 mg 60 mg 50 mg 100 mg 20 mg 400 mg 60 mg 20 mg 250 mg 10 mg

EPM0120010 EPM0100000 EPY0000143 EPM0160000 EPM0200000 EPM0206000 EPM0206040 EPY0000819 EPY0000820 EPM0210000 EPM0215000 EPY0000144 EPY0000168 EPY0001086 EPM0220000 EPY0001310 EPY0001311

10 mg 100 mg unit 1200 mg 1200 mg 100 mg 25 mg 10 mg 20 mg 5 uc 20 mg 20 mg unit 120 mg 150 mg 15 mg 15 mg

282

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPM0240000 EPY0001107 EPY0001106 EPM0250000 EPM0250010 EPY0000598 EPM0252600 EPY0001081 EPM0253000 EPM0260100 New EPY0001524 New EPY0001507 EPY0001209 EPY0001080 EPY0001035 EPY0001036 EPY0001037

Medronic acid Medronic acid impurity A Tris(1-methylethoxy)phosphane Medronic acid impurity B Tetrakis(1-methylethyl)methhylenediphosphonate Medroxyprogesterone acetate Medroxyprogesterone acetate for performance test Medroxyprogesterone acetate for system suitability Mefenamic acid Mefenamic acid impurity A 2,3-dimethylaniline Mefloquine hydrochloride Megestrol acetate - Reference Spectrum Megestrol acetate for system suitability Megestrol acetate for peak identification Meglumine Meloxicam Meloxicam impurity A ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide Meloxicam impurity B 5-methylthiazol-2-amine Meloxicam impurity C N-[(2Z)-3,5-dimethylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2benzothiazine-3-carboxamide 1,1-dioxide Meloxicam impurity D N-[(2Z)-3-ethyl-5-methylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2benzothiazine-3-carboxamide 1,1-dioxide Melphalan - Reference Spectrum Melphalan for system suitability Melphalan hydrochloride Menadione Menthol Mepivacaine hydrochloride Mepivacaine impurity B (RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Meprobamate Controlled Substance Mepyramine maleate Mepyramine impurity A N-(4-methoxybenzyl)pyridin-2-amine Mepyramine impurity C pyridin-2-amine Meropenem trihydrate Mesalazine Mesityl oxid Mesna - Reference Spectrum Mesna impurity C 2-(Acetylsulphanyl)ethanesulphonic acid Mesna impurity D 2,2'-(disulphanediyl)bis(ethanesulphonic acid) Meso-rich exametazime Mesterolone Mesterolone impurity A 17-hydroxy-1alpha-methylandrost-4-en-3-one Mestranol Metacresol - Reference Spectrum Metacycline hydrochloride
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

20 mg 60 l 40 l 100 mg 50 mg 10 mg 50 mg 100 mg 100 mg unit 50 mg 25 mg 10 mg 50 mg 5 mg 5 mg 5 mg

EPY0001039

5 mg

New EPY0001513 New EPY0001457 New EPY0001158 EPM0300000 EPM0350000 EPM0370000 EPM0370020 EPM0400000 EPM0500000 EPY0000679 EPY0000680 EPY0001252 EPY0000297 EPY0001040 EPY0000337 EPY0000316 EPY0000317 EPY0000227 EPY0000097 EPY0000096 EPM0600000 EPY0000301 EPM0600500
Edition 2012/2013

unit 10 mg 100 mg 100 mg 150 mg 100 mg 60 mg 100 mg 1000 mg 10 mg 10 mg 110 mg 125 mg 100 mg unit 10 mg 10 mg 0.5 mg 60 mg 30 mg 100 mg unit 50 mg
283

European Pharmacopoeia
Code Product Unit

EPM0600900 EPM0600905 New EPY0001481 EPM0605000 EPY0000770 EPY0000323 EPM0610000 EPM0610030 EPM0620000 EPM0630000 EPM0800000 EPY0000428 EPM0900000 EPY0000754 EPM0950000 EPM0960000 EPM1000000 EPY0000602 EPY0000663

Metamizole sodium Metamizole impurity A 4-formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one Metamizole impurity E 4-N-Demethylanalgin Metformin hydrochloride Methacrylic acid-ethylacrylate copolymer (1:1) - type A Methacrylic acid-ethyl acrylate copolymer (1:1) - type B Methacrylic acid-ethylacrylate copolymer (1:1) - Reference Spectrum Methacrylic acid-ethyl acrylate copolymer (1:1), dispersion 30% - Reference Spectrum Methacrylic acid-methylmethacrylate copolymer (1:1) - Reference Spectrum Methacrylic acid-methylmethacrylate copolymer (1:2) - Reference Spectrum Methadone hydrochloride - Reference Spectrum Methanol - Reference Spectrum Methaqualone - Reference Spectrum Methenamine DL-Methionine Methionine Methotrexate Methotrexate for peak identification Methotrexate impurity C (2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6yl)methyl]methylamino]benzoyl]amino]pentanedioic acid (N-methylfolic acid, methopteridine) Methotrexate impurity D 4-[[(2-amino-4hydroxypteridin-6-yl)methyl]methyl-amino]benzoic acid Methotrexate impurity E 4-[[(2,4-diaminopteridin-6-yl)methyl]methylamino]benzoic acid (4-amino-N10-methylpteroic acid, APA) Methylatropine bromide Methylatropine nitrate Methylcarbidopa Methyl 2-(4-chlorophenoxy)-2-methylpropionate Methyldopa Racemic methyldopa Methyldopa for system suitability Methylene chloride 2-(1-Methylethyl)pentanoic acid Methyl 12-hydroxystearate Methyl nicotinate Methylergometrine maleate Methylergometrine for system suitability Methylnitrosoindoline Methyl parahydroxybenzoate Methylphenidate hydrochloride Controlled Substance Methylphenidate impurity mixture Methylphenobarbital Controlled Substance Methylprednisolone Methylprednisolone acetate Methylprednisolone hydrogen succinate Methylprednisolone hydrogen succinate for performance test 2-Methylpyrazine N-Methylpyrrolidone - Reference Spectrum

100 mg 15 mg 15 mg 50 mg 200 mg 200 mg unit unit unit unit unit unit unit 10 mg 50 mg 50 mg 100 mg 20 mg 10 mg

EPM1000008 EPY0000664

10 mg 10 mg

EPM1300000 EPM1400000 EPM1450000 EPM1470000 EPM1500000 EPY0001374 EPY0001083 EPM1550000 EPM1551000 EPM1556000 EPY0000398 EPY0000776 EPY0000777 EPM1625000 EPM1650000 EPY0001017 EPY0000910 EPM1700000 EPM1750000 EPM1755000 EPM1755200 EPM1755220 New EPY0001376 EPY0000190

100 mg 100 mg 1 mg 0.5 mL 50 mg 5 mg 0.024 mg 2 mL 25 mg 100 mg 25 mg 10 mg 0.53 mg 110 mg 150 mg 40 mg 0.04 mg 500 mg 150 mg 100 mg 125 mg 50 mg 100 mg unit

284

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPM1770180 EPY0000418 EPY0000407 EPM1770200 EPM1800000 EPY0000861 EPM1800900 EPM1800902 EPM1808000 EPM1824990 EPM1825000 EPM1824995 EPM1825010 EPY0000701 EPY0000702 EPY0000171 EPM1830000 EPY0000145 EPM1845000 EPM1850000 EPM1851000 EPY0000069 EPY0000087 EPM1860000 EPY0000202 EPY0000203 EPM1875000 EPY0001041

Methyl ricinoleate Methylrosanilinium chloride Methylrosanilinium chloride for system suitability Methyl stearate Methyltestosterone Methyltestosterone for system suitability Methylthioninium chloride Methylthioninium impurity A 3-(dimethylamino)-7-(methylamino)phenothiazin-5-ylium Metixene hydrochloride Metoclopramid Metoclopramide hydrochloride Metoclopramide impurity A 4-(acetylamino)-5-chloro-N-(2-diethylaminoethyl)-2-methoxy benzamide Metoclopramide impurity E N,N-diethylethane-1,2-diamine Metolazone Metolazone for system suitability Metoprolol succinate - Reference Spectrum Metoprolol tartrate Metoprolol impurity A (2RS)-1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol Metrifonate Metronidazole Metronidazole benzoate Metronidazole benzoate - Reference Spectrum Metronidazole impurity A 2-methyl-4-nitroimidazole Mexiletine hydrochloride Mexiletine impurity C 1,1'-[(3,3',5,5'-tetramethylbiphenyl-4,4'-diyl)bisoxy]dipropan-2-amine Mexiletine impurity D (2RS)-2-(2,6-dimethylphenoxy)propan-1-amine Mianserin hydrochloride Mianserin impurity B (14bRS)-2-methyl-1,2,3,4,10,14b-hexahydrodibenzo[c,f] pyrazino[1,2-a]azepine-8-sulfonic acid Mianserin hydrochloride for system suitability Miconazole Miconazole nitrate Midazolam Controlled Substance Midazolam impurity C acide 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylique Midazolam for system suitability Controlled Substance Milk thistle standardised dry extract Minocycline hydrochloride Minoxidil Minoxidil for system suitability Mirtazapine Mirtazapine for system suitability Misoprostol Misoprostol for system suitability Mitomycin

125 mg 40 mg 10 mg 100 mg 100 mg 10 mg 50 mg 20 mg 75 mg 100 mg 50 mg 25 mg 20 mg 80 mg 10 mg unit 60 mg 10 mg 100 mg 50 mg 50 mg unit 10 mg 100 mg 2 mg 2 mg 100 mg 10 mg

EPY0000862 EPM1880000 EPM1900000 EPM2200000 EPY0000562

1.01 mg 70 mg 100 mg 50 mg 0.08 mg

EPY0000599 EPY0000539 EPM2280000 EPM2300000 New EPY0001432 EPY0000705 EPY0000721 EPY0000490 EPY0001162 EPY0000378

1 mg 120 mg 125 mg 50 mg 10 mg 10 mg 10 mg 60 mg 5 mg 120 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

285

European Pharmacopoeia
Code Product Unit

EPM2305000 EPM2305005 EPY0000635 EPY0000636 EPY0000251 EPY0000821 EPY0000822 EPY0000823 EPM2900000 New EPY0001436 New EPY0001435 New EPY0001433 New EPY0001434 EPY0000028 EPY0000451 EPY0000452 EPY0000830 EPY0000772 EPY0000747 EPY0000703 EPY0000717 EPY0000226 EPY0000222 EPM3600000 EPM3805000 EPM3805500 EPM3806000 EPY0000489 EPY0000519 EPY0000692 EPY0000690 EPY0000691 EPY0000689 EPY0000485 New EPY0001484 EPN0020000 EPN0020020 EPN0020030 EPY0000146 EPY0001215 EPN0025000 EPY0000077 EPY0000120 EPY0000121

Mitoxantrone hydrochloride Mitoxantrone impurity A 1-amino-5,8-dihydroxy-4-[[2-[(2-hydroxyethyl)amino]ethyl]amino]anthracene-9,10-dione Modafinil Modafinil for system suitability Molgramostim Molsidomine Molsidomine impurity B N-Nitrosomorpholine Molsidomine impurity D morpholine-4-carbaldehyde Mometasone furoate Montelukast dicyclohexylamine Montelukast for peak identification Montelukast racemate Montelukast sodium Morantel hydrogen tartrate Morphine hydrochloride (trihydrate) Controlled Substance Morphine sulphate Controlled Substance Morphine for system suitability Controlled Substance Moxidectin Moxidectin for system suitability Moxifloxacin hydrochloride Moxifloxacin for peak identification Moxonidine Moxonidine impurity A 4,6-dichloro-N-(imidazolidin-2-ylidene)-2-methylpyrimidin-5-amine Mumps vaccine (live) BRP Mupirocin - Reference Spectrum Mupirocin calcium - Reference Spectrum Mupirocin lithium Mycophenolate mofetil Mycophenolate mofetil for peak identification Mycoplasma fermentans BRP Mycoplasma hyorhinis BRP Mycoplasma orale BRP Mycoplasma synoviae BRP Myo-inositol Medroxyprogesterone acetate for peak identification Nabumetone Nabumetone impurity D (E)-4-(6-methoxynaphthalen-2-yl)but-3-en-2-one Nabumetone impurity F 6,6'-dimethoxy-2,2'-binaphthalenyl Nadolol Nadolol impurity mixture Nadroparin calcium Naftidrofuryl - Reference Spectrum Naftidrofuryl impurity A 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoic acid Naftidrofuryl impurity B ethyl 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoate

50 mg 5 mg 110 mg 0.1 mg 0.3 mL 5 mg 10 mg 10 mg 100 mg 150 mg 20 mg 20 mg 150 mg 50 mg 25 mg 40 mg 15 mg 70 mg 10 mg 110 mg 10 mg 50 mg 10 mg 5x33 mg unit unit 100 mg 30 mg 10 mg 1 mL 1 mL 1 mL 1 mL 1020 mg 25 mg 60 mg 10 mg 10 mg 100 mg 0.01 mg 250 mg unit 10 mg 25 mg

286

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000331

Naftidrofuryl impurity F 2-[(diethylamino)ethyl 2-[(naphthalen-2-yl)methyl]-3(tetrahydrofuran-2-yl)propanoate Nalidixic acid Naloxone hydrochloride dihydrate Naloxone for peak identification Naltrexone hydrochloride Naltrexone impurity C N-(3-butenyl)-noroxymorphone Nandrolone decanoate Nandrolone decanoate for peak identification Nandrolone decanoate for system suitability Naphazoline hydrochloride Naphazoline nitrate Naphazoline impurity A N-(2-aminoethyl)-2-(naphthalen-1-yl)acetamide (Naphthylacetylethylenediamine) Naproxen Naproxen (racemic) Naproxen impurity L 1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin) Naringin Nateglinide Nateglinide impurity A trans-4-(1-methylethyl)cyclohexanecarboxylic acid Nateglinide impurity B N-[[trans-4-(1-methylethyl)cyclohexyl]carbonyl]-Lphenylalanine (L-phenylalanine isomer) Nateglinide impurity C N-[[cis-4-(1-methylethyl)cyclohexyl]carbonyl]-D-phenylalanine (cis-isomer) Neamine Neohesperidin dihydrochalcone Neohesperidin dihydrochalcone impurity B 7-[[2-O-(6-deoxy--L-mannopyranosyl)--D-glucopyranosyl]oxy]-5-hydroxy-2(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one (neodiosmin) Neomycin sulfate Neomycin sulphate for microbiological assay Neostigmine bromide Neostigmine metilsulfate Netilmicin sulphate Nevirapine (anhydrous) Nevirapine hemihydrate Nevirapine for peak identification Newcastle Disease Vaccine (inacativated) BRP Nicergoline - Reference Spectrum Nicergoline Nicergoline for peak identification Nicergoline for system suitability Nicergoline impurity A [(6aR,9R,10aS)-10a-methoxy-4,7-dimethyl4,6,6a,7,8,9,10,10a-octahydroindol [4,3-fg]quinolin-9-yl]methyl 5-chloropyridine-3-carboxylate Nicergoline impurity D 5-bromopyridine-3-carboxylic acid Niclosamide (anhydrous) Nicotinamide Nicotine - Reference Spectrum
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

10 mg

EPN0050000 EPN0075000 EPY0000695 EPY0000400 EPY0000410 EPY0000542 EPY0000547 EPY0000548 EPN0080000 EPN0100000 EPN0200000 EPN0250000 EPY0000399 EPY0000631 New EPY0001378 New EPY0001437 New EPY0001440 New EPY0001441

100 mg 100 mg 10 mg 50 mg 15 mg 5 mg 10 mg 10 mg 50 mg 10 mg 10 mg 100 mg 10 mg 10 mg 20 mg 200 mg 10 mg 15 mg

New EPY0001442 EPN0300000 EPN0399000 EPN0399004

10 mg 0.5 mg 125 mg 10 mg

EPN0400000 EPN0401000 EPN0500000 EPN0550000 EPN0559000 EPY0000520 New EPY0001499 EPY0000521 EPY0000388 EPY0000287 EPY0001373 EPY0001362 EPY0001352 EPY0000283

50 mg 25 mg 50 mg 50 mg 2x25 mg 30 mg 15 mg 0.058 mg 4 uc unit 50 mg 1 mg 10 mg 10 mg

EPY0001356 EPN0560000 EPN0600000 EPN0590000


Edition 2012/2013

20 mg 50 mg 50 mg unit
287

European Pharmacopoeia
Code Product Unit

EPN0590200 New EPY0001425 EPY0001023 EPN0700000 EPY0001268 EPN0750000 EPN0750010 EPN0750015 EPY0000824 EPY0000825 EPY0000826 EPY0000827 EPY0000836 EPN0800000 EPY0000829 EPY0000894 EPN0845000 EPN0845008 EPY0001237 EPN0850000 EPN0850010

Nicotine ditartrate Nicotine ditartrate dihydrate Nicotine for system suitability Nicotinic acid Nicotinic acid impurity mixture Nifedipine Nifedipine impurity A Dimethyl 2,6-dimethyl-4-(2-nitrophenyl) pyridine-3,5-dicarboxylate Nifedipine impurity B Dimethyl 2,6-dimethyl-4-(2-nitrosophenyl) pyridine-3,5-dicarboxylate Niflumic acid Niflumic acid impurity A 2-chloropyridine-3-carboxylic acid Niflumic acid impurity B 2-hydroxy-N-(3-(trifluoromethyl)phenyl)pyridine-3-carboxamide Niflumic acid impurity E 6-((3-(trifluoromethyl)phenyl)amino)pyridine-3-carboxylic acid Nifuroxazide Nikethamide Nilutamide Nilutamide impurity B 4-nitro-3-(trifluoromethyl)aniline Nimesulide Nimesulide impurity D 4-nitro-2-phenoxyaniline Nimesulide for peak identification Nimodipine Nimodipine impurity A 2-methoxyethyl 1-methylethyl 2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate Nitrazepam Controlled Substance Nitrazepam impurity A 3-amino-6-nitro-4-phenylquinol-2-one Nitrendipine Nitrendipine for peak identification Nitrendipine impurity A ethyl methyl-2,6-dimethyl-4-(3-nitrophenyl) pyridine-3,5-dicarboxylate; (nitrophenylpyridine analogue) Nitric oxide - Reference Spectrum Nitrofural Nitrofural for peak identification Nitrosotriaminopyrimidine Nizatidine Nizatidine for system suitability Nizatidine impurity F (EZ)N1,N1-[thiazole-2,4-diylbis(methylenesulphanediylethylene)] bis(N-methyl-2-nitroethene-1,1-diamine) Nomegestrol acetate Nomegestrol acetate impurity A 6-alpha-methyl-3,20-dioxo-19-norpregn-4-en-17-yl acetate 1-nonadecanol Nonivamide Nonoxinol 9 Noradrenaline tartrate

120 mg 15 mg 1 mg 100 mg 0.12 mg 50 mg 20 mg 20 mg 10 mg 10 mg 10 mg 15 mg 10 mg 1 mL 110 mg 5 mg 100 mg 0.004 mg 10 mg 50 mg 1 mL

EPN0900000 EPN0900010 EPN0905000 New EPY0001456 EPN0905005

100 mg 25 mg 60 mg 10 mg 30 mg

EPN0930000 EPN0950000 EPY0001377 EPN1000000 EPN1090000 New EPY0001278 EPN1090060

unit 100 mg 0.11 mg 50 mg 250 mg 10 mg 10 mg

EPN1080000 EPN1080005 EPY0001314 EPY0000670 EPY0000755 EPN1100000

100 mg 50 mg 400 mg 10 mg 10 mg 200 mg

288

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000681

Noradrenaline impurity D 4[(1R)-2-amino-1-methoxyethyl]benzene-1,2-diol (Noradrenaline methyl ether) Noradrenaline impurity E 2-chloro-1-(3,4-dihydroxyphenyl)ethanone Noradrenaline impurity F N-benzyl-1-phenylmethanamine Norcyclobenzaprine Nordazepam Controlled Substance Dipotassium clorazepate impurity B Norethisterone Norethisterone acetate Norethistherone for system suitability Norfloxacin Norfloxacin for peak identification Norfloxacin impurity A 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid Norfloxacin for system suitability Norgestimate Norgestimate for system suitability Norgestrel Norpseudoephedrine hydrochloride Controlled Substance Nortriptyline for system suitability Nortriptyline hydrochloride Noscapine Nystatin Octoxinol 10 Octyl gallate Octyldodecanol Ofloxacin Ofloxacin impurity A (RS)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de][1,4]benzoxazine-6-carboxylic acid (FPA) Ofloxacin impurity E (RS)-9-fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de] [1,4]benzoxazine-6-carboxylic acid Olanzapine Olanzapine for system sitability Olanzapine impurity A 5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile Oleic acid Oleuropein Olmesartan medoxomil Olmesartan medoxomil for system suitability Olsalazine sodium Olsalazine sodium for performance test Omeprazole Omeprazole magnesium Omeprazole for peak identification Omeprazole impurity D Omeprazole sulphone Ondansetron hydrochloride dihydrate Ondansetron for LC system suitability Ondansetron for TLC system suitability

15 mg

EPY0000682 EPY0000686 EPN1130000 EPN1140000 EPN1200000 EPN1225000 EPY0000522 EPN1230000 EPY0001301 EPN1230010 EPY0001015 EPY0000724 EPY0000725 EPN1250000 EPN1279000 EPY0001296 EPN1280000 EPN1300000 EPN1400000 EPO0100900 EPY0000368 EPO0101000 EPO0120000 EPO0120010

10 mg 10 mg 25 mg 50 mg 100 mg 100 mg 10 mg 50 mg 10 mg 20 mg 8 mg 10 mg 5 mg 30 mg 50 mg 20 mg 10 mg 100 mg 100 mg 300 mg 30 mg 400 mg 50 mg 20 mg

EPO0120050

20 mg

New EPY0001370 New EPY0001380 New EPY0001392 New EPY0001479 EPY0000805 New EPY0001405 New EPY0001424 EPO0146000 EPO0146010 EPO0150000 EPY0001043 EPY0001042 EPO0151000 EPY0000218 EPY0000197 EPY0000196

200 mg 10 mg 5 mg 2000 mg 20 mg 100 mg 10 mg 60 mg 60 mg 50 mg 10 mg 10 mg 10 mg 200 mg 10 mg 30 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

289

European Pharmacopoeia
Code Product Unit

EPY0001345

Ondansetron impurity A (3RS)-3-[(dimethylamino)methyl]-9-methyl-1,2,3,9tetrahydro-4H-carbazol-4-one Ondansetron impurity D 9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one Ondansetron impurity E Imidazole Ondansetron impurity F Ondansetron impurity G (3RS)-3-[(1H-imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro4H-carbazol-4-one (C-demethylondansetron) Orbifloxacin Orbifloxacin impurity mixture Orciprenaline sulfate Orciprenaline for system suitability Orphenadrine citrate Orphenadrine hydrochloride Orphenadrine for peak identification Orphenadrine impurity E (RS)-N,N-dimethyl-2-[(3-methylphenyl)phenylmethoxy]ethanamine (meta-methylbenzyl isomer) Oseltamivir phosphate impurity B free Oseltamivir impurity A (3R,4R,5S)-5-acetamido-4-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid Oseltamivir impurity B ethyl (1R,2R,3S,4R,5S)-4-acetamido-5-amino-2-azido-3(1-ethylpropoxy)cyclohexanecarboxylate Oseltamivir impurity C (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid Oseltamivir impurity H tributylphosphane oxide Osthole Ouabain Oxacillin sodium monohydrate Oxacillin for peak identification Oxaliplatin Oxaliplatin impurity C (OC-6-33)-[(1R,2R)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)kO,kO]dihydroxyplatinum Oxaliplatin impurity D (SP-4-2)-[(1S,2S)-cyclohexane-1,2-diamine-kN,kN'][ethanedioato(2-)kO,kO ]platinum (S,S-enantiomer of oxaliplatin) Oxazepam Controlled Substance Oxazepam for peak identification Oxeladin hydrogen citrate Oxeladin impurity C 2-(diethylamino)ethyl 2-ethyl-2-phenylbutanoate Oxeladin impurity D 2-(2-diethylaminoethoxy)ethyl 2-phenyl-butyrate dihydrogen citrate Oxfendazole for veterinary use Oxfendazole impurity B methyl[5-(phenylsulphonyl)-1H-benzimidazole-2-yl]carbamate Oxfendazole with impurity D Oxitropium bromide Oxitropium bromide impurity B (1R,2R,4S,5S,7s)-7-[[(2S)-3-hydroxy-2-phenylpropanoyl)oxy]-9,9-dimethyl-3-oxa-9azoniatricyclo[3.3.1.02,4]nonane (methylhyoscine)

10 mg

EPY0000195 EPY0001326 EPY0001320 EPY0001346

10 mg 10 mg 10 mg 10 mg

EPY0001125 EPY0001147 EPO0180000 EPY0000895 EPY0000101 EPY0000100 EPY0001181 EPY0000102

200 mg 0.0008 mg 100 mg 5 mg 100 mg 100 mg 0.42 mg 30 mg

EPY0001337 EPY0001338 EPY0001339

300 mg 10 mg 10 mg

EPY0001340 EPY0001341 EPY0001207 EPO0200000 EPY0000638 EPY0000560 EPY0000271 EPY0000273

10 mg 30 mg 20 mg 150 mg 110 mg 10 mg 250 mg 25 mg

EPY0000274

10 mg

EPO0225000 EPY0000543 EPY0000350 EPY0000404 EPY0000390 EPO0225800 EPY0000224 EPY0000225 EPY0000709 EPY0000715

50 mg 0.008 mg 50 mg 10 mg 20 mg 50 mg 10 mg 10 mg 50 mg 15 mg

290

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000713

Oxitropium bromide impurity D (1R,2R,4S,5S,7s,9r)-9-ethyl-9-methyl-7-[(2-phenylprop-2-enoyl)oxy]-3-oxa-9azoniatricyclo[3.3.1.02,4]nonane (apo-N-ethylhyoscine) Oxolinic acid Oxolinic acid impurity A 8-hydroxy-1,3-dioxolo[4,5-g]quinoline-7-carboxylic acid Oxolinic acid impurity B ethyl 5-ethyl-8-oxo-5,8-dihydro-1,3-dioxolo[4,5-g]quinoline-7-carboxylate Oxprenolol hydrochloride Oxibendazole Oxybuprocaine hydrochloride Oxybutynin hydrochloride Oxybutynin impurity A 4-(diethylamino)but-2-ynyl(RS)-2-(cyclohex-3-enyl)-2-cyclohexyl-2-hydroxyacetate Oxycodone hydrochloride Controlled Substance Oxycodone impurity D 7,8-didehydro-4,5 alpha-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6-one (14-hydroxycodeinone) Oxymetazoline hydrochloride Oxymetazoline impurity A N-(2-aminoethyl)-2-[4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetamide Oxytetracycline Oxytetracycline hydrochloride Oxytocin Oxytocin/Desmopressin validation mixture about 0.1 mg oxytocin + 0.1 mg desmopressin per vial Paclitaxel Paclitaxel impurity C N-debenzoyl-N-hexanoylpaclitaxel Paclitaxel natural for peak identification Paclitaxel semi-synthetic for peak identification Paclitaxel semi-synthetic for system suitability Palmitic acid Pamidronate disodium pentahydrate Pancrease powder (amylse and lipase) BRP Pancreas powder (protease) BRP Pancuronium bromide Vecuronium impurity B Pancuronium bromide for system suitability Pantoprazole sodium sesquihydrate Pantoprazole for system suitability Papaverine hydrochloride Paracetamol Paraffin (hard) Paraffin (liquid) - Reference Spectrum Paraffin (White soft) Paraffin (Yellow soft) Parnaparin sodium Paroxetine hydrochloride (anhydrous) Paroxetine hydrochloride hemihydrate Paroxetine impurity A (3S,4R)-3-[[1,3-benzodioxol-5-yloxy]methyl]-4-phenylpiperidine (desfluoroparoxetine) Paroxetine hydrochloride (anhydrous) impurity C (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-1-benzyl-4-(4-fluorophenyl)piperidine (N-benzylparoxetine)

10 mg

EPO0240000 EPO0240005 EPO0240010 EPO0250000 EPO0260000 EPO0270000 EPO0288000 EPO0288005 EPY0000492 EPY0000453

50 mg 20 mg 20 mg 50 mg 100 mg 150 mg 150 mg 10 mg 100 mg 50 mg

EPO0290000 EPY0001044 EPO0400000 EPO0500000 EPO0700000 EPO0770000 EPY0000698 EPY0000699 EPY0000700 EPY0000719 EPY0000739 EPP0090000 EPY0000524 EPP0100000 EPP0200000 EPP0250000 EPY0000577 EPY0000835 EPY0001001 EPP0270000 EPP0300000 EPY0000780 EPY0000058 EPY0000913 EPY0000912 EPP0305000 EPY0000578 EPY0000281 EPY0000233 EPY0000579

80 mg 10 mg 100 mg 20 mg 1 mg 0.2 mg 40 mg 5 mg 10 mg 10 mg 1 mg 100 mg 10 mg 2000 mg 2000 mg 20 mg 20 mg 20 mg 0.5055 mg 25 mg 50 mg 10 mg unit 10 mg 10 mg 250 mg 100 mg 200 mg 15 mg 10 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

291

European Pharmacopoeia
Code Product Unit

EPY0000256

Paroxetine impurity D (3R,4S)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine ((+)-transparoxetine) Paroxetine impurity E (3RS,4RS)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4fluorophenyl)piperidine (cis-paroxetine) Paroxetine hydrochloride (anhydrous) impurity H [(3S,4R)-1-benzyl-4-(4-fluorophenyl)piperidin-3-yl]methanol Paroxetine for system suitability Pefloxacin mesilate dihydrate Pefloxacin impurity B 1-ethyl-6-chloro-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (chlorinated homologue of pefloxacin) Pefloxacin impurity C 1-ethyl-6-fluoro-5-(4-methylpiperazin-1yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (isopefloxacin) Penbutolol sulfate Penbutolol impurity A (2S)-1-[2-(cyclopent-1-enyl)phenoxy]-3-[(1,1-dimethylethyl)amino]propan-2-ol Penicillamine Penicillamine disulphide 3,3-(disulphanediyl)bis[(2)-2-amino-3-methylbutanoic]acid Pentamidine diisetionate Pentazocine - Reference Spectrum Pentazocine hydrochloride - Reference Spectrum Pentazocine lactate - Reference Spectrum Pentetate sodium calcium Pentobarbital Controlled Substance Pentoxifylline Pentoxyverine hydrogen citrate - Reference Spectrum Pentoxyverine impurity A 1-phenylcyclopentanecarboxylic acid Pentoxyverine impurity B 2-(diethylamino)ethyl-1-phenylcyclopentanecarboxylate (caramiphen) Pepsin powder Pergolide mesilate Perindopril impurity A (2S,3aS,7aS)-octahydro-1Hindole-2-carboxylic acid Perindopril for stereochemical purity Perindopril tert-butylamine Perindopril for peak identification Perphenazine Perphenazine for system suitability Pertussis toxin BRP Pethidine hydrochloride - Reference Spectrum Pethidine impurity A 1-methyl-4-phenylpiperidine (MPP) Phenazone Phenazone impurity A 5-methyl-2-phenyl-2,4-dihydro-3-pyrazol-3-one Pheniramine impurity A 2-Benzylpyridine Pheniramine maleate Phenobarbital Controlled Substance Phenobarbital impurity A (5RS)-5-ethyl-2,6-diimino-5-phenyltetrahydropyrimidin-4(1H)-one Phenobarbital impurity B (5RS)-5-ethyl-6-imino-5-phenyldihydropyrimidine-2,4(1H,3H)-dione
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg

EPY0000580 EPY0000581 EPY0000630 EPP0309000 EPP0309020

5 mg 10 mg 5 mg 200 mg 10 mg

EPP0309030

0.01 mg

EPP0307000 EPP0307005 EPP0310000 EPP0320000 EPP0405000 EPP0405500 EPP0405510 EPY0000417 EPY0001051 EPP0500000 EPP0510000 EPY0000076 EPY0000098 EPY0000099 EPP0525000 EPY0000010 EPY0000237 EPY0000207 EPY0000238 EPY0000771 EPP0550000 EPY0001045 EPY0000021 EPP0600000 EPP0600002 EPP0800000 EPY0001138 New EPY0001428 EPP0850000 EPP0900000 EPY0001350 EPY0001351

100 mg 20 mg 100 mg 100 mg 30 mg unit unit unit 100 mg 500 mg 100 mg unit 10 mg 10 mg 2000 mg 150 mg 10 mg 40 mg 40 mg 5 mg 100 mg 5 mg 2x0.05 mg unit 20 mg 20 mg 20 mg 20 mg 250 mg 200 mg 15 mg 15 mg

292

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPP0950000 EPP1000000 EPP1100000 EPP1109000 EPY0001127 EPY0001251 EPP1150000 EPP1200000 EPY0000147 EPP1240000 EPP1250000 EPY0000683 EPY0000229 EPP1255100 EPP1260000 EPP1290000 EPY0001167 EPP1300000 EPY0000493 EPY0000761 EPY0000798 EPY0000766 EPP1500000 EPP1600000 EPP1605000 EPP1609000 EPP1609010 EPP1645000 EPP1645005 EPY0000124 EPY0000123 EPP1650000 EPP1700000 EPY0000106 EPY0000525 EPY0000401 EPP1750000 EPP1800000 New EPY0001519 New EPY0001520 New EPY0001476 EPY0000061 EPP1890000 EPP1900000 EPP2000000 EPP2100000 EPY0000288 EPY0000038

Phenoxyethanol Phenoxymethylpenicillin Phenoxymethylpenicillin potassium Phentolamine mesilate - Reference Spectrum Phentolamine mesilate Phentolamine mesilate for system suitability Phenylalanine Phenylbutazone Phenylbutazone impurity B (4-butyl-4-hydroxy-1,2-diphenyl-3,5)pyrazolidinedione Phenylephrine Phenylephrine hydrochloride Phenylephrine hydrochloride for peak identification Phenylmercuric acetate - Reference Spectrum Phenylmercuric borate - Reference Spectrum Phenylpropanolamine hydrochloride (Norephedrin hydrochloride) Drug Precursor Phenytoin Phenytoin for system suitability Phenytoin sodium Phloroglucinol (anhydrous) Pholcodine Controlled Substance Pholcodine for peak identification Controlled Substance Phthalic acid benzene-1,2-dicarboxylic acid Phthalylsulfathiazole Physostigmine salicylate Physostigmine sulfate Phytomenadione trans-Epoxyphytomenadione Picotamide monohydrate Picotamide impurity A 4-methoxybenzene-1,3-dicarboxylic acid Pidolate impurity B (2S)-2-[[[(2S)-5-oxopyrrolidin-2-yl]carbonyl]amino]pentanedioic acid Pidolic acid Pilocarpine hydrochloride Pilocarpine nitrate Pilocarpine nitrate for system suitability Pimobendan Pimobendan for system suitability Pimozide Pindolol Pioglitazone for system suitability Pioglitazone hydrochloride Pipemidic acid trihydrate Pipemidic acid trihydrate - Reference Spectrum Piperacillin Piperazine adipate Piperazine citrate Piperazine hydrate Piracetam Pirenzepine dihydrochloride monohydrate

2 mL 250 mg 250 mg unit 10 mg 10 mg 60 mg 100 mg 20 mg 60 mg 50 mg 2 mg unit unit 50 mg 100 mg 20 mg 250 mg 210 mg 10 mg 10 mg 20 mg 100 mg 100 mg 100 mg 150 mg 10 mg 125 mg 25 mg 60 mg 125 mg 50 mg 50 mg 20 mg 10 mg 0.1 mg 150 mg 100 mg 15 mg 120 mg 15 mg unit 100 mg 250 mg 250 mg 250 mg 120 mg 250 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

293

European Pharmacopoeia
Code Product Unit

EPP2120000 New EPY0001458 EPP2120002 EPP2130000 EPP2150000 EPP2152000 EPP2152015

Piretanide Piretanide for system suitability Piretanide impurity A 4-phenoxy-3(1H-pyrrol-1-yl)-5-sulphamoylbenzoic acid Piroxicam Pivampicillin Pivmecillinam hydrochloride Pivmecillinam impurity C methylene 2,2-dimethylpropanoate (2RS,4S)-2-[[[(hexahydo-1H-azepin-1-yl) methylene]amino]methyl]-5,5-dimethylthiazolidin-4-carboxylate Plastic additive 01 (2RS)-2-ethylhexyl)benzene-1,2-dicarboxylate Plastic additive 03 N,N'-ethylenedialcanamide Plastic additive 04 Epoxidised soya oil Plastic additive 05 Epoxidised linseed oil Plastic additive 08 Ethylene bis [3,3-bis[3-(1,1-dimethylethyl)-4-hydroxyphenyl]butanoate] Plastic additive 09 pentaerythrityl tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] Plastic additive 10 4,4',4''-(2,4,6-trimethylbenzene-1,3,5-triyltrismethylene)-trio[2,6-bis(1,1-dimethylethyl)phenol] Plastic additive 11 Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate Plastic additive 12 Tris(2,4-di-1,1-dimethylethylphenyl)phosphite R Plastic additive 13 1,3,5-tris(3,5-di-1,1-dimethylethyl-4-hydroxybenzyl)-1H,3H,5H-1,3,5-triazine-2,4,6-trione Plastic additive 14 2,2'-Di(octadecycloxy)5,5'-spirobi(1,3,2,-dioxaphosphorinane) R Plastic additive 15 Dioctadecyl disulphide Plastic additive 16 Didodecyl 3,3'-thiodipropionate R Plastic additive 17 Dioctadecyl 3,3'-thiodipropionate R Plastic additive 18 Plastic additive 20 Oleamide R Plastic additive 21 Erucamide R Plastic additive 22 Copolymer of dimethyl butanedioate and 1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol Synonyms: copolymer of dimethyl succinate and (4-hydroxy-2,2,6,6-tetramethylpiperidin-1yl)ethanol Plastic additive 23 di(isooctyl)2,2'-[(dioctylstannylene)bis(thio)]diacetate containing about 27% of (tri(isooctyl)2,2',2''-[monooctylstannylidyne)tris(thio)]triacetate Tin-content of 15.4% Poliomyelitis vaccine (inactivated) BRP Poliomyelitis vaccine (oral) BRP Poloxamer 124 Poloxamer 188 Poloxamer 237 Poloxamer 338 Poloxamer 407 Polyacrylate - Reference Spectrum Polymyxin B sulfate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg 10 mg 20 mg 100 mg 50 mg 100 mg 10 mg

EPP2155001 EPP2155003 EPE0800000 EPP2155005 EPP2155008 EPP2155009 EPP2155010 EPP2155011 EPP2155012 EPP2155013 EPP2155014 EPP2155015 EPP2155016 EPP2155017 EPP2155018 EPO0140000 EPE1260000 EPP2155022

2 mL 100 mg 500 mg 500 mg 500 mg 250 mg 250 mg 500 mg 250 mg 250 mg 250 mg 500 mg 250 mg 250 mg 100 mg 100 mg 100 mg 100 mg

EPP2155023

200 mg

EPP2160000 EPP2161000 EPP2163920 EPP2164009 EPP2164020 EPP2164021 EPP2164030 EPP2170000 EPP2400000


294

5x0.5 mL 5x1 mL 30 mg 100 mg 100 mg 100 mg 100 mg unit 25 mg


Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000355 EPY0000289 EPY0000290 EPY0000291 EPY0000007 EPY0000792 EPP2600000 EPP2649610 EPY0001168 EPY0000315 EPP2650000 EPY0001275 EPP2660000 EPY0000466 EPY0001266 EPY0001187 EPY0001267 EPY0000215 EPY0000223

Polymyxin B sulfate for microbiological assay Polysorbate 20 - Reference Spectrum Polysorbate 40 - Reference Spectrum Polysorbate 60 - Reference Spectrum Polysorbate 80 - Reference Spectrum Poly(vinyl acetate) dispersion 30% Poly(vinyl chloride) Potassium clavulanate - Reference Spectrum Potassium clavulanate impurity G Potassium hydrogen aspartate hemihydrate Potassium sorbate Potassium sucrose octasulfate Povidone Povidone (iodinated) Pramipexole dihydrochloride monohydrate Pramipexole for system suitability Pramipexole impurity D (6R)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine Pravastatin sodium - Reference Spectrum Pravastatin impurity A (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoic acid (6'-epipravastatin) Pravastatin 1,1,3,3-tetramethylbutylamine Prazepam Controlled Substance Praziquantel Praziquantel impurity A (11bRS)-2-benzoyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one Prazosin hydrochloride Prednicarbate Prednicarbate for system suitability Prednicarbate impurity F 1,2-dihydroprednicarbate Prednisolone Prednisolone for peak identification Prednisolone for system suitability Prednisolone acetate Prednisolone acetate for peak identification Prednisolone hexanoate Prednisolone pivalate Prednisolone sodium phosphate Prednisone Pregnenolone isobutyrate Prekallikrein activator in albumin BRP Prilocaine Prilocaine hydrochloride Prilocaine impurity B 2-methylbenzenamine hydrochloride Prilocaine impurity E (RS)-N-(methylphenyl)-2-(propylamino)propanamide Primaquine diphosphate Primidone Primidone for peak identification

25 mg unit unit unit unit 1500 mg 100 mg unit 5 mg 50 mg 100 mg 100 mg 50 mg 10 mg 5 mg 15 mg 5 mg unit 0.1 mg

EPY0000204 EPP2669000 EPP2670000 EPP2675000 EPP2680000 EPP2698000 New EPY0001443 EPP2698060 EPP2700000 EPY0001359 EPY0001355 EPP2800000 EPY0000582 EPP2804000 EPP2805000 EPP2810000 EPP2900000 EPP2920000 EPY0000263 EPP2939000 EPP2939060 New EPY0001408 EPP2939025 EPP2940000 EPP2950000 EPY0000369

30 mg 50 mg 150 mg 10 mg 50 mg 100 mg 10 mg 10 mg 150 mg 10 mg 10 mg 120 mg 10 mg 10 mg 100 mg 100 mg 100 mg 150 mg 3x1 mL 150 mg 100 mg 80 mg 25 mg 500 mg 150 mg 5 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

295

European Pharmacopoeia
Code Product Unit

EPP3000000 EPP3050000 EPP3090000 EPP3100000 EPP3200000 EPP3300000 EPY0000148 EPY0000179 EPY0000181 EPY0000182 EPP3350000 EPP3390000 EPP3400000 EPY0000769 EPY0000797 EPP3490000 EPY0000455 EPY0000456

Probenecid Procainamide hydrochloride Procaine benzylpenicillin Procaine hydrochloride Prochlorperazine maleate Progesterone Progesterone impurity C (20R)-20-hydroxypregn-4-en-3-one Proguanil hydrochloride - Reference Spectrum Proguanil impurity C 1,5-bis(4-chlorophenyl)biguanide Proguanil impurity D 1,5-bis(1-methylethyl)biguanide Proline Promazine hydrochloride Promethazine hydrochloride Promethazine impurity D (2RS)-N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine S-oxide Promethazine for peak identification Propacetamol hydrochloride - Reference Spectrum Propafenone hydrochloride Propafenone impurity B 2E)-1-[2-[(2RS)-2-hydroxy-3-(propylamino)propoxy] phenyl]-3-phenylprop-2-en-1-one Propanol - Reference Spectrum Propofol Propofol for peak identification Propofol impurity J 2,6-bis (1-methylethyl)-1,4-benzoquinone Propranolol hydrochloride Propranolol hydrochloride for performance test Propylene glycol dilaurate Propylene glycol monolaurate Propyl gallate Propyl parahydroxybenzoate Propylthiouracil Propyphenazone Protirelin D-His Protirelin Proxyphylline Pseudoephedrine hydrochloride Drug Precursor Pseudoisoeugenyl 2-methylbutyrate for peak identification Purpureaglycoside A Purpureaglycoside B Pyrantel embonate Pyrantel impurity A 1-methyl-2-[(Z)-2-(thiophen-2-yl)ethenyl]-1,4,5,6-tetrahydropyrimidine Pyrazinamide Pyridostigmine bromide Pyridostigmine impurity A pyridin-3-yl-dimethylcarbamate Pyridostigmine bromide impurity B 3-hydroxy-1-methylpyridinium Pyridoxine hydrochloride

100 mg 100 mg 250 mg 100 mg 100 mg 50 mg 10 mg unit 10 mg 10 mg 60 mg 100 mg 50 mg 10 mg 10 mg unit 10 mg 10 mg

EPY0000278 EPY0000016 EPY0000017 EPY0000018 EPP3500000 EPP3600000 EPY0000318 EPY0000319 EPP3640000 EPP3650000 EPP3700000 EPP3750000 EPP3760000 EPP3760020 EPP3800000 EPP3850000 EPY0000387 EPP3900000 EPP4000000 EPY0000402 EPY0000403 EPP4050000 EPP4099900 EPP4099910 New EPY0001486 EPP4100000

unit 290 mg 0.1 mL 20 mg 30 mg 20 mg 100 mg 100 mg 50 mg 150 mg 100 mg 200 mg 2x5.03 mg 0.1 mg 100 mg 50 mg 100 mg 25 mg 25 mg 10 mg 20 mg 30 mg 50 mg 20 mg 10 mg 100 mg

296

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0001226 EPP4200000 EPY0000659 EPY0001009 EPQ0100000 EPQ0200000 EPR0100000 EPY0000896 EPY0000897 EPY0000898 EPY0000902 EPY0001134 EPY0001135 EPR0145000 EPR0145005

Pyridoxine impurity A 6-methyl-1,3-dihydrofuro[3,4-c]pyridin-7-ol Pyrimethamine Pyrrolidone Quercetin dihydrate Quinidine sulfate Quinine sulfate Rabies vaccine (inactivated) for veterinary use BRP Racecadotril Racecadotril impurity A Ethanethioic acid Racecadotril impurity G benzyl[[(2RS)-2-benzyl-3-sulfanylpropanoyl]amino]acetate Racecadotril for peak identification Raloxifene hydrochloride Raloxifene hydrochloride for peak identification Ramipril Ramipril impurity A (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(methoxycarbonyl)-3-phenylpropyl]amino] propanoly]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril methylester) Ramipril impurity B (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-[(methylethoxy)carbonyl]-3-phenylpropyl] amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril isopropyl ester) Ramipril impurity C (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(ethoxycarbonyl)-3-cyclohexylpropyl]amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (hexahydroramipril) Ramipril impurity D ethyl(2S)-2-[(3S,5aS,8aS,9aS)-3-methyl-1,4-dioxodecahydro -1H-cyclopenta[e]pyrrolo[1,2a]pyrazin-2-yl]-4-phenylbutanoate (ramipril diketopiperazine) Ranitidine hydrochloride Ranitidine impurity J 1,1'-N-[methylenebis(sulphanediylethylene)]bis (N'-methyl-2-nitroethene-1,1-diamine) Ranitidine for system suitability Repaglinide Repaglinide for system suitability Repaglinide impurity E 2-ethoxy-4-[2-[[(1R)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amino]2-oxoethyl]benzoic acid Reserpine Residual solvents solution class I Resorcinol Retinol acetate Retinol ester Reviparin sodium Ribavirin Riboflavin (Vitamine B2) Riboflavin for peak identification Riboflavine sodium phosphate Ribonucleic acid Rifabutin Rifabutin impurity A 1-(2-methylpropyl)piperidin-4-one Rifampicin Rifampicin quinone
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

5 mg 250 mg 20 mg 20 mg 300 mg 300 mg 3x86 mg 110 mg 1 mL 10 mg 5 mg 110 mg 10 mg 20 mg 10 mg

EPR0145010

10 mg

EPR0145015

10 mg

EPR0145020

10 mg

EPR0150000 EPY0000416

100 mg 0.00025 mg

EPY0000411 EPY0000457 EPY0000458 EPY0000459 EPR0200000 EPR0250000 EPY0000767 EPR0300000 EPR0290000 EPR0500500 EPY0000377 EPR0600000 EPY0000757 EPR0630000 EPY0000662 EPY0000149 EPY0000184 EPR0700000 EPR0800000
Edition 2012/2013

20 mg 20 mg 6 mg 10 mg 100 mg 1.4 mL 20 mg 1000 mg 100 mg 250 mg 2x150 mg 100 mg 0.12 mg 250 mg 100 mg 150 mg 20 mg 100 mg 100 mg
297

European Pharmacopoeia
Code Product Unit

EPR0900000 EPR0950000 EPR1000000 EPY0001074 EPY0001075 EPY0000250 EPY0000187 EPR1000600 EPY0000370 EPY0001276

Rifamycin B Rifamycin S Rifamycin sodium Rifaximin Rifaximin for system suitability Rilmenidine dihydrogenophosphate - Reference Spectrum Rilmenidine for system suitability Risperidone Risperidone for system suitability Risperidone impurity K 3-[2-[4-(1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4Hpyrido[1,2a]pyrimidin-4-one (desfluoro risperidone) Ritonavir Ritonavir for peak identification Rivastigmine for system suitability Rizatriptan benzoate Rizatriptan for system suitability RK 13 cells cell lines (kidney,rabbit) titration of live measles, mumps and rubella vaccines Rocuronium bromide - Reference Spectrum Rocuronium for peak identification Ropivacaine hydrochloride monohydrate Ropivacaine impurity G (+)-(2R)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide ((R)-ropivacaine) Rosmarinic acid Roxithromycin Roxithromycin for system suitability Rubella vaccine (live) BRP Ruscogenins Rutoside trihydrate Saccharin Saccharin Sodium Salbutamol Salbutamol impurity B (1RS)-2-[(1,1-dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol Salbutamol impurity D 5-[(1RS)-2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl]-2hydroxybenzaldehyde Salbutamol impurity F 1,1'[oxybis[methylene(4-hydroxy-1,3-phenylene)]]bis [2-[(1,1-dimethylethyl)amino]ethanol] Salbutamol impurity G 2-[benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-hydroxymethyl) phenyl]ethanone Salbutamol impurity I (1RS)-2-[(1,1-dimethylethyl)amino]-1-[3-(hydroxymethyl)-4-benzyloxyphenyl] ethanol Salbutamol impurity J 2-[(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone (salbutamone) Salbutamol sulfate Salbutamol sulfate for system suitability Salicin Salicylic acid Salicylic acid impurity B 4-hydroxyisophthalic acid Salmeterol xinafoate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

50 mg 50 mg 300mg 160 mg 10 mg unit 30 mg 50 mg 20 mg 0.015 mg

EPY0000714 EPY0000706 New EPY0001485 New EPY0001302 New EPY0001303 EPR1300000

80 mg 10 mg 1.0114 mg 200 mg 15 mg 2x1 mL

EPY0000594 EPY0000527 EPY0000742 EPY0000743 EPY0000786 EPR1500000 EPY0000220 EPR2000000 EPY0000494 EPY0000105 EPS0040000 EPS0050000 EPS0100000 EPY0000030 EPY0000071

unit 10 mg 10 mg 5 mg 40 mg 125 mg 5 mg 5x18 mg 10 mg 100 mg 30 mg 50 mg 50 mg 5 mg 5 mg

EPY0000031

5 mg

EPY0000034

5 mg

EPY0000032 EPY0001186 EPS0150000 EPY0001288 EPY0000669 EPS0200000 EPY0000405 EPY0000422


298

0.006 mg 0.00045 mg 50 mg 10 mg 50 mg 100 mg 10 mg 50 mg


Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000423 EPY0001052 EPY0001049 EPY0001056 New EPY0001483 EPY0000814 EPY0000815 EPS0360000 EPS0360090 EPS0400000 EPS0450000 EPS0460000 EPY0000828 EPY0000866 EPY0000867 EPY0001285 EPY0000371 EPY0001046 EPS0500000 EPS0600000 EPS0650000 EPY0001066 EPS0660000 EPY0000014 EPS0695000 EPY0000300 EPY0000039 EPS0700000 EPS0710000 EPS0750000 EPY0001300 EPS0760000 New EPY0001410 EPS0781000 EPS0780000 New EPY0001468 EPY0000620 EPY0000808 EPY0000809 EPS0785000 EPY0001104 EPY0000210 EPY0000268 EPS0800000 EPS0808000 EPS0808060 EPS0900000 EPS0930000 EPS0945000 EPS0947000

Salmeterol xinafoate for system suitability Santonin Saquinavir mesilate Saquinavir for system suitability Saw palmetto extract Selamectin Selamectin for system suitability Selegiline hydrochloride (RS)-Selegiline hydrochloride Senna extract Serine Sertaconazole nitrate Sertraline hydrochloride Sertraline for peak identification Sertraline for system suitability Sertraline impurity E Sestamibi labelling kit Sevoflurane Silicone elastomer Silicone oil Simvastatin Simvastatin for peak identification Sisomicin sulfate Sodium alendronate Sodium amidotrizoate Sodium aminosalicylate dihydrate - Reference Spectrum Sodium ascorbate Sodium calcium edetate Sodium cetostearyl sulfate Sodium cromoglicate Sodium cromoglicate for system suitability Sodium cyclamate Sodium fusidate Sodium hyaluronate - Reference Spectrum Sodium hyaluronate BRP Sodium iodohippurate Sodium laurilsulfate Sodium phenylbutyrate Sodium phenylbutyrate impurity C 4-cyclohexylbutanoic acid Sodium picosulfate Picosulfate for system suitability Sodium polystyrene sulphonate - Reference Spectrum Sodium propionate - Reference Spectrum Sodium salicylate Sodium stearyl fumarate Sodium stearyl maleate Sodium taurocholate BRP Sodium valproate Somatostatin Somatropin

25 mg 20 mg 70 mg 0.3033 mg 8g 100 mg 5 mg 50 mg 25 mg 50 mg 50 mg 125 mg 200 mg 5.4 mg 6.18 mg 15 mg 22 mg 1 mL 2000 mg 1 mL 100 mg 10 mg 50 mg 150 mg 125 mg unit 50 mg 100 mg 100 mg 10 mg 20 mg 100 mg 10 mg unit 300 mg 15 mg 40 mg 5 mg 10 mg 100 mg 0.5 mg unit unit 100 mg 50 mg 10 mg 10000 mg 150 mg 2.45 mg 55 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

299

European Pharmacopoeia
Code Product Unit

EPY0000711 EPS0950000 EPY0000385 EPS1000000 EPY0000114 EPY0000115 EPY0001011 EPY0000597 EPY0000549 EPY0000655 EPY0001126 EPS1100000 EPY0000381 EPY0000332 EPS1200000 EPY0001295 EPY0000185 EPY0001050 EPY0001091 EPS1250000 EPS1250010 New EPY0001420 EPS1300000 EPY0000408 EPY0000421 EPS1340000 EPS1350000 EPY0000868 EPS1400000 EPS1500000 EPY0001324 EPY0001344 EPY0001342

Somatropin/desamidosomatropin resolution mixture Sorbic acid 1,4-Sorbitan Sorbitol Sotalol hydrochloride Sotalol impurity B N-[4-[[(1-methylethyl)amino]acetyl]phenyl]methanesulphonamide Spanish sage oil for peak identification Spectinomycin hydrochloride Spectinomycin for system suitability Spectinomycin sulphate tetrahydrate Spike lavender oil Spiramycin Spirapril hydrochloride monohydrate Spirapril for system suitability Spironolactone Spironolactone for system suitability Squalane St.John's wort standardised dry extract Standardised artichoke leaf dry extract Stanozolol Stanozolol impurity A (5,17)-17-hydroxy-17-methylandrostan-3-one Stanozolol impurity B Starch BRP Stavudine Stavudine for system suitability Stearic acid Plastic additive 19 Stearyl alcohol Streptokinase for system suitability Streptomycin sulphate Succinylsulfathiazole Sucralfate Sucralose Sucralose impurity B 1,6-dichloro-1,6-dideoxy--D-fructofuranosyl 6-chloro-6-deoxy--D-glucopyranoside (1,6,6-trichloro-1,6,6-trideoxysucrose) Sucrose Sufentanil - Reference Spectrum Sufentanil citrate - Reference Spectrum Sulbactam sodium Sulbactam Sulbactam for peak identification Sulfacetamide sodium Sulfadiazine Sulfadiazine impurity A 2,6-dimethylaniline Sulfadiazine for identification of impurity F Sulfadimidine Sulfadoxine Sulfafurazole Sulfaguanidine
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

33 mg 10 mg 50 mg 1200 mg 25 mg 20 mg 250 mg 100 mg 20 mg 10 mg 400 l 200 mg 60 mg 15 mg 150 mg 2.055 mg 0.25 mL 500 mg 60 mg 50 mg 10 mg 10 mg 50000 mg 100 mg 10 mg 100 mg 250 mg 30 l 100 mg 100 mg 10 mg 550 mg 0.5 mg

EPS1600000 EPS1608100 EPS1609000 EPY0000529 EPY0000528 EPY0000550 EPS1700000 EPS1800000 New EPY0001469 New EPY0001480 EPS1900000 EPS1950000 EPS1975000 EPS1975600
300

100 mg unit unit 10 mg 150 mg 20 mg 50 mg 100 mg 20 mg 15 mg 100 mg 50 mg 100 mg 60 mg


Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPS2000000 EPS2050000 EPS2100000 EPY0000412 EPY0000413 EPS2150000 EPS2151000 EPS2159100 EPS2155000 EPS2155010 EPS2158000 EPS2159000 EPY0001238 EPS2159010 EPS2159015 EPS2160000 EPS2180000 EPS2190000 EPS2191000 EPS2192000 EPY0000530 EPY0000531 EPY0000532 EPY0000022 EPY0000026 EPY0000027 EPS2200000 EPS2400000 EPS2400004 EPS2400006 EPS5000001 EPS5000002 New EPY0001417 EPT0010000 EPT0014000 EPT0015000 EPY0000650 EPY0000653 EPY0000651 EPY0000652 EPY0001102 EPY0001047 EPY0000648

Sulfamerazine Sulfamethizole Sulfamethoxazole Sulfamethoxazole impurity A N-(4-(5-methyl)-isoxazol-3-ylsulphamoyl)phenylacetamide Sulfamethoxazole impurity F 4-amino-N-(3-methylisoxazol-5-yl)benznesulphonamide Sulfamethoxypyridazine Sulfanilamide Sulfapyridine Sulfasalazine Sulfasalazine derivative for resolution 2-hydroxy-5-[[4-[[(6-methylpyridin-2-yl)amino]-sulfonyl]phenyl]azo]benzoic acid Sulfathiazole Sulfinpyrazone Sulfinpyrazone for system suitability Sulfinpyrazone impurity A 1,2-diphenyl-4-(2-phenylsulphonylethyl)pyrazolidine-3,5-dione Sulfinpyrazone impurity B 1,2-diphenyl-4-(2-phenylthioethyl)pyrazolidine-3,5-dione Sulfisomidine Sulindac Sulpiride Sulpiride impurity A [(2RS)-1-ethylpyrrolidin-2-yl]methanamine Sulpiride impurity B methyl 2-methoxy-5-sulphamoylbenzoate Sultamicillin Sultamicillin tosilate Sultamicillin for peak identification Sumatriptan succinate Sumatriptan impurity mixture Sumatriptan for system suitability Suxamethonium chloride Suxibuzone Suxibuzone impurity B (4-butyl-3,5-dioxo-1,2-diphenylpyrazolidin-4-yl)methyl ethyl butanedioate Suxibuzone impurity C 4-butyl-4-(hydroxymethyl)-1,2-diphenyl-1,2-dihydro-4H-pyrazole-3,5-dione Swine erysipelas bacteria, serotyp 1 (for vaccines-vet.use) BRP Swine erysipelas bacteria, serotyp 2 (for vaccines-vet.use) BRP Tadalafil Talampicillin hydrochloride Tamoxifen citrate Tamoxifen citrate for performance test Tamsulosin hydrochloride Tamsulosin racemate Tamsulosin impurity D 2-methoxy-5[(2R)-2-[[2-(2-methyoxyphenoxy)ethyl]amino]propyl]benzenesulfonamide Tamsulosin impurity H (2R)-N-[2-(2-ethoxyphenoxy)ethyl]-1-(4-methoxyphenyl)propan-2-amine Teicoplanin Teicoplanin for identification Telmisartan

100 mg 100 mg 50 mg 5 mg 5 mg 50 mg 100 mg 20 mg 2x250 mg 20 mg 100 mg 30 mg 0.5 mg 20 mg 20 mg 50 mg 50 mg 100 mg 20 mg 20 mg 10 mg 200 mg 10 mg 50 mg 3 mg 2 mg 1000 mg 50 mg 10 mg 10 mg 1 mg 1 mg 200 mg 50 mg 80 mg 30 mg 10 mg 10 mg 10 mg 10 mg 52 mg 40 mg 30 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

301

European Pharmacopoeia
Code Product Unit

EPY0000649 EPY0001003 EPT0040000 EPY0000344

Telmisartan for peak identification Telmisartan for system suitability Temazepam Controlled Substance Temazepam impurity C (3RS)-7-chloro-1-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-3-yl acetate Controlled Substance Temazepam impurity D (3RS)-7-chloro-3-methoxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one Controlled Substance Temazepam impurity F (5RS)-7-chloro-1-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione Temazepam impurity G (5RS)-7-chloro-1,4-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione Tenoxicam Tenoxicam impurity mixture Terazosin hydrochloride dihydrate Terazosin for system suitability Terazosin impurity A 2-chloro-6,7-dimethoxyquinazolin-4-amine Terazosin impurity E 2,2`-(piperazine-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine) Terazosin impurity L 1-(furan-2-ylcarbonyl)piperazine Terazosin impurity N 1-[[(2RS)-tetrahydrofuran-2-yl]carbonyl]piperazine Terbinafine hydrochloride Terbinafine for system suitability Terbutaline sulfate Terbutaline impurity C 1-(3,5-dihydroxyphenyl)-2-[(1,1- dimethylethyl)amino]-ethanone Terconazole Terfenadine Terfenadine impurity A 1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butan-1-one (ketone) Testosterone Testosterone caproate Testosterone decanoate Testosterone decanoate for system suitability Testosterone enantate Testosterone enantate for peak identification Testosterone enantate for system suitability Testosterone enantate impurity H delta-5-testosterone-3,17-dienantate Testosterone for impurity D identification Testosterone for system suitability Testosterone isocaproate Testosterone isocaproate for system suitability Testosterone propionate Testosterone propionate for system suitability Tetanus vaccine (adsorbed) BRP Tetra-O-acetyl-mannose triflate Tetracaine hydrochloride Tetracaine for system suitability Tetracosactide

10 mg 0.26 mg 50 mg 5 mg

EPY0000345

5 mg

EPY0000346 EPY0000347 EPT0040800 EPY0001114 EPY0000621 EPY0000666 EPY0000622 EPY0000665 EPY0000623 EPY0000624 EPY0000535 EPY0001143 EPT0050000 EPT0050015 EPT0060000 EPT0071000 EPT0080000

5 mg 5 mg 100 mg 0.0042 mg 40 mg 0.5 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 100 mg 15 mg 250 mg 100 mg 20 mg

EPT0100000 EPT0210000 EPT0240000 EPY0000696 EPT0250000 EPY0001312 EPY0001317 EPY0001313 EPY0000342 EPY0000343 EPT0260000 EPY0000716 EPT0300000 New EPY0001409 EPT0400000 EPY0001087 EPT0500000 EPY0001002 EPT0550000

30 mg 50 mg 50 mg 0.4 mg 100 mg 10 mg 20 mg 10 mg 20 mg 20 mg 50 mg 5 mg 60 mg 5 mg 30 mg 60 mg 100 mg 2 mg 2x0.366mg

302

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPT0600000 EPY0001165 EPY0000015 EPY0000008 EPY0000460 EPY0000723 EPT0700000 EPT0800000 EPY0000294 EPY0000336 EPY0000372 EPY0000373 EPY0000467 EPY0000059

Tetracycline hydrochloride Tetrandrine Tetrazepam - Reference Spectrum Tetrazepam impurity C 7-chloro-5-cyclohexyl-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one Tetryzoline hydrochloride Thebaine Controlled Substance Theobromine Theophylline Theophylline - Reference Spectrum Thiamazole Thiamazol impurity A 2,2-dimethoxy-N-methylethanamine Thiamazol impurity C 1-methyl-2-(methylsulphanyl)-1H-imidazole Thiamine hydrochloride Thiamine impurity E 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl) 4-methyl-4-thiazolidine-2-thione Thiamine nitrate - Reference Spectrum Thiamphenicol Thioctic acid Thioctic acid for system suitability Thioctic acid containing impurity B Thiomersal Thiopental Thiopental for system suitability Thioridazine Thioridazine hydrochloride Thioridazine for system suitability Thioxanthene Thioxanthone Threonine Thymol Tiabendazole Tiamulin for peak identification Tiamulin hydrogen fumarate Tiamulin - Reference Spectrum Tianeptine sodium - Reference Spectrum Tianeptine for system suitability Tianeptine impurity A ethyl 7-bromoheptanoate Tiapride hydrochloride Tiapride N-oxide Tiaprofenic acid Tiaprofenic acid impurity C (2RS)-2-(5-benzoylthiophen-3-yl)propanoic acid Tibolone - Reference Spectrum Tibolone for system suitability Ticarcillin monosodium Ticarcillin impurity A (2S,5R,6R)-3,3-dimethyl-7-oxo-6-[[(thiophen-3-yl)acetyl]-amino]-4-thia-1azabicyclo[3.2.0]heptane-2-carboxylic acid (decarboxyticarcillin) Ticlopidine hydrochloride
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

100 mg 20 mg unit 20 mg 10 mg 10 mg 100 mg 100 mg unit 125 mg 15 mg 20 mg 10 mg 10 mg

EPY0000060 EPT1100000 EPY0000546 EPY0000592 EPY0000545 EPY0000109 EPT1200000 New EPY0001478 EPY0000704 EPT1300000 EPY0000541 EPT1305100 EPT1305000 EPT1340000 EPT1350000 EPT1410000 EPY0000414 EPY0000333 EPY0000379 EPY0000151 EPY0000152 EPY0000153 EPT1405000 EPT1405050 EPT1410900 EPT1410910 EPY0000748 EPY0000668 EPY0000465 EPT1420010

unit 125 mg 110 mg 10 mg 30 mg 30 mg 500 mg 10 mg 10 mg 100 mg 0.21 mg 20 mg 10 mg 50 mg 50 mg 50 mg 10 mg 500 mg unit unit 30 mg 20 mg 60 mg 20 mg 50 mg 20 mg unit 10 mg 250 mg 50 mg

EPT1423000
Edition 2012/2013

50 mg
303

European Pharmacopoeia
Code Product Unit

EPT1423025 EPY0000325 EPY0001270 EPT1450000 EPY0000644 EPT1470000 EPY0000899 EPT1471000 EPT1490000 EPY0000292 EPY0000282 EPY0001188 EPY0001216 EPY0001179 EPY0001189 EPT1500000 EPY0001210 EPY0000383 EPY0000384 EPT1550000 EPT1600000 EPT1610000 EPT1700000 EPY0000154 EPT1707000 EPY0001123 EPY0000461 EPY0000462 EPY0001366 EPY0000155 EPY0000156 EPY0000157 EPY0000072 EPY0000065 EPY0000066

Ticlopidine impurity F 6-(2-chlorobenzyl)4,5,6,7-tetrahydrothieno [3,2-c]pyridine Tilidine hydrochloride hemihydrate - Reference Spectrum Timolol for system suitability Timolol maleate (R)-timolol Tinidazole Tinidazole impurity A 2-methyl-5-nitro-1H-imidazole Tinidazole impurity B 1-(2-ethylsulphonylethyl)-2-methyl-4-nitroimidazole Tinzaparin sodium Tioconazole - Reference Spectrum Tioconazole for system suitability Tiotropium bromide monohydrate Tiotropium impurity F dithiophen-2-ylmethanone Tiotropium impurity mixture Tiotropium for system suitability Tobramycin Tobramycin for identification All-rac-alpha-tocopherol for peak identification All-rac-alpha-tocopheryl acetate for peak identification alpha-Tocopherol alpha-Tocopheryl acetate RRR-alpha-Tocopheryl hydrogen succinate Tolbutamide Tolfenamic acid Tolnaftate Tolnaftate for system suitability Torasemide anhydrous Torasemide for system suitability Torasemide impurity E ethyl [[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl]carbamate Tramadol hydrochloride Tramadol impurity A (1RS,2SR)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Tramadol impurity E (2RS)-2-[(dimethylamino)methyl]cyclohexanone Tramazoline hydrochloride monohydrate Tramazoline impurity A N-(naphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine Tramazoline impurity B mixture of: 1-acetyl-2-[(5,6,7,8-tetrahydronaphthalen-1-yl)amino]-4,5-dihydro-1H-imidazole and N-(4,5-dihydro-1H-imidazol-2-yl)-N-(5,6,7,8-tetrahydronaphthalen-1-yl)acetamide Trandolapril Trandolapril impurity C (2S,3aR,7aS)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1(ethoxycarbonyl)propyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid (hexahydrotrandolapril) Trandolapril impurity D ethyl (2S)-2-[(3S,5aS,9aR,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]4-phenylbutanoate (trandolapril diketopiperazine) Tranexamic acid Trapidil

10 mg unit 5.045 mg 100 mg 20 mg 100 mg 10 mg 20 mg 250 mg unit 50 mg 10 mg 10 mg 0.08 mg 10 mg 51 mg 250 mg 15 mg 30 mg 500 mg 500 mg 150 mg 100 mg 100 mg 60 mg 10 mg 10 mg 5 mg 0.0006 mg 75 mg 15 mg 15 mg 20 mg 10 mg 10 mg

EPY0000501 EPY0000495

10 mg 10 mg

EPY0000496

10 mg

EPT1810000 EPT1820000

50 mg 50 mg

304

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPT1820002 EPT1820004 EPY0001172 EPT1850000 EPT1899000 EPG0400010 EPT1899990 EPT1900000 New EPY0001459 EPT1950000 EPY0000050 EPY0000837 EPY0000870 EPT1975000 EPY0000165 EPY0000166 EPY0001055 EPY0000279 EPY0000799 EPT1977990 EPT1977995 EPT1978000 EPY0000111 EPT1985000 EPT1986000 EPT2000000 EPT2005000 EPT2005010 EPY0000720 EPY0000108 EPY0000068 EPT2009000 EPY0001260 EPY0001319 EPY0000092 EPY0000093 EPT2100000 EPT2200000 EPY0000684 EPT2200010 EPT2450000 EPT2500000 EPY0000759 EPT2500100 EPT2501200

Trapidil impurity A 5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-ol Trapidil impurity B 1,2,4-triazol-3-amine Trehalose dihydrate Tretinoin 3,4,6-Tri-O-acetyl-D-glucal - Reference Spectrum Triacetin - Reference Spectrum Triamcinolone Triamcinolone acetonide Triamcinolone acetonide for system suitability Triamcinolone hexacetonide Triamcinolone impurity C 9-fluoro-11-16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione Triamterene Triamterene impurity B 2,7-diamino-6-phenylpteridin-4-ol Triazolam Controlled Substance Tribenoside Tribenoside impurity A 3,5,6-tri-O-benzyl-1,2-O-(1-methylethylidene)--D-glucofuranose Tributyl acetylcitrate Tri-n-butyl phosphate Tributyl acetylcitrate for peak identification Tricaprin Tricaproin Tricaprylin Trichloroacetic acid - Reference Spectrum Trichlorotrifluoroethane Triethyl citrate - Reference Spectrum Trifluoperazine hydrochloride Triflusal Triflusal impurity B 2-hydroxy-4-(trifluoromethyl)benzoic acid Triglycerol diisostearate Trihexyphenidyl hydrochloride Trihexyphenidyl impurity A 1-phenyl-3-(piperidin-1-yl)propan-1-one Trilaurin Trimebutine for system suitability Trimebutine maleate Trimetazidine dihydrochloride - Reference Spectrum Trimetazidine for system suitability Trimethadione Trimethoprim Trimethoprim for system suitability Trimethoprim impurity B (2,4-diaminopyrimidin-5-yl)(3,4,5- trimethoxyphenyl)methanone Trimethyltetradecylammonium bromide Trimipramine maleate Trimipramine for peak identification Trimyristin Tristearin

20 mg 20 mg 250 mg 50 mg unit unit 150 mg 150 mg 10 mg 100 mg 10 mg 10 mg 0.5 mg 10 mg 150 mg 60 mg 1 mL 300 L 25 mg 150 mg 40 mg 225 mg unit 2.5 mL unit 100 mg 50 mg 25 mg 200 mg 100 mg 20 mg 1250 mg 1.017 mg 10 mg unit 50 mg 250 mg 50 mg 0.00075 mg 15 mg 200 mg 100 mg 0.51 mg 500 mg 100 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

305

European Pharmacopoeia
Code Product Unit

EPT2545000 EPY0001184 EPY0001183 EPT2550000 EPT2580000 EPY0001316 EPY0001247 EPY0001248 EPY0000616 EPY0000618 EPT2580300 EPY0000429 EPY0000432 EPY0000431 EPY0000430 EPY0000497 EPT2600000 EPT2610000 EPT2800000 EPT2880000 EPT2880100 EPY0000498 EPT2880200 EPT2900000 EPT3000000 EPU0020000 EPU0020001 EPU0020008

Trolamine Trolamine impurity A Ethanolamine Trolamine impurity B Diethanolamine Trometamol Tropicamide Tropicamide for peak identification Tropicamide impurity C (2RS)-3-hydroxy-2-phenylpropanoic acid (tropic acid) Tropicamide impurity D Phenylacetic acid Drug Precursor Tropisetron hydrochloride Tropisetron impurity B 1H-indole-3-carboxylic acid Tropine Trospium chloride Trospium impurity A Hydroxydiphenylacetic acid (benzilic acid) Trospium impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl hydroxydiphenylacetate Trospium impurity C (1R,3r,5S)-3-hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium] Troxerutin Trypsin BRP Tryptophan Tubocurarine chloride Tylosin Tylosin D Tylosin phosphate for peak identification Tylosin tartrate - Reference Spectrum Tyrosine Tyrothricin Ubidecarenone Ubidecarenone for system suitability Ubidecarenone impurity D 5,6-dimethoxy-3-methyl-2-[(all-E)-3,7,11,15,19,23,27,31,35nonamethylhexatriaconta-2,6,10,14,18,22,26,30,34-nonaenyl] benzene-1,4-dione Uracil arabinoside Urea Ursodeoxycholic acid Ursodeoxycholic acid for system suitability Ursolic acid Valaciclovir for system suitability Valaciclovir hydrochloride (anhydrous) Valaciclovir impurity D 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-ethyl-L-valinate Valaciclovir impurity E 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-[(benzyloxy)carbonyl]-L-valinate Valaciclovir impurity F para-toluenesulfonate 2-hydroxyethyl L-valinate Valaciclovir impurity G N,N-dimethylpyridin-4-amine Valerian standardised dry extract Valine
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

2250 mg 250 mg 1 mL 100 mg 50 mg 10 mg 10 mg 10 mg 40 mg 10 mg 50 mg 10 mg 20 mg 20 mg 5 mg 30 mg 100 mg 100 mg 100 mg 150 mg 5 mg 10 mg unit 50 mg 20 mg 50 mg 1 mg 5 mg

EPU0100000 EPU0600000 EPU0800000 EPY0001163 New EPY0001523 EPY0001225 EPY0000834 EPY0001096 EPY0001097 EPY0001098 EPY0001099 EPY0000583 EPV0030000
306

60 mg 100 mg 100 mg 1.26 mg 25 mg 10 mg 100 mg 10 mg 10 mg 12 mg 10 mg 400 mg 50 mg


Edition 2012/2013

European Pharmacopoeia
Code Product Unit

EPY0000584 EPY0000533 EPY0000585 EPY0000586

Valnemulin hydrochloride Valnemulin hydrogen tartrate Valnemulin for peak identification Valnemulin impurity E (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro3a,9-propano-3aH-cyclopenta[8]annulen-8-yl 2-hydroxyacetate (pleuromulin) Valproic acid Valproic acid for system suitability Valsartan Valsartan for peak identification Valsartan for system suitability Vancomycin hydrochloride Vanillin Varicella vaccine (live) Vecuronium bromide Vecuronium for peak identification Vedaprofen Vedaprofen impurity mixture Venlafaxine hydrochloride Venlafaxine for system suitability Verapamil hydrochloride Verapamil impurity I (2RS)-2-(3,4-dimethoxyphenyl)-2-[2-[[2-(3,4)dimethoxyphenyl)ethyl](methyl)amino]ethyl]3-methylbutanenitrile Verapamil impurity M 5,5'-[[2-(3,4)dimethoxyphenyl)ethyl]imino]bis[2-(3,4-dimethoxyphenyl)2-(1-methylethyl)pentanenitrile Verbenalin VERO cells Vigabatrin Vigabatrin impurity A (5RS)-5-ethenylpyrrolidin-2-one Vigabatrin impurity B (2E)-2-(2-aminoethyl)but-2-enoic acid Vigabatrin impurity D 4-aminobutanoic acid Vigabatrin impurity E 2-[(2RS)-2-aminobut-3-enyl]propanedioic acid Viscosimeter calibration liquids Vinblastine sulphate Vinblastine sulfate - Reference Spectrum Vincristine sulphate Vincristine sulfate - Reference Spectrum Vindesine sulphate Vindesine sulfate - Reference Spectrum Vinorelbine tartrate Vinorelbine impurity B 4-O-deacetylvinorelbine Vinpocetine Vinpocetine impurity A (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1Hindolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate) Vinpocetine impurity B (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1ij][1,5]naphthyridine-12-carboxylate (apovincamine)

10 mg 120 mg 20 mg 10 mg

EPV0033000 New EPY0001422 EPY0001132 EPY0001131 EPY0001145 EPV0045000 EPV0050000 EPY0001198 EPY0000561 EPY0000625 EPY0001093 EPY0001118 EPY0000587 EPY0000588 EPV0100000 EPV0100018

100 mg 10 mg 10 mg 10 mg 0.202 mg 100 mg 100 mg 420 mg 10 mg 10 mg 5 mg 0.006 mg 50 mg 1 mg 100 mg 5 mg

EPV0100026

10 mg

EPY0000661 EPV0180000 New EPY0001400 New EPY0001401 New EPY0001402 New EPY0001404 New EPY0001403 EPV0200000 EPV0300000 EPV0305000 EPV0400000 EPV0405000 EPV0500000 EPV0500010 EPY0000463 EPY0000464 EPY0000589 EPY0000590

11 mg 2x1 mL 10 mg 25 mg 20 mg 50 mg 10 mg 250 mL 5 mg unit 4.98 mg unit 5.11 mg unit 50 mg 7 mg 10 mg 10 mg

EPY0000591

10 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

307

European Pharmacopoeia
Code Product Unit

EPY0000790

Vinpocetine impurity C ethyl(13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (methoxyvinpocetine) Vinpocetine impurity D (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine) Vinyl acetate Voriconazole Voriconazole impurity B (2RS,3SR)-2-(2,4-difluorophenyl)-3-pyrimidin-4-yl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol Voriconazole impurity D (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (epi-voriconazole) Voriconazole impurity E [(1R,4S)-7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl]methanesulfonic acid ((+-)camphorsulfonic acid) Warfarin sodium Warfarin sodium clathrate Xylazine hydrochloride Xylazine impurity C 2,6-dimethylphenyl isothiocyanate Xylazine impurity E N-(2,6-dimethylphenyl)-S-methyldithiourea Xylazine impurity mixture Xylitol Xylometazoline Hydrochloride Xylometazoline impurity A N-(2-aminoethyl)-2-(4-1,1-dimethylethyl-2,6-dimethylphenyl)acetamide Xylose Yohimbine hydrochloride Zidovudine Zidovudine impurity A 1-[(2R,5S)-5-hydroxymethyl-2,5-dihydro-2-furyl]-5-methylpyrimidine-2,4(1H,3H)-dione Zidovudine impurity B 1-(3-chloro-2,3-dideoxy--D-ribofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione Zinc acexamate Zinc acexamate impurity A 6-[[6-(acetylamino)hexanoyl]amino] hexanoic acid Ziprasidone for system suitability 1 Ziprasidone for system suitability 2 Ziprasidone hydrochloride monohydrate Zolpidem tartrate Controlled Substance Zolpidem impurity A N,N'-dimethyl-2-[7-methyl-2-(4-methylphenyl)imidazol [1,2-a]pyridin-3-yl] acetamide Zopiclone Controlled Substance Zopiclone oxide Zuclopenthixol decanoate - Reference Spectrum Zuclopenthixol for system suitability Zuclopenthixol impurity B 2-chloro-9H-thioxanthen-9-one

10 mg

EPY0000760

10 mg

EPY0000793 New EPY0001395 New EPY0001396 New EPY0001398

200 mg 120 mg 10 mg 10 mg

New EPY0001397

50 mg

EPW0100000 EPY0000778 EPX0075000 EPY0000158 EPY0000159 EPY0001224 EPX0080000 EPX0100000 EPX0101000 EPX0200000 EPY0000656 EPZ1900000 EPZ1902000 EPZ1904000 EPZ2000000 EPZ2000010 EPY0001272 EPY0001241 EPY0001286 EPZ2500000 EPZ2500010

10 mg 10 mg 125 mg 50 mg 15 mg 0.02 mg 500 mg 100 mg 10 mg 100 mg 20 mg 60 mg 10 mg 10 mg 50 mg 50 mg 10 mg 0.465 mg 100 mg 200 mg 10 mg

EPZ3000000 EPZ3001000 EPY0000062 EPY0000534 EPY0000083

60 mg 20 mg unit 0.1 mg 10 mg

308

Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.

Edition 2012/2013

ATCC microbiology products

ATCC microbiology products


As a scientist you know the importance of using the best materials to support your quality control programme. As Europes only officially authorized distributor of ATCC cultures, LGC Standards can supply all ATCC organisms specified in the pharmacopoeia. ATCC maintains the highest standards for its biological materials, employing stringent quality control procedures to produce cultures which are well characterized and have low passage numbers. Long-term subculturing of biological materials can have adverse effects on the culture population, including genetic drift, unwanted selection, contamination, and varied cell responses. ATCC quality control cultures sold by LGC Standards are never subcultured or transferred in any way from ATCCs strains and our European stock-holding means orders are usually filled within 3 - 5 working days. So whether it is quality control strains, genomic DNA, media or growth supplements, antibiotics for selection, or a huge selection of organisms, take the time and guesswork out of ordering your microbiology supplies with authentic, high-quality ATCC materials - exclusively from LGC Standards.

European Pharmacopoeia, 7th Edition (2011-2013), general chapters


Code Product Unit

EP 2.6.1 - Sterility
ATCC-16404 ATCC-6633 ATCC-10231 ATCC-11437 ATCC-19404 ATCC-9027 ATCC-6538 Aspergillus brasiliensis Bacillus subtilis Candida albicans Clostridium sporogenes Clostridium sporogenes Pseudomonas aeruginosa Staphylococcus aureus ss. aureus amp. amp. amp. amp. amp. amp. amp.

EP 2.6.2 - Mycobacteria
ATCC-25177 Mycobacterium tuberculosis amp.

EP 2.6.7 - Mycoplasmas
ATCC-23206 ATCC-19989 ATCC-19610 ATCC-17981 ATCC-29052 ATCC-23714 ATCC-15531 ATCC-25204 Acholeplasma laidlawii (Sabin) Edward and Freundt deposited as Mycoplasma laidlawii Mycoplasma fermentans Mycoplasma gallisepticum Mycoplasma hyorhinis Switzer Mycoplasma hyorhinis Mycoplasma orale Mycoplasma pneumoniae Mycoplasma synoviae amp. amp. amp. amp. amp. amp. amp. amp.

EP 2.6.12 - Microbiological examination of non-sterile products


ATCC-16404 ATCC-6633 ATCC-10231 ATCC-9027 ATCC-6538 Aspergillus brasiliensis Bacillus subtilis Candida albicans Pseudomonas aeruginosa Staphylococcus aureus ss. aureus amp. amp. amp. amp. amp.

EP 2.6.13 - Microbiological examination of non-sterile products


ATCC-10231 ATCC-11437 ATCC-19404 ATCC-8739 ATCC-9027 ATCC-14028 ATCC-6538 Candida albicans Clostridium sporogenes Clostridium sporogenes Escherichia coli Pseudomonas aeruginosa Salmonella enterica subsp. enterica serovar Typhimurium Staphylococcus aureus ss. aureus amp. amp. amp. amp. amp. amp. amp.

EP 2.6.27 - Microbiological control of cellular products


ATCC-16404 ATCC-6633
Edition 2012/2013

Aspergillus niger Bacillus subtilis


Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

amp. amp.
309

European Pharmacopoeia, 7th Edition (2011-2013), general chapters


Code Product Unit

ATCC-10231 ATCC-19404 ATCC-11437 ATCC-9027 ATCC-6538

Candida albicans Clostridium sporogenes Clostridium sporogenes Pseudomonas aeruginosa Staphylococcus aureus ss. aureus

amp. amp. amp. amp. amp.

EP 2.7.2 - Microbiological assay of antibiotics


ATCC-14884 ATCC-11774 ATCC-6633 ATCC-4617 ATCC-10541 ATCC-9637 ATCC-10536 ATCC-10031 ATCC-9341 ATCC-10240 ATCC-607 ATCC-9763 ATCC-9144 ATCC-6538P ATCC-12228 Bacillus pumilus Bacillus subtilis Bacillus subtilis Bordetella bronchiseptica Enterococcus hirae (as Streptococcus faecalis) Escherichia coli Escherichia coli Klebsiella pneumoniae ss. pneumoniae Kocuria rhizophila Micrococcus luteus Mycobacterium smegmatis Saccharomyces cerevisiae Staphylococcus aureus ss. aureus Staphylococcus aureus subsp. aureus Staphylococcus epidermidis amp. amp. amp. amp. amp. amp. amp. amp. amp. amp. amp. amp. amp. amp. amp.

EP 5.1.1 - Methods of preparation of sterile products


ATCC-19146 Brevendimonas diminuta (as Pseudomonas diminuta) amp.

EP 5.1.2 - Biological indicators of sterilisation


ATCC-27142** ATCC-7953** ATCC-9372** Bacillus pumilus Bacillus stearothermophilus Bacillus atrophaeus amp. amp. amp.

EP 5.1.3 - Efficacy of antimicrobial preservation


ATCC-16404 ATCC-10231 ATCC-8739 ATCC-9027 ATCC-6538 Aspergillus brasiliensis Candida albicans Escherichia coli Pseudomonas aeruginosa Staphylococcus aureus ss. aureus ** = Alternative strain All care has been taken in compiling catalogue numbers, however users should consult the Pharmacopoeia directly to confirm the testing requirements and recommended organisms before ordering or undertaking the testing procedures as described in the Pharmacopoeia. amp. amp. amp. amp. amp.

310

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

Certified Liquids for Viscosity Measurements in the European Pharmacopoeia

Certified Liquids for Viscosity Measurements in the European Pharmacopoeia


Newtonian liquids with a certified viscosity are supplied by Van Swinden Laboratorium BV and are distributed by LGC Standards. Liquids are available with kinematic viscosities up to 48000 mm2s-1 and certified at temperatures between 15C and 140C. Viscosities are certified in mm2s-1 (kinematic viscosity, v) or in mPa.s (dynamic viscosity,) 1 mPa.s = 1 cps (centipoise) 1 mm2.s-1= 1 cst (centistoke) Standard liquids are available from stock, in 250 ml packs and certified at 20C to following viscosities: v = 0,6 ; 1,0 ; 2,2; 4,9 ; 1; 20 ; 31 ; 56 ; 67 ; 85 ; 100 ; 132 ; 167 ; 217 ; 262; 340 ; 423 ; 537 ; 644 ; 783 ; 1000 ; 1260 ; 1800 ; 3650 ; 5075 ; 10175 ; 18400 ; 46500 = 0,4 ; 1,0 ; 1,8; 4,0 ; 8,9 ; 17,0 ; 26,0 ; 48,0 ; 58,0 ; 74,0 ; 87,0 ; 116,0 ; 146,0 ; 191,0 ; 230,0 ; 300,0 ; 375,0 ; 474,0 ; 572,0 ; 700,0 ; 862,0 ; 1085 ; 1560 ; 3175 ; 4430 ; 8935 ; 16300 ; 41300 All viscosities are calibrated relative to the viscosity of pure water. Stated values are nominal values, certified values will not deviate more than 10% from the nominal value. The uncertainty of the certified viscosities is at least 0.3% at the lowest viscosity, increasing up to 0.5% at 48000 mm2.s-1.

Shelf life
Standards up to 500 mPa.s are mineral oil based, and have a shelf life of 12 months from date of certification. Above 500 mPa.s Polyisobutylene is used, these materials have a shorter shelf life, and should be ordered as needed. Liquids can be prepared and certified to any viscosity between 0.6 mm2.s-1 and 80,000 mm2.s-1. The price depends on the viscosity required, the degree of precision between nominal viscosity required and certified viscosity achieved, and temperature of certification. Additional charges are applied for extra certification temperatures and for certification of dynamic viscosity. Please ask for a quotation. Liquids supplied by customers may be certified for viscosity, charges vary: please ask for a quotation.

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

311

International Commission on Pharmaceutical Enzymes

International Commission on Pharmaceutical Enzymes


The Commission on Pharmaceutical Enzymes was formed in 1960, with a remit to establish quantitative methods and an exact definition of enzyme activity for pharmacologically significant enzymes. One consequence of the work of FIP Federation International Pharmaceutique has been the production and certification of reference substances for both enzymes and substrates. More recently the work of the Commission has been reflected in those monographs of the European Pharmacopoeia which call for enzyme standards. The FIP products marked (EP) in this list are those which are required in certain EP monographs.

Enzymes
Code Product Unit

FIP1 FIP2(EP) FIP3 FIP4 FIP5 FIP6(EP) FIP7 FIP8(EP) FIP9 FIP10 FIP11(EP) FIP12(EP) FIP13(EP) FIP14(EP)

Fungal Amylase Amylase (pancreatic) Fungal Protease Bromelain Endocellulase Chymotrypsin Fungal Lipase Lipase (pancreatic) Lysozyme hydrochloride Papain Pepsin Protease (pancreatic) Trypsin Hyaluronidase

2g 2g 2g 250 mg 1g 100 mg 500 mg 2g 250 mg 2g 2g 2g 100 mg 50 mg

Substrates
FIP15(EP) FIP16 FIP17(EP) FIP18(EP) FIP19 FIP20 FIP21(EP) FIP22(EP) Enterokinase Micrococcus Luteus sp. Starch (EP) Casein Haemoglobin Hydroxyethylcellulose Sodium Taurocholate Sodium hyaluronate 200 mg 1g 50 g 100 g 10 g 100 g 10 g 300 mg

312

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

European Pharmacopoeia Reagents

European Pharmacopoeia Reagents


Chapters 2 and 4 of the European Pharmacopoeia describe the preparation of several hundred reagents and standards used for the testing of pharmaceutical raw materials. LGC Standards offers a large number of these ready-to-use reagents and standard solutions within the spectrum of this new catalogue. The primary solutions for coloration are produced by LGC Standards, the other reagents are manufactured by Reagecon. All are manufactured and tested in compliance with the prescriptions of EP. The products are supplied with certificates of analysis. Lot numbers and expiry dates are stated on all product labels as well. The reagents are always supplied as per the most recently issued EP supplement. Reagents from other pharmacopoeias are also available on request. Please contact your local LGC Standards office for further details.

Reagents as outlined in Chapter 2


Code Product Unit

REAEPPOSO1

Primary opalescence suspension

100 mL

Coloration: primary solutions


WESEPYS01 WESEPRS01 WESEPBS01 Coloration-primary solution yellow Coloration-primary solution red Coloration-primary solution blue 100 mL 100 mL 100 mL

Coloration: standard solutions


REAEP703 REAEP704 REAEP706 REAEP705 REAEP707 REAHADM1 Standard solution B (brown) Standard solution BY (brownish yellow) Standard solution Y (yellow) Standard solution GY (greenish yellow) Standard solution R (red) HCL dilution matrix (10 g/l HCl) 125 mL 100 mL 125 mL 125 mL 125 mL 1L

Reference buffer solutions - all @ 25C


REAEP168 REAEP401 REAEP687 REAEP741 REAEP918 ph Buffer solution 1.68 @ 25C ph Buffer solution 4.01 @ 25C ph Buffer solution 6.87 @ 25C ph Buffer solution 7.41 @ 25C ph Buffer solution 9.18 @ 25C 500 mL 500 mL 500 mL 500 mL 500 mL

Conductivity & resistivity solutions - @ 20C


REAEP1330 Conductivity standard
Electrolytic conductivity ............. 1330 S/cm at 20C Resistivity ................................................... 752 cm

500 mL

REAEP133

Conductivity standard
Electrolytic conductivity ............... 133 S/cm at 20C Resistivity ................................................. 7519 cm

500 mL

REAEP266

Conductivity standard 26.6 uS/cm


Electrolytic conductivity .............. 26.6 S/cm at 20C Resistivity ............................................... 37594 cm

500 mL

Reagents as outlined in Chapter 4 (4.1) of Ph. Eur.


REA1000401 REA1000402 REA1000501 REA1002501 REA1004702 REA1004703 REA1005201 REA1007301 REA1007302
Edition 2012/2013

Acetic acid (30%) Acetic acid, dilute (12%) Acetic anhydride solution R1 Alcohol, aldehyde free Ammonia, dilute R1 Ammonia, dilute R2 Ammonium carbonate solution Anisaldehyde, solution Anisaldehyde, solution R1
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

1L 1L 1L 1L 1L 1L 1L 100 mL 100 mL
313

European Pharmacopoeia Reagents


Code Product Unit

REA1009301 REA1009401 REA1011601 REA1012601 REA1012602 REA1012701 REA1012801 REA1012803 REA1012901 REA1015201 REA1022901 REA1023100 REA1023300 REA1031101 REA1032101 REA1032102 REA1037702 REA1038100 REA1039101 REA1039401 REA1039402 REA1043101 REA1043501 REA1043503 REA1043504 REA1045901 REA1046300 REA1048001 REA1048101 REA1048102 REA1052101 REA1053601 REA1054801 REA1054802 REA1055101 REA1055102 REA1056700 REA1056801 REA1057601 REA1058303 REA1058304 REA1058305 REA1058402 REA1062901 REA1063601 REA1063603 REA1063702 REA1063703 REA1065000 REA1065200 REA1065801
314

Barium chloride, solution R1 Barium hydroxide, solution Biuret reagent Bromocresol green solution Bromocresol green-methyl red solution Bromocresol purple solution Bromophenol blue solution Bromophenol blue solution R2 Bromothymol blue solution R1 Calcium sulphate solution Crystal violet solution Cupri-citric solution Cupri-tartaric (Solution I 500 mL & Solution II 500 mL) Dimidium bromide - sulphan blue mixed solution Diphenylamine solution Diphenylamine solution R1 Ferric ammonium sulphate solution R2 Ferroin Formaldehyde solution Fuchsin solution, decolorised Fuchsin solution, decolorised R1 Holmium perchlorate solution Hydrochloric acid R1 Hydrochloric acid, dilute Hydrochloric acid, dilute R1 Iodine bromide solution Iodoplatinate reagent Lanthanum nitrate solution Lead acetate cotton Lead acetate paper Mercuric bromide paper Methoxyphenylacetic reagent Methyl orange mixed solution Methyl orange solution Methyl red mixed solution Methyl red solution Molybdovanadic reagent Mordant black 11 triturate Naphtobenzein solution Ninhydrin, solution Ninhydrin solution R1 Ninhydrin solution R2 Nitric Acid, Dilute Perchloric acid solution Phenol red solution Phenol red solution R2 Phenolphthalein solution Phenolphthalein solution R1 Phosphomolybdotungstic reagent Phosphomolybdotungstic solution Picric acid solution
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

1L 1L 1L 100 mL 100 mL 100 mL 100 mL 100 mL 100 mL 1L 100 mL 1L 2x500 mL 1L 1L 1L 1l 100 mL 100 mL 100 mL 100 mL 1L 1L 1L 1L 1L 200 mL 1L 10 g Pck. Pck. 100 mL 100 mL 100 mL 100 mL 100 mL 100 mL 100 g 100 mL 100 mL 100 mL 100 mL 100 mL 100 mL 100 mL 500 mL 100 mL 100 mL 100 mL 100 mL 100 mL
Edition 2004/2005

European Pharmacopoeia Reagents


Code Product Unit

REA1065802 REA1069101 REA1069201 REA1069501 REA1069801 REA1070001 REA1070302 REA1070303 REA1070501 REA1070502 REA1070600 REA1070602 REA1070902 REA1071301 REA1071600-A REA1071600-B REA1075201 REA1078301 REA1078302 REA1079301 REA1081401 REA1081402 REA1081404 REA10816005 REA1083901 REA1085103 REA1086804 REA1089602 REA1090701 REA1094201 REA1102301 REA1096601 REA1096602

Picric acid solution R1 Potassium chloride, 0.1 M Potassium chromate, solution Potassium dichromate, solution Potassium ferrocyanide, solution Potassium hydrogen phthalate, 0.2 M Potassium hydroxide in alcohol (10% v/v) Potassium hydroxide solution alcoholic Potassium iodide and starch solution Potassium iodide solution Potassium iodobismuthate, solution Potassium iodobismuthate, solution R2 Potassium permanganate, solution Potassium pyroantimonate, solution Potassium tetraiodomercurate solution, alkaline (Part A) Potassium tetraiodomercurate solution, alkaline (Part B) Ruthenium red solution Silver nitrate solution R1 Silver nitrate solution R2 Sodium carbonate solution Sodium hydroxide solution Sodium hydroxide solution dilute Sodium hydroxide solution strong Sodium hypochlorite solution strong Sodium sulfure solution Starch, solution Sulphuric acid, dilute Thiocetamide solution Thymolphthalein solution Tris(hydroymethyl) aminomethane solution Zinc acetate solution Zinc chloride formic acid solution Zinc chloride solution, iodinated

100 mL 1L 1L 1L 100 mL 1L 1L 100 mL 125 mL 1L 100 mL 100 mL 1L 125 mL 100 mL 100 mL 100 mL 1L 1L 1L 1L 1L 1L 500 mL 100 mL 100 mL 1L 1L 100 mL 100 mL 1L 1L 1L

Standard solutions for limit tests as outlined in Chapter 4 (4.1.2) of Ph. Eur.
REA5000200 REA5000300C REA5000500C REA5000700C REA5000800C REA5000802C REA5000900C REA5001000 REA5001100 REA5001200C REA5001400C REA5001600C REA5001602C REA5001701C REA5001800C REA5002000C Aluminium standard solution (200 ppm Al) Ammonium standard solution (100 ppm NH4) Arsenic standard solution (10 ppm As) Cadmium standard solution (0.1% Cd) Calcium standard solution (400 ppm Ca) Calcium standard solution alcoholic (400 ppm Ca) Chloride standard solution (8 ppm CI) Chromium standard solution (100 ppm Cr) Copper standard solution (0.1% Cu) Ferrocyanide standard solution (100 ppm Fe) Fluoride standard solution (10 ppm F) Iron standard solution (20 ppm Fe) Iron standard solution (8 ppm Fe) Lead standard solution (100 ppm Pb) Magnesium standard solution (100 ppm Mg) Nickel standard solution (10 ppm Ni) 100 mL 100 mL 100 mL 100 mL 100 mL 1L 100 mL 1L 100 mL 100 mL 100 mL 100 mL 100 mL 100 mL 100 mL 100 mL

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

315

European Pharmacopoeia Reagents


Code Product Unit

REA5002100C REA5002200C REA5002400C REA5002700C REA5002800C REA5003100C REA5003401C

Nitrate standard solution (100 ppm NO3) Phosphate standard solution (5 ppm PO4) Potassium standard solution (100 ppm K) Sodium standard solution (200 ppm Na) Sulphate standard solution (10 ppm SO4) Tin standard solution (5 ppm Sn) Zinc standard solution (100 ppm Zn)

100 mL 100 mL 100 mL 100 mL 100 mL 1L 100 mL

Buffer solutions as outlined in Chapter 4 (4.1.3) of Ph. Eur.


REA4000100 REA4000600 REA4001400 REA4004800 REA4008300 REA4007200 REA4007300 Buffered acetone solution Buffer solution pH 3.5 Acetate buffer solution pH 4.6 Phosphate buffer solution pH 7.4 Buffer (phosphate) solution pH 9.0 Ammonium chloride buffer solution pH 9.5 Ammonium chloride buffer solution pH 10.0 1L 1L 1L 1L 1L 1L 1L

Volumetric solutions as outlined in Chapter 4 (4.2.2) of Ph. Eur.


REA3000100 REA3000200 REA3000300 REA3000500 REA3000600 REA3000900 REA3001100 REA3008700 REA3001300 REA3001500 REA3001700 REA3001800 REA3002100 REA3008800 REA3002700 REA3003100 REA3003300 REA3003500 REA3003900 REA3004200 REA3002900 REA3009100 REA3004800 REA3004900 REA3005000 REA3005100 REA3005300 REA3005600 REA3009300 REA3005800 REA3005900 REA3006300 REA3006600 REA3007000
316

0.1M Ammonium and cerium nitrate 0.01M Ammonium and cerium nitrate 0.1M Ammonium and cerium sulphate 0.1M Ammonium thiocyanate 0.1M Barium chloride 0.004M Benzethonium chloride 0.1M Cerium sulphate 1M Cupriethylenediamine hydroxide solution 0.1M Ferric ammonium sulphate 6M Hydrochloric acid 2M Hydrochloric acid 1M Hydrochloric acid 0.1M Hydrochloric acid 0.1M Hydrochloric acid, alcoholic 0.05M Iodine 0.1M Lead nitrate 0.1M Lithium methoxide 0.02M Mercuric nitrate 0.1M Perchloric acid 0.033M Potassium bromate 0.01M Iodine 11M Potassium hydroxide 0.1M Potassium hydroxide 0.5M Potassium hydroxide 0.5m Potassium Hydroxide, Alcoholic 0.1M Potassium hydroxide, alcoholic 0.02M Potassium permanganate 0.1M Silver nitrate 0.001M Sodium nitrate 0.1M Sodium arsenite 0.1M Sodium edetate 1M Sodium hydroxide 0.1M Sodium hydroxide 0.1M Sodium hydroxide, ethanolic
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L 1L
Edition 2004/2005

European Pharmacopoeia Reagents


Code Product Unit

REA3007100 REA3007200 REA3007300 REA3007800 REA3008000 REA3008300 REA3008400 REA3008600

0.1M Sodium methoxide 0.1M Sodium nitrate 0.1M Sodium thiosulphate 0.5M Sulphuric acid 0.05M Sulphuric acid 0.1M Tetrabutylammonium hydroxide 0.1M Tetrabutylammonium hydroxide in 2-propanol 0.1M Zinc sulphate

1L 1L 1L 1L 1L 1L 1L 1L

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

317

WHO International Standards for Antibiotics

WHO International Standards for Antibiotics


In 2006, the EDQM has been designated a WHO Collaborative Centre for the International Standards for Antibiotics (ISA). These standards are essential in the standardisation and quality control of antibiotic material and pharmaceutical products. They are supplied for assays described in the specifications for quality control of antibiotic material. The EDQM is for example responsible for the establishment and storage of the WHO ISA materials. All biological preparations listed in this catalogue are supplied exclusively as WHO ISA materials for use as primary standards in the establishment of National/Regional secondary working standards and for no other purpose. You can order the ISA materials directly with your supplies for other reference materials available from LGC Standards. For further information please contact your local LGC Standards office.

Code

Product

Unit

EPISA_28168 EPISA_29078 EPISA_29384 EPISA_39036 EPISA_62_003 EPISA_62_008 EPISA_62_013 EPISA_65_062 EPISA_66_231 EPISA_66_254 EPISA_67_301 EPISA_68_041 EPISA_72_406 EPISA_76_538 EPISA_76_539 EPISA_78_547 EPISA_80_543 EPISA_82_510 EPISA_83_521 EPISA_83_577 EPISA_90_704 EPISA_92_670 EPISA_TYN

Gramicidin Second International Standard for Amphotericin B Third International Standard for Nystatin Vancomycin Bacitracin Spiramycin Dihydrostreptomycin Colistin Rifamycin SV Colistin Methane Sulfonate Polymoyxin B Neomycin B Neomycin Erythromycin Streptomycin Bleomycin Complex A2/B2 Sisomicin Tobramycin Kanamycin Netilmicin Teicoplanin Gentamicin Tylosin

100 mg 100 mg 100 mg 100 mg 100 mg 50 mg 200 mg 75 mg 100 mg 75 mg 75 mg 25 mg 50 mg 75 mg 100 mg 7 mg 63 mg 11.2 mg 13 mg 7.5 mg 54 mg 50 mg 40 mg

318

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

British Pharmacopoeia

British Pharmacopoeia
Background
British Pharmacopoeia chemical reference substances (BPCRS) available from BP are issued under the authority of the British Pharmacopoeia Commission and are solely for use in tests and assays of the British Pharmacopoeia or the British Pharmacopoeia (Veterinary). The list in this catalogue is current as of July 2012, and includes all available BPCRS needed to follow the current official monographs. Most BP monographs for active substances conform with the monographs issued by the European Pharmacopoeia, and so require the use of European Pharmacopoeia chemical reference substances. Details of these are to be found under the European Pharmacopoeia section of this catalogue.

Production and certification


British Pharmacopoeia reference substances and preparations are selected and verified by the BP Laboratories as being suitable for the use as prescribed in the relevant monographs of the British Pharmacopoeia.

Documentation
BPCRS are of two types normal CRS for identification purposes and Assay Standards. Assay Standards are provided with a documented assay value, determined by the BP Laboratories. The BP laboratories do not make available any other BPCRS certificates of analysis or other information, in connection with the prescribed use of the BPCRS.

Controlled substances
Controlled drugs are subject to import and export control restrictions. Please contact LGC Standards for details.

Shelf life, expiry dates and size units


British Pharmacopoeia chemical reference substances are subjected to regular inspection and repeat analysis by BP scientific staff. Each BPCRS is, on receipt by the customer, fit for the intended use. BP supplies only current lots. Formally, all BPCRS are supplied with three months shelf life. For this reason users are advised to order only as many units as required immediately. Please note, that new lots can have different unit sizes, especially with pharmacopoeial reference standards, and LGC Standards is not responsible for such cases. If the unit size of a new batch changes, LGC Standards will provide this information to customers in new lot lists. Once opened, BP can no longer guarantee the stability of the material and any of the CRS/BRP not used should be disposed of and not kept for future use.

Products
Code Product Unit

BP 001 BP 904 BP 681 BP 907 BP 438 BP 003 BP 763 BP 436 BP 006 BP 007 BP 825 New BP 847 BP 415 New BP 870 BP 831 BP 832
Edition 2012/2013

Acepromazine maleate Acetazolamide Assay Standard 4-Acetyl 2-fluorobiphenyl Acetylcysteine Assay Standard Aciclovir Assay Standard Adrenaline (epinephrine) acid tartrate Assay Standard Albendazole Assay Standard Alexandrian senna fruit powder Assay Standard Alfadolone acetate Assay Standard Alfaxalone Assay Standard Alfuzosin hydrochloride Assay Standard Alfuzosin impurity standard Alimemazine tartrate Assay Standard Allopurinol Allopurinol Impurity A Allopurinol Impurity B
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

50 mg 600 mg 25 mg 200 mg 100 mg 100 mg 100 mg 1g 100 mg 100 mg 100 mg 25 mg 100 mg 200 mg 20 mg 10 mg
321

British Pharmacopoeia
Code Product Unit

BP 843 BP 844 BP 845 BP 560 BP 725 BP 724 BP 530 BP 853 BP 008 BP 010 BP 374 BP 839 BP 813 BP 012 BP 011 BP 602 BP 684 BP 881 BP 417 BP 601 BP 536 BP 014 BP 532 BP 785 BP 021 BP 015 BP 016 BP 019 BP 748 BP 546 BP 694 BP 461 BP 617 BP 492 BP 370 BP 023 BP 366 BP 024 BP 025 BP 534 BP 515 BP 516 BP 517 BP 527 New BP 026 BP 028 BP 535 BP 030 BP 760 BP 761 BP 685
322

Allopurinol Impurity C Allopurinol Impurity D Allopurinol Impurity E 9-Allyl-2-chlorothioxanthen-9-ol Alverine citrate Assay Standard Alverine citrate impurity standard solution Amantadine hydrochloride Assay Standard Amikacin sulfate Assay Standard Amiloride hydrochloride Assay Standard 4-Amino-6-chlorobenzene-1-3-disulphonamide 3-Amino-6-chloro-1-methyl-4-phenylquinolin-2-ol 3-amino-4-(2-chlorophenyl)-6-nitroquinolin-2(1H)-one 2-Amino-5-chloropyridine 2-Amino-4,6-Dichlorophenol hydrochloride 7-Aminodesacetoxycephalosporanic acid (E)-4-Amino-2-ethylidenebutyric acid hydrochloride Aminoglutethimide Assay Standard Aminoglutethimide impurity A 2-Amino-1-(4-nitrophenyl)propane-1,3-diol 3-Aminopent-4-ene-1,1-dicarboxylic acid 3-Amino-4-phenoxy-5-sulphamoylbenzoic acid 3-Amino-4-propoxybenzoic acid Amiodarone hydrochloride Assay Standard Anhydrous Ampicillin Assay Standard Ampicillin trihydrate Amitraz Assay Standard Amitriptyline hydrochloride Assay Standard Amoxicillin Trihydrate Assay Standard Amoxicillin impurity standard Apramycin Arginine hydrochloride Assay Standard Ascorbic acid Aspirin Assay Standard Atenolol Assay Standard Atenolol impurity standard Atropine sulfate Assay Standard 1-(3-Azabicyclo[3.3.0]oct-3-yl)-3-o-tolylsulphonylurea 2-Azahypoxanthine Azaperone Assay Standard Azapropazone Assay Standard Azapropazone Impurity A Azapropazone Impurity B Azapropazone Impurity C Azapropazone impurity standard Azathioprine Assay Standard Baclofen Assay Standard Baclofen lactam Beclometasone dipropionate Assay Standard Beclometasone 17-propionate Beclometasone 21-propionate Benserazide hydrochloride Assay Standard
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

10 mg 10 mg 20 mg 25 mg 100 mg 1 mL 200 mg 200 mg 100 mg 50 mg 50 mg 25 mg 25 mg 50 mg 20 mg 25 mg 100 mg 20 mg 50 mg 25 mg 25 mg 50 mg 100 mg 250 mg 500 mg 200 mg 150 mg 500 mg 25 mg 250 mg 100 mg 100 mg 100 mg 100 mg 50 mg 200 mg 30 mg 50 mg 100 mg 100 mg 10 mg 10 mg 10 mg 50 mg 100 mg 150 mg 25 mg 100 mg 25 mg 25 mg 100 mg
Edition 2012/2013

British Pharmacopoeia
Code Product Unit

New BP 968 BP 036 BP 610 BP 426 BP 611 BP 037 BP 609 BP 824 BP 575 BP 041 BP 042 BP 043 BP 686 BP 755 BP 046 BP 047 BP 612 BP 613 BP 050 BP 440 BP 793 New BP 894 BP 537 BP 479 BP 403 BP 192 BP 531 BP 766 BP 355 BP 059 BP 538 BP 477 BP 523 BP 060 BP 749 BP 711 BP 767 BP 567 BP 792 BP 784 BP 061 BP 562 BP 819 BP 820 BP 063 BP 976 BP 977 BP 502 BP 925 BP 757 BP 926
Edition 2012/2013

Benserazide Impurity A Benzatropine mesilate Assay Standard Benzydamine hydrochloride Assay Standard Benzyl benzoate Assay Standard 1-Benzyl-3-(3-diethylamino-propoxy)-1H-indazole (1S,2R)-1-benzyl-3-dimethylamino-2-methyl-1-phenylpropyl acetate 1-Benzyl-1-H-indazol-3-ol Betahistine dihydrochloride Assay Standard Betamethasone Assay Standard Betamethasone sodium phosphate Betamethasone valerate Assay Standard Betamethasone 21-valerate Betaxolol hydrochloride Assay Standard Bezafibrate Assay Standard 2-(Biphenyl-4-yl)propionic acid Bisacodyl Assay Standard Bretylium tosilate Assay Standard 2-Bromobenzyldimethylamine hydrochloride Bromocriptine Mesilate Assay Standard Buclizine hydrochloride impurity standard Budesonide Assay Standard Budesonide impurity standard Bumetanide Assay Standard Bupivacaine hydrochloride Assay Standard Busulfan Assay Standard 2-tert-Butylamino-1-(4-hydroxy-3-methylphenyl)ethanol sulphate 2-Butyl-3-(4-hydroxy-3,5-di-iodobenzoyl)benzofuran Caffeine Assay Standard Calcitonin (salmon) Assay Standard Capreomycin sulfate Captopril Assay Standard 2-Carbamoyl-1-methyl-3-[2-(5-methylimidazol-4-yl-methylthio)ethyl]guanidine dihydrochloride Carbaryl Assay Standard Carbidopa Assay Standard Carbimazole Assay Standard Carboplatin Assay Standard Carmellose sodium Assay Standard Carteolol hydrochloride Assay Standard Cefaclor Assay Standard Cefadroxil Assay Standard Cefalexin Assay Standard Cefalonium Assay Standard Cefazolin Sodium Cefoxitin Sodium Assay Standard Cefradine Assay Standard Ceftriaxone sodium Assay Standard Ceftriaxone sodium E-isomer Cefuroxime axetil Assay Standard Cefuroxime sodium Assay Standard Celiprolol hydrochloride Assay Standard Chenodeoxycholic acid
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

20 mg 100 mg 100 mg 0.1 mL 50 mg 25 mg 50 mg 100 mg 100 mg 100 mg 100 mg 50 mg 100 mg 100 mg 25 mg 100 mg 200 mg 0.1 mL 100 mg 50 mg 110 mg 10 mg 100 mg 100 mg 25 mg 25 mg 25 mg 100 mg 1 mL 50 mg 100 mg 25 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 450 mg 100 mg 150 mg 100 mg 150 mg 200 mg 300 mg 100 mg 10 mg 100 mg 150 mg 100 mg 25 mg
323

British Pharmacopoeia
Code Product Unit

BP 064 BP 854 BP 067 BP 068 BP 441 BP 756 BP 604 BP 376 BP 442 BP 470 BP 049 BP 446 BP 071 BP 965 BP 378 BP 443 BP 074 BP 075 BP 076 BP 559 BP 077 BP 079 BP 080 BP 081 BP 856 BP 467 BP 491 BP 783 BP 618 BP 475 BP 809 New BP 929 BP 833 BP 834 BP 525 BP 084 BP 507 BP 522 BP 521 BP 482 BP 406 BP 663 BP 543 BP 980 BP 983 BP 981 BP 484 BP 085 BP 565

Chlorambucil Assay Standard Chloramphenicol Assay Standard Chlorcyclizine hydrochloride Chlorhexidine acetate Assay Standard 1,4-bis(4-Chlorobenzhydryl)piperazine N-p-chlorobenzoyltyramine 4-Chlorobenzylphthalazinone 6-Chloro-4-(2-chlorophenyl)quinazoline-2-carboxaldehyde 6-Chloro-1,4-dihydro-1-methyl-4-phenylquinazolin-4-ol 7-Chloro-1-5-dihydro-5-phenyl-1,5-benzodiazepine-2,4(3H)-dione 17,17'-bis(3-[bis-(2-chloroethyl)carbamoyloxy] estra-1,3,5,(10)-trienyl)pyrophosphate 5-(2-Chloroethyl)-4-methyl-3-[2-(4-methylthiazol-5-yl)ethyl]thiazolium chloride 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide 5-Chloro-1-methyl-4-nitroimidazole 5-Chloro-2-methylaminobenzophenone 6-(2-Chlorophenyl)-2,4-dihydro-2-[(dimethylamino)methylene] 8-nitroimidazo[1,2-a][1,4]benzodiazepin-1-one 4-Chloro-5-sulphamoylanthranilic acid 2-(4-Chloro-3-sulphamoylbenzoyl)benzoic acid Chlorothiazide 2-Chlorothioxanthone 2-(6-Chlorothymoxy)ethyldimethylamine hydrochloride 2-Chlorotritanol Chloroxylenol Assay Standard Chlorphenamine maleate Assay Standard Chlorpromazine hydrochloride Chlorpromazine sulphoxide Chlortalidone Assay Standard Chlortetracycline hydrochloride Assay Standard Cholic acid Assay Standard Cimetidine Assay Standard Cisplatin Assay Standard Ciprofloxacin Hydrochloride Assay Standard Clarithromycin Assay Standard Clarithromycin Impurity E Clemastine fumarate Assay Standard Clioquinol Assay Standard Clobazam Assay Standard Controlled Substance Clobetasol Impurity A Clobetasol propionate Assay Standard Clobetasone butyrate Assay Standard Clocortolone hexanoate Clofazimine Assay Standard Clomethiazole edisilate Assay Standard Clomipramine hydrochloride Clomipramine Impurity F Clomipramine Impurity C Clonazepam Assay Standard Controlled Substance Clonidine hydrochloride Assay Standard trans-Clopenthixol acetate dihydrochloride

100 mg 500 mg 100 mg 100 mg 25 mg 25 mg 25 mg 50 mg 25 mg 25 mg 25 mg 25 mg 25 mg 100 mg 50 mg 25 mg 25 mg 25 mg 100 mg 25 mg 25 mg 25 mg 500 mg 100 mg 50 mg 50 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 20 mg 200 mg 200 mg 100 mg 25 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 10 mg 10 mg 100 mg 100 mg 50 mg

324

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

British Pharmacopoeia
Code Product Unit

BP 566 BP 561 BP 628 BP 379 BP 088 BP 905 BP 091 BP 715 BP 514 BP 090 BP 787 BP 614 BP 551 BP 585 BP 094 BP 466 BP 478 BP 096 BP 886 BP 098 BP 380 BP 688 BP 383 BP 100 BP 771 BP 428 BP 429 BP 102 BP 103 BP 104 BP 791 BP 572 BP 631 BP 632 BP 789 BP 889 BP 504 BP 730 BP 987 BP 931 BP 689 BP 568 BP 816 BP 817 BP 594 BP 578 BP 108 BP 646 BP 811 BP 465 BP 549
Edition 2012/2013

trans-Clopenthixol decanoate dihydrochloride trans-Clopenthixol hydrochloride Cloprostenol sodium Assay Standard Clotrimazole Assay Standard Cloxacillin benzathine Assay Standard Clozapine Assay Standard Co-dergocrine mesilate Assay Standard Cocaine hydrochloride Assay Standard Controlled Substance Codeine hydrochloride Assay Standard Controlled Substance Codeine Phosphate Assay Standard Controlled Substance Colecalciferol Assay Standard Colestipol hydrochloride Colestyramine Assay Standard Cortisone acetate Assay Standard Crotamiton Assay Standard Cyanocobalamin Assay Standard 2-Cyano-1-methyl-3-[2-(5-methylimidazol-4-yl-methylsulphinyl)ethyl]guanidine Cyclizine hydrochloride Assay Standard Cyclobenzaprine hydrochloride Cyclopenthiazide Cyclopentolate hydrochloride Assay Standard Cyproterone acetate Assay Standard Cytarabine Assay Standard Dacarbazine Dantrolene Assay Standard Dantron Dantron impurity standard Dapsone Assay Standard Debrisoquine sulfate Decoquinate Delta-3-Cefaclor Deltamedrane Deltamethrin Assay Standard Deltamethrin impurity standard Demeclocycline hydrochloride Assay Standard N-Demethylerythromycin A Desacetylmetipranolol N-Desalkylflurazepam Desferrioxamine mesilate Desipramine hydrochloride Desmethyl benzatropine hydrochloride Desogestrel Assay Standard Desogestrel Impurity D Desogestrel Impurity E Desogestrel 3-isomer Dexamethasone Assay Standard Dexamethasone sodium phosphate Dexamethasone phosphate Assay Standard Dexamethasone impurity standard Dextropropoxyphene HCl Assay Standard Controlled Substance Diacetylfluorescein Assay Standard
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

25 mg 25 mg 50 mg 50 mg 250 mg 100 mg 50 mg 100 mg 100 mg 200 mg 500 mg 50 mg 500 mg 100 mg 100 mg 150 mg 25 mg 100 mg 25 mg 100 mg 100 mg 100 mg 100 mg 25 mg 100 mg 50 mg 100 mg 100 mg 100 mg 50 mg 20 mg 25 mg 100 mg 40 mg 100 mg 10 mg 25 mg 25 mg 30 mg 100 mg 50 mg 100 mg 25 mg 25 mg 25 mg 100 mg 50 mg 100 mg 25 mg 100 mg 200 mg
325

British Pharmacopoeia
Code Product Unit

BP 887 BP 111 BP 114 BP 124 BP 858 BP 608 BP 116 BP 420 BP 721 BP 619 BP 598 BP 828 BP 810 BP 118 BP 361 BP 737 BP 119 BP 859 BP 677 BP 401 BP 397 BP 855 BP 431 BP 120 BP 122 BP 815 BP 726 BP 899 BP 582 BP 195 BP 607 BP 456 BP 865 BP 866 BP 511 BP 364 BP 690 BP 691 BP 902 BP 896 BP 128 BP 673 BP 659 BP 589 BP 131 BP 384 BP 615 BP 132 BP 385 BP 674

Diamorphine Hydrochloride Assay Standard Controlled Substance Diazepam Controlled Substance Dibenzo[b,e]thiepin-11(6H)-one 3-(Dibenzo[b,e]thiepin-11(6H)-ylidene)-N,N-dimethylaminopropan1-amine-S-oxide hydrochloride Dibenzosuberone 3-(1,5-Dibenzyl-1H-indazole-3-yl)oxypropyl dimethylamine hydrochloride Dichlorophen Assay Standard Dichlorophen impurity standard Assay Standard 1-(2,5-Dichlorophenyl)-5-isopropylbiguanide hydrochloride Diclofenac sodium Assay Standard Diclofenac diethylamine Diclofenac Impurity A Dicloxacillin sodium Diethanolamine fusidate Assay Standard 2-Diethylaminoethyl-3-(1-naphthyl)-2-(1-naphthylmethyl)propionate oxalate Diethylcarbamazine citrate Diethyl-4-decyloxy-3-ethoxyanilinomethylenemalonate Diethylstilbestrol Assay Standard Diethyl stilbestrolmonophosphate Diflucortolone valerate Assay Standard Diflucortolone valerate impurity standard Digitoxin Assay Standard Dihydrocodeine Tartrate Assay Standard Controlled Substance Dihydroergocristine mesilate 2,3-Dihydro-6-phenylimidazo [2,1-b] thiazole bis-(1,7-dihydro-6H-purine)-6,6-disulphide Diltiazem HCl Diltiazem impurity standard 6,6-Dimethoxy-2,2'-binaphthyl 4-Dimethylamino-3-methyl-1,2-diphenylbutan-2-ol hydrochloride 3-Dimethylaminopropyl 2-benzylaminobenzoate hydrochloride 1,5-Dimethylhexyl(methyl)amine Dimethyl-2,6-dimethyl-4-(2-nitrophenyl)pyridine-3,5-dicarboxylate Dimethyl-2,6-dimethyl-4-(2-nitrosophenyl)pyridine-3,5-dicarboxylate Dimethyl{5-[2-(1-methylamino-2-nitrovinylamino) ethylsulphinylmethyl]furfuryl}amine 2,2-Dimethyl-5(2,4-xylyloxy)valeric acid Dimpylate Assay Standard Dimpylate for chromatography Dinoprostone Assay Standard Diphenhydramine hydrochloride Dipipanone hydrochloride Assay Standard Controlled Substance Dipivefrine hydrochloride Assay Standard Dipivefrine impurity standard Diprenorphine Assay Standard Dipyridamole Assay Standard N1,N2-Diquinoxalin-2-ylsulphanilamide Disodium pamidronate Assay Standard Disulfiram Assay Standard Dithranol Assay Standard Dobutamine hydrochloride Assay Standard

150 mg 100 mg 25 mg 25 mg 100 mg 25 mg 100 mg 100 mg 25 mg 100 mg 100 mg 25 mg 250 mg 100 mg 25 mg 100 mg 50 mg 100 mg 25 mg 100 mg 25 mg 250 mg 100 mg 25 mg 50 mg 25 mg 100 mg 25 mg 25 mg 25 mg 25 mg 50 mg 25 mg 25 mg 25 mg 25 mg 100 mg 0.1 mL 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 25 mg 100 mg 50 mg 100 mg 100 mg

326

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

British Pharmacopoeia
Code Product Unit

BP 133 BP 669 BP 468 BP 134 BP 135 BP 136 BP 823 BP 990 BP 780 BP 675 BP 138 BP 139 BP 741 BP 742 BP 743 BP 387 New BP 871 BP 992 BP 788 BP 405 BP 141 BP 781 BP 794 BP 795 BP 796 BP 790 BP 798 BP 488 BP 396 BP 729 BP 142 BP 752 BP 753 BP 860 BP 616 BP 143 BP 421 BP 145 BP 146 BP 150 BP 437 BP 149 BP 529 BP 533 BP 541 BP 542 BP 885 BP 653 BP 655 BP 656 BP 654
Edition 2012/2013

Docusate sodium Assay Standard Domperidone maleate Assay Standard Dopamine hydrochloride Assay Standard Dosulepin hydrochloride Assay Standard Doxapram hydrochloride Assay Standard Doxepin hydrochloride Assay Standard Doxepin impurity standard Doxorubicin hydrochloride Assay Standard Doxycycline hyclate Assay Standard Droperidol Assay Standard Dydrogesterone Econazole nitrate Assay Standard Enalapril maleate Enalaprilat Enalapril diketopiperazine Ephedrine hydrochloride Assay Standard Drug Precursor 6-Epidoxycycline hydrochloride Epirubicin hydrochloride Ergocalciferol Assay Standard Ergometrine maleate Assay Standard Drug Precursor Ergotamine tartrate Assay Standard Drug Precursor Erythromycin Erythromycin A Assay Standard Erythromycin B Assay Standard Erythromycin C Assay Standard Erythromycin estolate Erythromycin ethyl succinate Erythromycin stearate Assay Standard Estradiol benzoate Assay Standard Estradiol hemihydrate Assay Standard Estramustine Estriol Assay Standard Estriol impurity standard Estrone Estropipate Assay Standard Etacrynic acid Assay Standard Ethinylestradiol Assay Standard Ethopabate Assay Standard Ethosuximide Assay Standard Ethyldimethyl [2-(2-methylbenzhydryloxy)ethyl]ammonium chloride N-Ethylglucamine hydrochloride Ethyl meclofenamate Etodolac Assay Standard Etodolac acid dimer Etodolac 1-methyl analogue Etodolac 8-methyl analogue Etoposide Assay Standard Famotidine Assay Standard Famotidine degradation impurity 1 Famotidine degradation impurity 2 Famotidine Impurity C
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

200 mg 100 mg 100 mg 100 mg 100 mg 100 mg 1 mg 100 mg 100 mg 100 mg 50 mg 100 mg 100 mg 20 mg 20 mg 100 mg 50 mg 100 mg 500 mg 100 mg 50 mg 50 mg 250 mg 50 mg 50 mg 100 mg 50 mg 100 mg 50 mg 100 mg 25 mg 100 mg 25 mg 25 mg 100 mg 100 mg 100 mg 100 mg 200 mg 25 mg 500 mg 25 mg 150 mg 10 mg 10 mg 10 mg 150 mg 100 mg 25 mg 25 mg 25 mg
327

British Pharmacopoeia
Code Product Unit

BP 620 BP 777 BP 758 BP 692 BP 693 BP 354 BP 661 BP 660 BP 665 BP 666 BP 156 BP 740 BP 571 BP 676 BP 159 BP 840 BP 160 BP 489 BP 161 BP 162 BP 163 BP 573 BP 797 BP 164 BP 738 BP 554 BP 556 BP 597 BP 167 BP 574 BP 587 BP 588 BP 600 BP 671 New BP 937 BP 627 BP 639 New BP 997 BP 623 BP 678 BP 547 BP 643 BP 363 BP 303 BP 365 BP 174 BP 175 BP 368 BP 580

Felbinac Assay Standard Felodipine Assay Standard Felodipine impurity standard Fenbendazole Fenbendazole Impurity C {5-(phenylthio)-2-aminobenzimidazole} Fenbufen Assay Standard Fenoterol degradation Impurity A Fenoterol hydrobromide Assay Standard Fentanyl citrate Assay Standard Controlled Substance Fentanyl Impurity A Fenthion Assay Standard Finasteride Assay Standard Flavoxate hydrochloride Assay Standard Flecainide acetate Assay Standard Fludrocortisone acetate Assay Standard Flunitrazepam Controlled Substance Fluocinolone acetonide Assay Standard Fluocinonide Assay Standard Fluocortolone hexanoate Assay Standard Fluocortolone pivalate Assay Standard 4'-Fluoro-4-chlorobutyrophenone Fluorometholone Assay Standard Fluoxetine hydrochloride Assay Standard Fluoxymesterone Controlled Substance cis-Flupentixol Flupentixol decanoate dihydrochloride Assay Standard trans-Flupentixol decanoate dihydrochloride cis-Flupenthixol propionate dihydrochloride Fluphenazine hydrochloride Assay Standard Flurbiprofen sodium Assay Standard Fluticasone propionate Assay Standard Fluticasone S-methyl impurity Fluvoxamine maleate Assay Standard Fluvoxamine maleate impurity standard Folic acid Assay Standard 3-Formylrifamycin SV Form-2',4'-xylidide Foscarnet Impurity B Foscarnet sodium Assay Standard Fosfestrol sodium Furosemide Assay Standard Gallamine impurity standard Gemfibrozil Assay Standard Gemfibrozil impurity A 2,2-dimethyl-5-(4-propen-1-yl)-2,5-xylyloxy)valeric acid Gemfibrozil methyl ester Gentamicin sulfate Glibenclamide Assay Standard Gliclazide Assay Standard Gliquidone Assay Standard

100 mg 100 mg 20 mg 100 mg 25 mg 100 mg 25 mg 100 mg 100 mg 25 mg 0.25 mL 100 mg 100 mg 100 mg 50 mg 25 mg 50 mg 100 mg 50 mg 50 mg 0.5 mL 100 mg 250 mg 50 mg 25 mg 100 mg 25 mg 100 mg 100 mg 100 mg 100 mg 25 mg 100 mg 100 mg 150 mg 25 mg 25 mg 10 mg 100 mg 50 mg 100 mg 100 mg 100 mg 10 mg 0.1 mL 25 mg 100 mg 200 mg 150 mg

328

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

British Pharmacopoeia
Code Product Unit

BP 581 BP 652 BP 814 BP 180 BP 181 BP 879 BP 407 BP 185 BP 186 BP 576 BP 584 BP 187 BP 188 BP 190 BP 770 BP 197 BP 526 BP 196 BP 829 BP 888 BP 194 BP 198 BP 199 BP 774 BP 539 New BP 880 BP 202 BP 759 BP 664 BP 932 BP 999 BP 1000 BP 625 BP 557 BP 550 New BP 1083 BP 205 BP 778 BP 206 BP 799 BP 800 BP 499 BP 626 BP 621 BP 622 BP 624 BP 864 BP 861 BP 736 BP 668 BP 667
Edition 2012/2013

Gliquidone sulphonamide Glyceryl trinitrate solution Assay Standard Goserelin Hexapeptide Griseofulvin Assay Standard Guanethidine monosulfate Assay Standard Guanine Haloperidol Assay Standard Homatropine hydrobromide Assay Standard Hydrochlorothiazide Assay Standard Hydrocortisone Assay Standard Hydrocortisone acetate Assay Standard Hydrocortisone Hydrogen Succinate Hydrocortisone sodium phosphate Hydroflumethiazide 4'Hydroxyacetophenone Hydroxycarbamide Assay Standard 2-(2-Hydroxyethyl)-1-methylpyrrolidine 5-[1-Hydroxy-2-(1-methyl-3-phenylpropylamino)ethyl]salicylic acid hydrochloride D-alpha-(4-hydroxyphenyl)glycine (5RS)-3-(2-hydroxyphenyl)-5-phenylcyclohex-2-enone 2-(6-Hydroxythymoxy)ethyldimethylamine hydrochloride Hyoscine butylbromide Assay Standard Hyoscine Hydrobromide Assay Standard Hypromellose Assay Standard Ibuprofen Assay Standard Ibuprofen Impurity B Idoxuridine Assay Standard Ifosfamide Assay Standard Iminophenazine Imipramine hydrochloride Indapamide Assay Standard Indapamide Impurity B Ipratropium bromide Assay Standard 4'-Isobutylacetophenone Isoconazole nitrate Assay Standard Isoniazid Assay Standard Isoprenaline hydrochloride Assay Standard Isopromethazine hydrochloride Isosorbide dinitrate Isosorbide 2-nitrate Isosorbide mononitrate Assay Standard 4'-(2-Isopropylaminoethyl)methanesulphonanilide hydrochloride 8s-Isopropyl-3-hydroxytropanium bromide Isradipine Assay Standard Isradipine Impurity B Isradipine Impurity D Ivermectin Assay Standard Kanamycin monosulfate Ketamine Hydrochloride Controlled Substance Ketoprofen Assay Standard Ketoprofen ethyl ester
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

25 mg 50 mL 10 mg 100 mg 100 mg 25 mg 150 mg 100 mg 200 mg 100 mg 100 mg 100 mg 100 mg 100 mg 25 mg 200 mg 0.1 mL 50 mg 50 mg 25 mg 25 mg 100 mg 200 mg 100 mg 200 mg 1.15 mL 100 mg 100 mg 25 mg 50 mg 150 mg 10 mg 100 mg 100 mg 100 mg 100 mg 100 mg 25 mg 300 mg 50 mg 100 mg 25 mg 25 mg 100 mg 25 mg 25 mg 250 mg 50 mg 100 mg 100 mg 100 mg
329

British Pharmacopoeia
Code Product Unit

BP 707 BP 647 BP 802 BP 872 BP 873 BP 212 BP 356 BP 213 BP 772 BP 723 BP 634 BP 501 BP 215 BP 727 BP 733 BP 695 BP 696 BP 433 BP 927 BP 697 BP 635 BP 636 BP 874 BP 875 BP 447 BP 434 BP 528 BP 867 BP 218 BP 776 BP 1008 BP 220 BP 221 BP 222 BP 223 New BP 1077 BP 629 BP 630 BP 391 BP 699 BP 583 BP 773 BP 762 BP 496 BP 226 BP 227 BP 552 BP 232 New BP 1078 BP 644 BP 606
330

Lacidipine Assay Standard Lacidipine impurity standard Lamivudine Assay Standard Lansoprazole Assay Standard Lansoprazole impurity standard Levamisole hydrochloride Levobunolol hydrochloride Assay Standard Levodopa Assay Standard Levomenthol Assay Standard Levomepromazine maleate Assay Standard Levomepromazine sulphoxide Levonorgestrel Assay Standard Lincomycin hydrochloride Assay Standard Lidocaine Assay Standard Linseed oil Lisinopril dihydrate Assay Standard Lisinopril diketopiperazine Lithium lactate Assay Standard Lithocholic acid Lofepramine hydrochloride Assay Standard Loperamide hydrochloride Assay Standard Loperamide N-oxide Loratadine Assay Standard Loratadine impurity standard Loprazolam mesilate Controlled Substance Lorazepam Assay Standard Controlled Substance Lormetazepam Assay Standard Controlled Substance Losartan Potassium Assay Standard Lymecycline Lynestrenol Mebendazole Meclozine hydrochloride Medroxyprogesterone acetate Assay Standard Megestrol Megestrol acetate Assay Standard Melatonin Assay Standard Meloxicam Assay Standard Meloxicam impurity standard Melphalan Assay Standard Mepivacaine hydrochloride Assay Standard Meptazinol hydrochloride Assay Standard Mercaptopurine Assay Standard Mercaptopurine impurity standard Mesoridazine besilate Metaraminol tartrate Metformin hydrochloride Assay Standard Methadone hydrochloride Assay Standard Controlled Substance 1-(2-Methoxyphenyl)piperazine 5-Methoxytryptamine Methyl 4-acetamido-2-hydroxybenzoate 1-Methylazepan-4-one hydrochloride
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 25 mg 200 mg 100 mg 25 mg 100 mg 100 mg 100 mg 100 mg 100 mg 25 mg 100 mg 250 mg 100 mg 0.5 mL 100 mg 25 mg 100 mg 25 mg 100 mg 100 mg 25 mg 100 mg 25 mg 50 mg 50 mg 100 mg 150 mg 100 mg 25 mg 10 mg 100 mg 100 mg 25 mg 100 mg 100 mg 100 mg 50 mg 100 mg 100 mg 100 mg 100 mg 25 mg 50 mg 100 mg 100 mg 100 mg 25 mg 25 mg 25 mg 25 mg
Edition 2012/2013

British Pharmacopoeia
Code Product Unit

BP 605 BP 239 BP 240 BP 241 BP 569 BP 570 BP 444 BP 457 BP 476 BP 237 BP 244 BP 245 BP 641 BP 662 BP 248 BP 249 BP 846 BP 445 BP 409 BP 642 BP 357 BP 540 BP 603 BP 735 BP 251 BP 252 BP 253 BP 884 BP 722 BP 394 BP 637 BP 842 BP 768 BP 254 BP 648 New BP 804 BP 358 BP 851 BP 362 BP 548 BP 257 BP 425 BP 259 BP 260 BP 360 BP 435 BP 460 BP 395 BP 462 BP 651
Edition 2012/2013

1-Methyl-4-(2-benzoylhydrazino)azepan hydrochloride 3-Methyl-2,2-diphenyl-4-piperidinobutyronitrile Methyldopa Assay Standard Methyldopate hydrochloride Assay Standard 3-Methylflavone-8-carboxylic acid 3-Methylflavone-8-carboxylic acid ethyl ester 4-methyl-5-(2-hydroxyethyl)thiazole 2-Methyl-6-methylaminoheptan-2-ol 1-methyl-3-[2-(5-methylimidazol-4-yl-methylthio)ethyl]guanidine dihydrochloride Methyl N-4[2-(5-chloro2-methoxybenzamido)ethyl]benzenesulphonyl carbamate 2-Methyl-5-Nitroimidazole (1-Methyl-5-nitroimidazol-2-yl)methanol N-Methyl-N'-(2,4-xylyl)formamidine hydrochloride Methylphenobarbital Assay Standard Controlled Substance Methylprednisolone Assay Standard Methylprednisolone acetate Assay Standard N-methyl-bis[beta-(2-pyridyl)ethyl]amine trihydrochloride 4-Methyl-5-vinylthiazole edisilate Methysergide maleate Assay Standard Metipranolol Assay Standard Metoclopramide hydrochloride Assay Standard Metoprolol tartrate Assay Standard Metronidazole Assay Standard Metronidazole benzoate Mexenone Mianserin hydrochloride Assay Standard Miconazole nitrate Assay Standard Miconazole Impurity A Midazolam Assay Standard Controlled Substance Minocycline hydrochloride Assay Standard Minoxidil Assay Standard Mirtazapine Assay Standard Mometasone furoate Assay Standard Monosulfiram Morphine sulphate Assay Standard Controlled Substance Mupirocin lithium Assay Standard Nabumetone Assay Standard Nabumetone Impurity D Naftidrofuryl oxalate Assay Standard Naloxone hydrochloride Assay Standard Nandrolone Assay Standard Controlled Substance Nandrolone decanoate Controlled Substance Nandrolone laurate Controlled Substance Nandrolone Phenylpropionate Assay Standard Controlled Substance 3-(1-Naphthyl)-2-tetrahydrofurfurylpropionic acid Naproxen Assay Standard Nicotinamide Assay Standard Nicotinyl alcohol tartrate Nifedipine Assay Standard Nimodipine Assay Standard
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

25 mg 50 mg 100 mg 100 mg 25 mg 25 mg 25 mg 50 mg 25 mg 25 mg 50 mg 25 mg 30 mg 100 mg 100 mg 200 mg 25 mg 25 mg 50 mg 100 mg 100 mg 100 mg 150 mg 100 mg 100 mg 100 mg 100 mg 25 mg 100 mg 125 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 200 mg 100 mg 100 mg 100 mg 100 mg 50 mg 50 mg 100 mg 25 mg 100 mg 100 mg 50 mg 100 mg 100 mg
331

British Pharmacopoeia
Code Product Unit

BP 262 BP 263 BP 367 BP 512 BP 266 BP 267 BP 670 BP 714 BP 269 BP 765 BP 808 BP 806 BP 805 BP 272 BP 764 BP 700 BP 701 BP 273 BP 782 BP 276 BP 769 BP 277 BP 371 New BP 1024 BP 746 BP 278 BP 1073 New BP 1074 BP 422 BP 683 BP 901 BP 282 BP 520 BP 703 BP 284 BP 035 BP 423 BP 503 BP 682 New BP 1027 BP 450 BP 463 BP 411 BP 288 BP 1028 BP 289 BP 510 BP 399 BP 464 BP 292 BP 553
332

Nitrazepam Assay Standard Controlled Substance Nitrofurfural diacetate 3-Nitroso-3-azabicyclo[3.3.O]octane Noradrenaline (norepinephrine) acid tartrate Norethisterone Assay Standard Norethisterone acetate Assay Standard Norfloxacin Assay Standard Norgestrel Nortriptyline hydrochloride Assay Standard Omeprazole Assay Standard Ondansetron hydrochloride dihydrate Assay Standard Ondansetron impurity standard Ondansetron for TLC system suitability Orciprenaline sulfate Oxibendazole Oxybuprocaine hydrochloride Assay Standard Oxybutynin hydrochloride Assay Standard Oxyclozanide Oxytetracycline Assay Standard Pancuronium bromide Assay Standard Paeoniflorin Assay Standard Papaverine hydrochloride Assay Standard Paracetamol Assay Standard Paroxetine hydrochloride hemihydrate Assay Standard Paroxetine impurity standard Pentagastrin Perindopril Erbumine Assay Standard Perindopril impurity standard Perphenazine Assay Standard Pethidine hydrochloride Assay Standard Controlled Substance Phenobarbital Assay Standard Controlled Substance Phenoxymethylpenicillin potassium Assay Standard Phentolamine mesilate Phenylcyclohexylglycolic acid Phenylephrine Hydrochloride Assay Standard 1-Phenyl-3-pyrrolidinopropan-1-one hydrochloride Phytomenadione Assay Standard Pilocarpine nitrate Assay Standard Pimozide Assay Standard Piperacillin Assay Standard 3-Piperidylpropiophenone hydrochloride Piroxicam Assay Standard Pizotifen malate Assay Standard Poldine metisulfate Assay Standard Polymyxin B Sulfate Polythiazide Assay Standard Potassium trichloroammineplatinate Prazosin hydrochloride Assay Standard Prednisolone Assay Standard Prednisolone sodium phosphate Assay Standard Prednisone Assay Standard
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 50 mg 0.1 mL 100 mg 50 mg 100 mg 100 mg 100 mg 200 mg 100 mg 100 mg 25 mg 25 mg 100 mg 25 mg 100 mg 100 mg 200 mg 100 mg 25 mg 20 mg 100 mg 100 mg 200 mg 25 mg 0.1 mg 100 mg 25 mg 100 mg 100 mg 100 mg 500 mg 50 mg 25 mg 100 mg 50 mg 0.25 mL 200 mg 100 mg 100 mg 50 mg 100 mg 50 mg 100 mg 100 mg 100 mg 25 mg 100 mg 100 mg 100 mg 250 mg
Edition 2012/2013

British Pharmacopoeia
Code Product Unit

BP 497 BP 293 BP 295 BP 638 BP 493 BP 494 BP 296 BP 449 BP 297 BP 412 BP 505 New BP 1031 New BP 1032 BP 698 BP 868 BP 413 BP 717 BP 906 New BP 1033 BP 458 BP 863 BP 862 BP 751 BP 754 BP 471 BP 593 BP 592 BP 459 BP 400 BP 586 BP 451 BP 712 BP 852 BP 704 BP 302 BP 705 New BP 883 New BP 897 New BP 898 BP 739 BP 750 BP 453 BP 490 BP 452 BP 498 BP 818 BP 312 BP 310 BP 314 BP 779

Prilocaine hydrochloride Assay Standard Primidone Assay Standard Procaine benzylpenicillin Assay Standard Prochlorperazine maleate Assay Standard Prochlorperazine mesilate Assay Standard Prochlorperazine sulphoxide Procyclidine hydrochloride Assay Standard Progesterone Assay Standard Proguanil hydrochloride Assay Standard Promethazine hydrochloride Assay Standard Promethazine sulphoxide Propofol Assay Standard Propofol Impurity J Propofol dimer Propylene glycol Assay Standard Pseudoephedrine hydrochloride Assay Standard Drug Precursor Pseudomorphine trihydrate Pyrazinamide Assay Standard Pyridostigmine Bromide Pyridoxine hydrochloride Assay Standard Quinidine sulfate Quinine sulfate Ramipril Assay Standard Ramipril Impurity K Ramipril diketopiperazine acid Ranitidine hydrochloride Assay Standard Ribavirin Assay Standard Ribavirin impurity standard Riboflavin sodium phosphate Rifampicin N-oxide Ritodrine hydrochloride Assay Standard Salbutamol Assay Standard Salbutamol aldehyde impurity Salbutamol Impurity B Salbutamol ketone impurity Salbutamol sulphate Assay Standard Selegiline hydrochloride Assay Standard Sertraline hydrochloride Assay Standard Sertraline hydrochloride impurity standard Sertraline hydrochloride cis-isomer Simvastatin Assay Standard Sodium alginate Sodium nitroprusside Assay Standard Sodium picosulfate Assay Standard Sodium valproate Assay Standard Sotalol hydrochloride Sucrose Assay Standard Sulfadiazine Assay Standard Sulfadoxine Assay Standard Sulfamethoxazole Assay Standard Sulfasalazine Assay Standard

100 mg 100 mg 100 mg 100 mg 100 mg 25 mg 100 mg 50 mg 100 mg 100 mg 25 mg 1 mL 0.05 mL 25 mg 100 mg 100 mg 25 mg 100 mg 50 mg 100 mg 300 mg 300 mg 100 mg 25 mg 100 mg 100 mg 50 mg 50 mg 25 mg 200 mg 100 mg 25 mg 10 mg 25 mg 100 mg 100 mg 100 mg 20 mg 20 mg 100 mg 200 mg 200 mg 100 mg 500 mg 100 mg 1000 mg 100 mg 100 mg 100 mg 250 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

333

British Pharmacopoeia
Code Product Unit

BP 679 BP 745 BP 876 BP 877 BP 455 BP 708 BP 709 BP 318 New BP 1045 BP 650 BP 319 BP 321 BP 322 BP 702 BP 480 BP 327 BP 414 BP 495 BP 331 BP 332 BP 848 BP 849 New BP 1079 New BP 1080 BP 645 BP 687 BP 878 BP 333 BP 882 BP 744 New BP 893 BP 734 BP 544 BP 590 BP 591 BP 338 BP 339 BP 680 BP 340 BP 341 BP 555 BP 034 BP 344 BP 346 BP 347 BP 349 BP 350 BP 706 BP 563 BP 564 BP 672
334

Sulpiride Assay Standard Sumatriptan impurity standard Tamsulosin hydrochloride Assay Standard Tamsulosin hydrochloride impurity standard Temazepam Assay Standard Controlled Substance Tenoxicam Assay Standard Tenoxicam degradation impurity standard Terbutaline sulfate Assay Standard Terbutaline Impurity C Terfenadine Assay Standard Testosterone decanoate Controlled Substance Testosterone isocaproate Controlled Substance Testosterone phenylpropionate Assay Standard Controlled Substance Testosterone propionate Assay Standard Controlled Substance Tetracycline hydrochloride Assay Standard Theophylline Assay Standard Thiamine mononitrate Assay Standard Thioridazine Assay Standard Thiotepa Assay Standard 2-Thymoxyethyldimethylamine hydrochloride Tibolone Assay Standard Tibolone impurity standard Ticarcillin Impurity B Ticarcillin Impurity C Tioconazole Assay Standard Tioconazole impurity standard Tioguanine Assay Standard Tobramycin alpha-Tocopherol Assay Standard Tramadol hydrochloride Tramadol Impurity A Tranexamic acid impurity standard Transplatin Trazodone hydrochloride Assay Standard Trazodone hydrochloride impurity standard Triamcinolone Assay Standard Triamcinolone acetonide Assay Standard Triamcinolone hexacetonide Assay Standard Triamterene Assay Standard 3,5,6-Trichloro-2-hydroxybenzoic acid 2-Trifluoromethylthioxanthone Trihexyphenidyl hydrochloride Assay Standard Trimethoprim Assay Standard z-Triprolidine hydrochloride Triprolidine hydrochloride Tylosin Urea Assay Standard Ursodeoxycholic acid Assay Standard Vigabatrin Assay Standard 5-Vinyl-2-pyrrolidone Warfarin Assay Standard
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 25 mg 100 mg 25 mg 100 mg 100 mg 25 mg 100 mg 15 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 25 mg 100 mg 10 mg 25 mg 25 mg 100 mg 100 mg 100 mg 100 mg 200 mg 100 mg 15 mg 25 mg 25 mg 100 mg 50 mg 100 mg 50 mg 100 mg 100 mg 50 mg 25 mg 100 mg 100 mg 50 mg 100 mg 50 mg 1g 150 mg 150 mg 25 mg 100 mg
Edition 2012/2013

British Pharmacopoeia
Code Product Unit

BP 353 BP 640 BP 803 BP 895 BP 850 BP 812 BP 599 BP 596 BP 558

Xylometazoline hydrochloride Assay Standard N,N'-bis(2,4-Xylyl)formamidine Zidovudine Assay Standard Zidovudine impurity standard Zidovudine and Lamivudine impurity standard Zopiclone Assay Standard Zuclopenthixol acetate dihydrochloride Assay Standard Zuclopenthixol decanoate dihydrochloride Assay Standard Zuclopenthixol hydrochloride Assay Standard

100 mg 25 mg 150 mg 25 mg 50 mg 100 mg 100 mg 100 mg 100 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

335

ATCC microbiology products

ATCC microbiology products


As a scientist you know the importance of using the best materials to support your quality control programme. As Europes only officially authorized distributor of ATCC cultures, LGC Standards can supply all ATCC organisms specified in the pharmacopoeia. ATCC maintains the highest standards for its biological materials, employing stringent quality control procedures to produce cultures which are well characterized and have low passage numbers. Long-term subculturing of biological materials can have adverse effects on the culture population, including genetic drift, unwanted selection, contamination, and varied cell responses. ATCC quality control cultures sold by LGC Standards are never subcultured or transferred in any way from ATCCs strains and our European stock-holding means orders are usually filled within 3 - 5 working days. So whether it is quality control strains, genomic DNA, media or growth supplements, antibiotics for selection, or a huge selection of organisms, take the time and guesswork out of ordering your microbiology supplies with authentic, high-quality ATCC materials - exclusively from LGC Standards.

British Pharmacopoeia 2012, volume IV and Addenda


Code Product Unit

BP Appendix XIV A - Biological assay of antibiotics


ATCC-6633 ATCC-4617 ATCC-9637 ATCC-10536 ATCC-10031 ATCC-10240 ATCC-9763 ATCC-6538P ATCC-9144 ATCC-9341 ATCC-12228 ATCC-607 Bacillus subtilis Bordetella bronchiseptica Escherichia coli Escherichia coli Klebsiella pneumoniae ss. pneumoniae Micrococcus luteus Saccharomyces cerevisiae Staphylococcus aureus subsp. aureus Staphylococcus aureus ss. aureus Kocuria rhizophila Staphylococcus epidermidis Mycobacterium smegmatis amp. amp. amp. amp. amp. amp. amp. amp. amp. amp. amp. amp.

BP Appendix XVI - Test for absence of Mycoplasma


ATCC-23206 ATCC-19989 ATCC-19610 ATCC-17981 ATCC-23714 ATCC-15531 ATCC-25204 ATCC-CCL-81 Acholeplasma laidlawii (Sabin) Edward and Freundt deposited as Mycoplasma laidlawii Mycoplasma fermentans; PG18 G Mycoplasma gallisepticum Mycoplasma hyorhinis Switzer Mycoplasma orale Mycoplasma pneumoniae Mycoplasma synoviae Vero cells amp. amp. amp. amp. amp. amp. amp. amp.

BP Appendix XVI A - Test for sterility


ATCC-16404 ATCC-6633 ATCC-10231 ATCC-19404 ATCC-9027 ATCC-6538 Aspergillus niger Bacillus subtilis Candida albicans Clostridium sporogenes Pseudomonas aeruginosa Staphylococcus aureus ss. aureus amp. amp. amp. amp. amp. amp.

BP Appendix XVI B - Tests for microbial contamination


ATCC-6633 ATCC-2091 ATCC-10231 ATCC-13124 ATCC-11437 ATCC-19404
336

Bacillus subtilis Candida albicans Candida albicans Clostridium perfringens Clostridium sporogenes Clostridium sporogenes
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

amp. amp. amp. amp. amp. amp.


Edition 2012/2013

ATCC microbiology products


Code Product Unit

ATCC-8739 ATCC-9027 ATCC-6538 ATCC-6538P

Escherichia coli Pseudomonas aeruginosa Staphylococcus aureus ss. aureus Staphylococcus aureus subsp. aureus

amp. amp. amp. amp.

BP Appendix XVI C - Efficacy of antimicrobial preservation


ATCC-16404 ATCC-10231 ATCC-8739 ATCC-9027 ATCC-6538 Aspergillus niger Candida albicans Escherichia coli Pseudomonas aeruginosa Staphylococcus aureus ss. aureus amp. amp. amp. amp. amp.

BP Appendix XVIII - Methods of sterilization


ATCC-27142** ATCC-7953** ATCC-9372** ATCC-19146 Bacillus pumilus Bacillus stearothermophilus Bacillus subtilis Brevendimonas diminuta (as Pseudomonas diminuta) amp. amp. amp. amp.

BP Appendix XVI (Vet) 3 - Test for absence of mycoplasmas


ATCC-23206 ATCC-19610 ATCC-17981 ATCC-23714 ATCC-25204 ATCC-CCL-81 Acholeplasma laidlawii (Sabin) Edward and Freundt deposited as Mycoplasma laidlawii Mycoplasma gallisepticum Mycoplasma hyorhinis Switzer Mycoplasma orale Mycoplasma synoviae Vero cells ** = Alternative strain All care has been taken in compiling catalogue numbers, however users should consult the Pharmacopoeia directly to confirm the testing requirements and recommended organisms before ordering or undertaking the testing procedures as described in the Pharmacopoeia. amp. amp. amp. amp. amp. amp.

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

337

Pharmacope Franaise

Pharmacope Franaise
The list of reference substances and reference spectra available from the Pharmacope Franaise (PF) are issued under the authority of the PF and are solely for use in tests and assays of the Pharmacopoeia Franaise and Pharmacopoeia Franaise (Vtrinaire). Since the beginning of July 2012 the French Pharmacopeia published the 11th edition that is enforceable since the 1st of July 2012. It replaces the previous edition that was official since 1983. The list in this catalogue is based on the PF list of May 2012. All PF CRS are available in restricted quantity and orders for multiple units will be reduced to a single unit.

Proper use
Reference substances from the PF are designed for specific applications, which are identified by a code number included in each product description. Uses other than those shown below are possible, but the user is responsible for checking the suitability of the PF CRS for any non-monograph use. 1 2 3 4 5 6 7 8 9 10 11 Identification by infrared spectrophotometry Identification by thin layer chromatography Test for related substances by thin layer chromatography Test for related substances by liquid chromatography Test for related substances by gas chromatography Assay by UV spectrophotometry by gas chromatography Assay by fluorimetry Assay by liquid chromatography Assay by gas chromatography Microbiological assay Assay by volumetric titration

Shelf life and expiry dates


French Pharmacopoeia chemical reference substances are subject to regular inspection and repeated analysis by PF scientific staff. Each PF CRS is, on receipt by the customer, fit for the intended use. The shelf life and the expiry date are not given, and PF advises that unopened vials should not be stored for a long period of time.

Products
Code Product Unit

FPC0050 FPC0071 FPC0072 FPC0141 FPC0190 FPC0210 FPC0271 FPC0600 FPC0610 FPC0892 FPC0950 FPC1222 FPC2900 FPC1560 FPC1600 FPC3300 FPC1780 FPC1785 FPC2032 FPC2034 FPC2036 FPC2044
338

Alimmazine tartrate Amodiaquine chlorhydrate Amprolium chlorhydrate (usage vtrinaire) Benzododecinium bromure Bleu patente V Butoform Chlormadinone acetate Eosine disodique Epivincamine Histamine Hysope (huile essentielle) Linalyle actate Lysine actylsalicylate Reference Spectrum Nifurtimox Oxyquinol Reference Spectrum Polytetrafluoroethylene Reference Spectrum Potassium gluconate Prasterone Strychnine sulfate (veterinary usage) Suc de papayer Sulconazole nitrate Sulfadimthoxine
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

25 mg 25 mg 25 mg 1000 mg 1000 mg 150 mg 100 mg 200 mg 50 mg 50 mg 1 mL 2 mL unit 250 mg unit unit 50 mg 300 mg 225 mg 500 mg 200 mg 100mg
Edition 2012/2013

Pharmacope Franaise
Code Product Unit

FPC2120 FPC2122 FPC2210 FPC2230 FPC2520 FPC2530

Sulfogaiacol Sulfogaiacol (exempt de gaiacol) Terpine Thiocolchicoside Vincamine Venin d'Abeille PBR

100 mg 1000 mg 1000 mg 300 mg 250 mg unit

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

339

Pharmacopoeia Helvetica

Pharmacopoeia Helvetica
Background
The range of reference substances available from the Pharmacopoeia Helvetica is issued under the authority of the Pharmacopoeia Helvetica, and is solely for use in tests and assays of the Pharmacopoeia Helvetica. The Pharmacopoeia Helvetica contains, in addition to harmonised European Pharmacopoeia monographs, a number of national monographs. Some of the national monographs require CRS described in the list below. The list in this catalogue is based on the current Pharmacopoeia Helvetica.

Products
Code Product Unit

SPC 015 SPC 160 SPC 170 SPC 190 SPC 204 SPC 210 SPC 300 SPC 335 SPC 320 SPC 340 SPC 380 SPC 455 SPC 505 SPC 515

-(2-Piperidyl)phenylessigsure Dexamfetaminsulfat Reference Spectrum Diamorphinhydrochlorid wasserfrei Reference Spectrum Drofeninhydrochlorid Ethanol 70% Reference Spectrum Ethanol with 2 % Ketone Reference Spectrum Methacholinchlorid Reference Spectrum Methylphenidathydrochlorid Reference Spectrum Moclobemid Reference Spectrum 2-Naphthol Reference Spectrum Oxychinolinsulfat Reference Spectrum Saponin Terpinhydrat Reference Spectrum Thiethylperazinhydrogenmaleat

50 mg unit unit 1g unit unit unit unit unit unit unit 500 mg unit 200 mg

340

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

International Pharmacopeia

International Pharmacopeia
Background
The World Health Organization (WHO) as a specialised agency of the United Nations with a primary responsibility for international health matters and public health, is the issuing body of the substances described in the International Pharmacopoeia. Progress towards better health requires international cooperation in the establishment of international standards for biological substances and pharmaceuticals. The WHO has therefore authorised the establishment and maintenance of a number of reference collections. Two are of particular interest to analysts involved in pharmaceutical and clinical measurement sciences: the collections of international biological reference substances and international chemical reference substances.

International biological reference substances


The range of biological reference substances was established to provide a means of ensuring International uniformity in the designation of the potency, activity or specificity of preparations that are used in the prevention, treatment or diagnosis of human or animal diseases, and for which chemical and physical assay terms are inappropriate. WHO biological reference substances are needed for certain antibiotic and hormone assays described in a number of pharmacopoeia. You find the WHO antibiotic standards in the European Pharmacopoeia section of this catalogue. They can be ordered conveniently from LGC Standards.

International chemical reference substances


International chemical reference substances are established upon the advice of the WHO expert committee on specifications for pharmaceutical preparations. They are intended for use in physical and chemical tests and assays described in the specifications for quality control published in the International Pharmacopoeia (IP CRS), or as proposed in draft monographs. The list in this catalogue is based on the current WHO information.

Proper use
Whilst the primary application of ICRS is in physical and chemical tests and assays as described in the International Pharmacopoeia, ICRS do have applications in other aspects of pharmaceutical analysis where a certificate of purity is required.

Documentation
Directions for use and analytical data are provided in certificates distributed with the ICRS. The certificates show how the identity and purity of the material was confirmed, and in many cases demonstrate traceability to another PRM. This information fulfills most of the requirements of a Certification Report as defined by the ISO Guides on the preparation and use of Certified Reference Materials.

Shelf life and expiry dates


International Pharmacopoeia chemical reference substances are subject to regular inspection and repeated analysis by the WHO Collaborating Centre. Each ICRS is, on receipt by the customer, suitable for the intended use. Shelf life and expiry dates are not given, and IP advises that once opened, vials should not be stored for long periods of time. Only current lots are supplied by IP. For this reason users are advised to order only as required. Once opened IP can no longer guarantee the stability of the material and any of the ICRS not used should be disposed of.

Controlled substances
For information on ordering please contact LGC Standards.

Products
Code Product Unit

ICRS1422 ICRS1552 ICRS0201 ICRS0202 ICRS0204

Abacavir sulfate Abacavir sulfate for system suitability Acetanilide (116C) Melting Point Standard Acetazolamide Allopurinol

100 mg 10 mg 1g 100 mg 100 mg

Edition 2012/2013

Looking for impurity reference standard with CofAs? See our LGC impurity chapter from page 11 on.

341

International Pharmacopeia
Code Product Unit

ICRS0206 ICRS0191 ICRS0194 ICRS0193 ICRS0208 ICRS0209 ICRS1426 ICRS0210 ICRS0211 ICRS0212 ICRS0213 ICRS0214 ICRS1408 ICRS1407 ICRS1410 ICRS1409 ICRS0215 ICRS0216 ICRS0218 ICRS0221 ICRS0222 ICRS0225 ICRS0226 ICRS0227 ICRS0228 ICRS0229 ICRS0230 ICRS0233 ICRS0234 ICRS0235 ICRS0236 ICRS0237 ICRS0238 ICRS0239 ICRS0240 ICRS2132 ICRS0241 ICRS0242 ICRS0243 ICRS0199 ICRS0245 ICRS0190 ICRS0246 ICRS0247 ICRS0248 ICRS0249 ICRS0250 ICRS0252 ICRS0253 ICRS0255 ICRS0256
342

Amidotrizoic acid 2-Amino-5-nitrothiazole 3-Aminopyrazole-4-carboxamide hemisulfate 3-Amino-2,4,6-triiodobenzoic acid Amitriptyline hydrochloride Amodiaquine hydrochloride Amoxicillin trihydrate Amphotericin B Ampicillin (anhydrous) Ampicillin sodium Ampicillin trihydrate Anhydrotetracycline hydrochloride Artemether Artemotil Artenimol Artesunate Atropine sulfate Azathioprine Bacitracin zinc Benzanilide (165C) Melting Point Standard Benzil (96C) Melting Point Standard Benzylpenicillin potassium Benzylpenicillin sodium Bephenium hydroxynaphthoate Betamethasone Betamethasone sodium phosphate Betamethasone valerate Bupivacaine hydrochloride Caffeine Caffeine (237C) Melting Point Standard Calcium folinate (Leucovorin calcium) Captopril Captopril disulfide Carbamazepine Carbenicillin monosodium Carbidopa Chloramphenicol Chloramphenicol palmitate Chloramphenicol palmitate (Polymorph A) 5-Chloro-2-methylaminobenzophenone Chloroquine sulfate 2-(4-Chloro-3-sulfamoylbenzoyl)benzoic acid Chlorphenamine hydrogen maleate Chlorpromazine hydrochloride Chlortalidone Chlortetracycline hydrochloride Cimetidine Ciprofloxacin by compound A Ciprofloxacin desfluoro-compound Ciprofloxacin fluoroquinolonic acid Ciprofloxacin hydrochloride
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 25 mg 100 mg 100 mg 100 mg 200 mg 100 mg 400 mg 200 mg 200 mg 200 mg 25 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 200 mg 1g 1g 200 mg 200 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 1g 100 mg 100 mg 25 mg 100 mg 200 mg 100 mg 200 mg 1g 200 mg 100 mg 200 mg 50 mg 100 mg 100 mg 100 mg 200 mg 100 mg 20 mg 20 mg 20 mg 400 mg
Edition 2012/2013

International Pharmacopeia
Code Product Unit

ICRS0258 ICRS0259 ICRS0260 ICRS0261 ICRS2130 ICRS0263 ICRS0265 ICRS0266 ICRS0267 ICRS0268 ICRS0270 ICRS0282 ICRS0283 ICRS0285 ICRS1413 ICRS1414 ICRS0286 ICRS0287 ICRS0288 ICRS0289 ICRS0290 ICRS0292 ICRS1411 ICRS0294 ICRS0197 ICRS0198 ICRS0295 ICRS0296 ICRS0297 ICRS0298 ICRS0299 ICRS0300 New ICRS46470 ICRS0301 ICRS0302 ICRS0304 ICRS0305 ICRS0306 ICRS0307 ICRS0309 ICRS0310 ICRS0311 ICRS0312 ICRS0315 ICRS0316 ICRS0195 ICRS0355 ICRS0318 ICRS0319 ICRS0322 ICRS0323
Edition 2012/2013

Cisplatin Clomifene citrate Zuclomifene (Clomifene citrate Z-isomer) Cloxacillin sodium Colchicine Cortisone acetate Dapsone Desoxycortone acetate Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Diazoxide Dicloxacillin sodium Dicoumarol Didanosine Didanosine for system suitability Dicyanodiamide (210C) Melting Point Standard Diethylcarbamazine dihydrogen citrate Digitoxin Digoxin Dopamine hydrochloride Doxorubicin hydrochloride Efavirenz Emetine hydrochloride 4-Epianhydrotetracycline hydrochloride 4-Epitetracycline hydrochloride Ergocalciferol (Vitamin D2) Ergometrine hydrogen maleate Drug Precursor Ergotamine tartrate Drug Precursor Erythromycin Erythromycin B Erythromycin C Erythromycin ethylsuccinate Estradiol benzoate Estrone Ethambutol hydrochloride Ethinylestradiol Ethisterone Ethosuximide Flucloxacillin sodium Flucytosine Fludrocortisone acetate Fluorouracil Fluphenazine hydrochloride Folic acid 3-Formylrifamycin Framycetin sulfate (Neomycin B sulfate) Furosemide Gentamicin sulfate Griseofulvin Haloperidol
Looking for impurity reference standard with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 100 mg 50 mg 200 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 200 mg 100 mg 10 mg 10 mg 1g 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 25 mg 25 mg 500 mg 50 mg 50 mg 250 mg 25 mg 25 mg 10 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 200 mg 100 mg 200 mg 100 mg 100 mg 100 mg 200 mg 200 mg 100 mg 100 mg 200 mg 100 mg
343

International Pharmacopeia
Code Product Unit

ICRS0324 ICRS0325 ICRS0326 ICRS0327 ICRS0188 ICRS0189 ICRS0328 ICRS0329 ICRS1415 ICRS0330 ICRS0331 ICRS1416 ICRS1553 ICRS0333 ICRS0334 ICRS0335 ICRS0336 ICRS0337 ICRS0338 ICRS0339 ICRS0340 ICRS2125 ICRS39627 ICRS0341 ICRS0454 ICRS1549 ICRS0345 ICRS0346 ICRS0347 ICRS0348 ICRS0350 ICRS0351 ICRS2128 ICRS1417 ICRS0356 ICRS1412 ICRS1423 ICRS0357 ICRS0358 New ICRS0360 ICRS0366 ICRS0367 ICRS2123 ICRS0369 ICRS0371 ICRS0372 ICRS0373 ICRS0374 ICRS0376 ICRS0377 ICRS0378
344

Hydrochlorothiazide Hydrocortisone Hydrocortisone acetate Hydrocortisone sodium succinate (-)-3-(4-Hydroxy-3-methoxyphenyl)-2-hydrazino-2-methylalanine (3-o-Methylcarbidopa) (-)-3-(4-Hydroxy-3-methoxyphenyl)-2-methylalanine (3-o-Methylmethyldopa) Ibuprofen Imipramine hydrochloride Indinavir Indometacin Isoniazid Lamivudine Lamivudine for system suitability Lanatoside C Levodopa Levonorgestrel Levothyroxine sodium Lidocaine Lidocaine hydrochloride Liothyronine sodium Loperamide hydrochloride Lumefantrine Lumefantrine for system suitability Mebendazole Medroxyprogesterone acetate DL-Methionine Methotrexate Methyldopa Methyltestosterone Meticillin sodium Metronidazole Nafcillin sodium Naloxone hydrochloride Nelfinavir mesilate Neostigmine metilsulfate Nevirapine anhydrous Nevirapine impurity B Nicotinamide Nicotinic acid Niridazole Norethisterone Norethisterone acetate Norethisterone enantate Nystatin Oubain Oxacillin sodium Oxytetracycline dihydrate Oxytetracycline hydrochloride Papaverine hydrochloride Paracetamol Paromomycin sulfate
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 100 mg 100 mg 200 mg 25 mg 25 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 10 mg 100 mg 100 mg 200 mg 50 mg 100 mg 100 mg 50 mg 100 mg 100 mg 10 mg 200 mg 100 mg 100 mg 100 mg 100 mg 100 mg 200 mg 100 mg 200 mg 100 mg 100 mg 100 mg 100 mg 10 mg 100 mg 100 mg 200 mg 100 mg 100 mg 50 mg 200 mg 100 mg 200 mg 200 mg 200 mg 100 mg 100 mg 75 mg
Edition 2012/2013

International Pharmacopeia
Code Product Unit

ICRS0380 ICRS0382 ICRS0383 ICRS0384 ICRS0385 ICRS0387 ICRS0388 ICRS0389 ICRS0390 ICRS0391 ICRS0392 ICRS0393 ICRS0394 ICRS0395 ICRS0396 ICRS0397 ICRS0398 ICRS0399 ICRS0400 ICRS0402 ICRS0403 ICRS0404 ICRS1424 ICRS0405 New ICRS47051 ICRS0406 ICRS0408 ICRS0409 ICRS0410 ICRS1421 ICRS1418 ICRS0411 ICRS0412 ICRS0413 ICRS0415 ICRS1419 ICRS0416 ICRS0417 ICRS0419 ICRS0420 ICRS0421 ICRS0422 ICRS0423 ICRS0424 ICRS0425 ICRS0426 ICRS0427 ICRS0428 ICRS0429 ICRS0430 ICRS0196
Edition 2012/2013

Phenacetin (136C) Melting Point Standard Phenolphthalein (263C) Melting Point Standard Phenoxymethylpenicillin Phenoxymethylpenicillin calcium Phenoxymethylpenicillin potassium Phenytoin Piperazine adipate Piperazine citrate Praziquantel Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone sodium phosphate Prednisone Prednisone acetate Probenecid Procaine hydrochloride Procarbazine hydrochloride Progesterone Propanolol hydrochlorid Propylthiouracil Pyrantel embonate (Pyrantel pamoate) Pyrazinamide Pyridostigmine bromide Pyrimethamine Reserpine Riboflavin Rifampicin Rifampicin quinone Ritonavir Saquinavir mesilate Saccharin (229C) Melting Point Standard Sodium amidotrizoate Sodium cromoglicate Spectinomycin hydrochloride Stavudine Streptomycin sulfate Sulfacetamide Sulfamethoxazole Sulfamethoxypyridazine Sulfanilamide Sulfanilamide (166C) Melting Point Standard Sulfapyridine (193C) Melting Point Standard Sulfasalazine Tamoxifen citrate Tamoxifen E-isomer Testosterone enantate Testosterone propionate Tetracycline hydrochloride Thioacetazone 4,4'-Thiodianiline
Looking for impurity reference standard with CofAs? See our LGC impurity chapter from page 11 on.

1g 1g 200 mg 200 mg 200 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 200 mg 200 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 500 mg 100 mg 100 mg 250 mg 100 mg 250 mg 300 mg 200 mg 100 mg 100 mg 1g 100 mg 100 mg 200 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 1g 4g 100 mg 100 mg 10 mg 200 mg 100 mg 200 mg 100 mg 50 mg
345

International Pharmacopeia
Code Product Unit

ICRS0431 ICRS0432 ICRS0433 ICRS0434 ICRS0435 ICRS0438 ICRS0439 ICRS1420 ICRS1554

Tolbutamide Tolnaftate Toluene-2-sulfonamide Trimethadione Trimethoprim Vanillin (83C) Melting Point Standard Warfarin Zidovudine Zidovudine impurity B

100 mg 100 mg 100 mg 200 mg 100 mg 1g 100 mg 100 mg 10 mg

346

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

VHG-LCDN-100 VHG-LPBN-100 VHG-LASN-100 VHG-LHGN-100 VHG-LCRN-100

Cadmium Lead Arsenic Mercury Chromium

10g/mL* 10g/mL* 10g/mL* 10g/mL* 10g/mL*

VHG-LMONF-100 VHG-LNIN-100 VHG-LVN-100 VHG-LCUN-100

Molybdenium Nickel Vanadium Copper

10g/mL* 10g/mL* 10g/mL* 10g/mL*

United States Pharmacopeia and National Formulary

United States Pharmacopeia and National Formulary


Background
USP reference standards are highly purified substances that are provided specifically for use in the official test methods of the United States Pharmacopeia and National Formulary. When used as a part of the relevant official monograph they provide the means to verify the compliance of a material with USP-NF standards for identity, concentration, quality and purity. Official USP and NF Reference Standards are made available as required for use in assays and tests appearing in the current edition of the USP-NF. They are collaboratively tested and approved for such use by the USP Reference Standards Committee and released only under the authority of the USP Board of Trustees. The range of USP reference standards includes: 1. 2. 3. 4. Official USP and NF Reference Standards. Former USP and NF Reference Standards, not required in the current USP or NF, but for which sufficient demand remains. Food Chemicals Codex (FCC) reference standards, specified in the current edition of the Food Chemicals Codex. Authentic Substances (AS), which are highly purified samples of chemicals, that are collaboratively tested and made available as a service to analysts.

The list in this catalogue includes all amendments and new products made official by USP to July 2011.

Production and certification


The development of USP reference standards is a multi-step process that makes much use of voluntary cooperation from the pharmaceutical industry, government agencies including the United States Food and Drug Administration (FDA), and both USP in-house scientific staff and the members of the Committee of Revision. The following steps are adhered to, and the process takes from one to two years. 1. 2. 3. 4. Preparation and purification of candidate material. Testing and characterisation through a collaborative study (ring test). Initial scientific and statistical review. Further analytical work is often required, and at this stage it is possible that the candidate material is rejected and the procedure restarted. Preparation of a USP Reference Standards Committee letter, containing the data from the collaborative study for use by the Reference Standards Committee. This document is USPs internal equivalent of a certification report. Approval of the document must be unanimous or further analytical work will be requested, or the whole cycle restarted. Packaging and final quality control testing for homogeneity, integrity of the package, etc.

5.

USP generally does not provide certificates of analysis for USP reference standards (as outlined in their Document Disclosure Policy). USP reference standards are solely for use in the official tests and methods of the current official compendia. When handled in accordance with labelled instructions and monographs, they are considered as a value of 100.0% for compendial purposes, unless otherwise stated. In response to requests from LGC Standards, USP began listing the labelled purity values for reference standards and authentic substances. Each value is followed by a code to indicate the basis of the assignment. For example, a reference standard with a labelled purity of 0.998 mg/mg calculated on the "as is" basis, will be listed as "0.998 mg/mg (ai)". From now on, the values will be included for new lots released since January 1, 2004 and they will be included for all lots as they are released in the future. Below is a list of the basis codes and their meaning: (ai) (dr) (an) (fb) as is dried anhydrous free base.

It must be noted that any other use of a USP reference standard in non-official procedures becomes the responsibility of the user.

Proper use
A full description of the background to, proper use of and lot control procedures for USP-NF reference standards is given in General Chapter <11> of the current USP-NF publication. Analysts are strongly advised to review this section on a regular basis. More information on USP publications and subscriptions is given in the Publications and subscriptions section of this catalogue.

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

349

United States Pharmacopeia and National Formulary Shelf life, expiry dates and size unit
USP reference standards are not labeled with an expiry date. The official lot number system provides greater flexibility than a simple expiry date system. USP reference standards stocks are regularly and rigorously checked. Under normal circumstances a new lot is made official and held for future use, before the old lot is sold out. The old lot remains official for a period of time so that in-house reference substances can be recertified against the out-going and incoming lots and also to prevent unnecessary waste. Please note, that new lots can have different unit sizes, especially with pharmacopoeial reference standards, and LGC Standards is not responsible for such cases. If the unit size of a new batch changes, LGC Standards will provide this information to customers in new lot lists. It is the responsibility of each analyst to ensure that his particular supply of USP reference substance is current. As your supplier of choice, LGC Standards can provide lists of current lot numbers of USP reference standards, so call us to receive these today. Please take this opportunity to subscribe to this free service by contacting your local LGC Standards office.

Validation of secondary standards against USP reference substances


All secondary in-house working standards have to be compared against the corresponding USP reference standard. Please make sure that the secondary material is used only for the same official purposes for which the primary pharmacopoeial material also was designed.

Replacement lots and back orders


Because of the rigorous nature of the approval process and the time taken, it is not always possible for USP to have a new lot available before an existing lot is depleted. USP provides LGC Standards with regular information about the projected availability of back-ordered USP RS. Please contact LGC Standards for any enquiry.

Storage conditions
The USP-NF states that generally, reference standards should be stored in their original sealed containers away from heat and protected from light. Avoid humid storage areas in particular. In addition, the USP-NF recommends in its General Notices, that where no specific storage directions or limitations are provided in the individual monograph, it is to be understood that conditions of storage include protection from moisture, freezing and excessive heat.

Controlled Substances
The USP list contains substances subject to Controlled Substance Regulations Schedules I, II, III, IV and V. Special ordering procedures apply, please contact LGC Standards for details and costs.

Restricted Reference Standards


The United States Government restricts the export of chemicals appearing on the US Munition list, the Commerce Control list or in the Chemical Weapons Convention Annex on chemicals. Listed below are USP reference standards that are now currently restricted and may not be exported to any country outside the U.S.A. USP1106001 Chlorambucil USP1157002 Cyclophosphamide USP1376505 Mechlorethamine Hydrochloride USP1379300 Melphalan Hydrochloride USP1706009 Uracil Mustard

Products
Code Product Unit

USP1000408 USP1000419 USP1000420 USP1000441 USP1000452

Abacavir Sulfate Abacavir Sulfate Racemic 4-[2-amino-6-(cyclopropylamino)9H-purin-9yl]-2-cyclopentene-1-methanol sulfate (2:1) Abacavir Related Compound A [4-(2,6-diamino-9H-purin-9-yl)cyclopent-2-enyl]methanol Abacavir Related Compound B [4-(2,5-diamino-6-chloropyrimidin-4-ylamino)cyclopent-2-enyl]methanol Abacavir Related Compound C [(1S,4R)-4-(2-amino-6-chloro-9H-purin-9-yl)cyclopent-2-enyl]methanol HCl
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

200 mg 20 mg 20 mg 20 mg 20 mg

350

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1000485 USP1000496 USP1000500 USP1000601 USP1000612 USP1001003 USP1001502 USP1002505 USP1003009 USP1003010 New USP1003027 New USP1003031 New USP1003042 New USP1003100 USP1004001 USP1005004 USP1005706 USP1006007 USP1006506 USP1006801 USP1007000 USP1008501 USP1009005 USP1612619 New USP1009479 USP1009901 USP1009923 USP1010106 USP1011007 USP1011018 USP1011029 USP1012032 USP1012065 USP1012076 New USP1011709 New USP1011710 New USP1011721 New USP1011732 New USP1011743 New USP1011754 USP1012134

Abacavir Related Compounds Mixture Abacavir Stereoisomers Mixture Abacavir System Suitability Mixture Acebutolol HCl Acebutolol Related Compound A N-(3-acetyl-4-hydroxyphenyl)butanamide (AS) Acenocoumarol Acepromazine Maleate Acesulfame Potassium Acetaminophen Acetaminophen Related Compound A 4-(acetylamino)phenyl acetate Acetaminophen Related Compound B N-(4-hydroxyphenyl)propanamide Acetaminophen Related Compound C N-(2-hydroxyphenyl)acetamide Acetaminophen Related Compound D N-phenylacetamide Acetaminophen Related Compound J N-(4-chlorophenyl)acetamide Acetanilide Melting Point Standard (Approximately 114C) Acetazolamide Glacial Acetic Acid (AS) Acetohexamide Acetohydroxamic Acid Acetone Acetophenazine Maleate Acetylcholine Chloride Acetylcysteine N-Acetylneuraminic Acid 2-Acetylpyridine Acetyltributyl Citrate Acetyltriethyl Citrate N-Acetyl-L-Tyrosine Acitretin Acitretin Related Compound A (2Z,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid Acitretin Related Compound B ethyl(all-E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoate Actein Acyclovir Acyclovir Related Compound A 2-[(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl acetate Adapalene Adapalene Related Compound A Methyl 6-bromo-2-naphthoate Adapalene Related Compound B Methyl 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoate Adapalene Related Compound C 2-(adamant-1-yl)methoxybenzene Adapalene Related Compound D 4,4'-dimethoxy-3,3'-di(adamant-1-yl)biphenyl Adapalene Related Compound E 2,2'binaphthyl-6,6'-dicarboxylic acid Ademetionine Disulfate Tosylate

15 mg 15 mg 15 mg 125 mg 20 mg 200 mg 250 mg 200 mg 400 mg 15 mg 50 mg 50 mg 50 mg 50 mg 500 mg 2g 3x1.5 mL 250 mg 200 mg 3x1.5 mL 200 mg 200 mg 200 mg 200 mg 1g 500 mg 500 mg 100 mg 200 mg 20 mg 20 mg 20 mg 300 mg 50 mg 200 mg 50 mg 50 mg 25 mg 25 mg 25 mg 500 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

351

United States Pharmacopeia and National Formulary


Code Product Unit

USP1012101 USP1012123 USP1012112 USP1012178 USP1012190 USP1012214 USP1012145 USP1012203 USP1012495 USP1012509 USP1012553 New USP1012595 USP1012600 USP1012633 USP1012644 USP1012757 USP1012746 USP1012768 USP1012772 USP1012699 USP1012688 USP1012780 USP1012906 USP1012917 USP1012928 New USP1012871 USP1012848 USP1012939 USP1012950 USP1013002 USP1013024 USP1013013 USP1013035 USP1013046 USP1013068 USP1013079 USP1013057 USP1013512 USP1013523 USP1013534 USP1014005 USP1015008 USP1015019

Adenine Adenosine S-Adenosyl-L-Homocysteine 5'-Adenylic Acid Adipic Acid Agar Agigenin Agnuside Beta Alanine L-Alanine Albendazole rAlbumin Human (Recombinant Human Albumin) Albuterol Albuterol Sulfate Albuterol Related Compound A 4-[2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl]-2-methylphenol sulfate Alclometasone Dipropionate Alclometasone Dipropionate Related Compound A 11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate Alcohol Dehydrated Alcohol Alcohol Determination-Acetonitrile Alcohol Determination-Alcohol Alendronate Sodium Alfentanil HCl Controlled Substance CII Alfuzosin HCl Alfuzosin System Suitability Mixture Alfuzosin System Suitability Mixture A Alfuzosin HCl containing Impurity A, Impurity D, and Impurity E Alitame Allantoin Alliin Allopurinol Allopurinol Related Compound A 3-Amino-4-carboxamidopyrazole Hemisulfate Allopurinol Related Compound B 5-(formylamino)-1H-pyrazole-4-carboxamide Allopurinol Related Compound C 5-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4-carboxamide Allopurinol Related Compound D ethyl 5-amino-1H-pyrazole-4-carboxylate Allopurinol Related Compound E ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate Allopurinol Related Compound F ethyl-(E/Z)-3-(2-carbethoxy-2-cyanoethenyl)amino-1H-pyrazole-4-carboxylate S-Allyl-L-Cysteine Almotriptan Malate Almotriptan Related Compound A {3-[2-(Dimethylamino)ethyl]-5-[)pyrrolidine-1-yl)sulfonylmethyl]-1H-indol-1-yl}methanol Almotriptan System Suitability Mixture of Almotriptan Malate and Almotriptan Monomethyl Analog Alphaprodine HCl Controlled Substance CII Alprazolam Controlled Substance CIV Alprazolam Related Compound A 2-(2-acetylhydrazino)-7-chloro-5-phenyl-3H-1,4-benzodiazepine
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

200 mg 200 mg 50 mg 500 mg 100 mg 500 mg 25 mg 25 mg 100 mg 200 mg 200 mg 4.92 mg 200 mg 200 mg 25 mg 300 mg 20 mg 5x1.2 mL 5x1.2 mL 5x5 mL 5x5 mL 200 mg 500 mg 150 mg 15 mg 25 mg 250 mg 200 mg 25 mg 250 mg 25 mg 25 mg 25 mg 35 mg 25 mg 25 mg 25 mg 200 mg 20 mg 20 mg 250 mg 200 mg 30 mg

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Code Product Unit

USP1016000 USP1017105 USP1017364 USP1017502 USP1018505 USP1019202 USP1019406 USP1019417 USP1019428 USP1019508 USP1019701 USP1019712 USP1019756 USP1019767 USP1019803 USP1020008 New USP1020023 USP1021000 USP1021204 USP1022808 USP1025205 USP1025307 USP1025351 USP1025602 USP1025806 USP1025908 USP1026004 USP1026401 USP1026605 USP1027007 USP1027302 USP1027346 USP1027357 USP1027380 USP1028000 USP1029002 USP1029013 USP1029024 USP1029501 USP1029512

Alprostadil Altretamine Aluminum Sulfate (AS) Dried Aluminum Hydroxide Gel Amantadine HCl Amcinonide Amifostine Amifostine Disulfide Amifostine Thiol 2-[(3-aminopropyl)amino]ethanethiol, dihydrochloride Amikacin Amiloride HCl Amiloride Related Compound A Methyl 3,5-diamino-6-chloropyrazine-2-carboxylate (AS) Aminobenzoate Potassium Aminobenzoate Sodium Aminobenzoic Acid p-aminobenzoic acid Aminobutanol Gamma-Aminobutyric Acid Aminocaproic Acid 4-Aminophenol 2-Amino-5-chlorobenzophenone Aminoglutethimide m-Aminoglutethimide Aminohippuric Acid Amino Methacrylate Copolymer 2-[3-Amino-5-(n-methylacetamido)-2,4,6-triiodobenzamido]-2-deoxy-d-glucose Aminopentamide Sulfate m-Aminophenol Aminosalicylic Acid 3-Amino-2,4,6-triiodobenzoic Acid 5-Amino-2,4,6-triiodo-N-methylisophthalamic Acid Amiodarone HCl Amiodarone Related Compound D (2-butylbenzofuran-3-yl)(4-hydroxy-3,5-diiodophenyl)methanone Amiodarone Related Compound E (2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone Amiodarone Related Compound H 2-chloro-N,N-diethylethanamine HCl Amitraz Amitriptyline HCl Amitriptyline Related Compound A Dibenzosuberone Amitriptyline Related Compound B 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d]-cyclohepten-5-ol Amlodipine Besylate Amlodipine Related Compound A 3-Ethyl,5-methyl [2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-3,5pyridinedicarboxylate]fumarate Ammonio Methacrylate Copolymer Type A Ammonio Methacrylate Copolymer Type B Ammonium Carbonate (AS) Ammonium Chloride

25 mg 500 mg 2g 200 mg 200 mg 200 mg 150 mg 100 mg 50 mg 300 mg 500 mg 30 mg 200 mg 200 mg 200 mg 500 mg 50 mg 200 mg 100 mg 25 mg 200 mg 100 mg 200 mg 1.5 g 25 mg 200 mg 300 mg 125 mg 50 mg 50 mg 200 mg 20 mg 25 mg 20 mg 200 mg 200 mg 25 mg 25 mg 350 mg 15 mg

USP1029909 USP1029910 USP1029942 USP1029953

500 mg 500 mg 2g 200 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

353

United States Pharmacopeia and National Formulary


Code Product Unit

New USP1029929 USP1029986 USP1030001 USP1031004 USP1031401 USP1031503 USP1031514 USP1031525 USP1031536

Ammonium Glycyrrhizate Ammonium Phosphate Dibasic (AS) Amobarbital Controlled Substance CII Amodiaquine HCl Amoxapine Amoxicillin Amoxicillin Related Compound A (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Amoxicillin Related Compound B L-amoxicillin Amoxicillin Related Compound C (4S)-2-[5-(4-hydroxyphenyl)-3,6-dioxopiperazin-2-yl]5,5-dimethylthiazolidine-4-carboxylic acid Amoxicillin Related Compound D (4S)-2-{[(R)-2-amino-2-(4-hydroxyphenyl)acetamido](carboxy)methyl}-5,5dimethylthiazolidine-4-carboxylic acid, monosodium salt Amoxicillin Related Compounds D and E Mixture Amoxicillin Related Compound F 3-(4-Hydroxyphenyl)pyrazin-2-ol; phenylpyrazinediol Amoxicillin Related Compound G (2S,5R,6R)-6-{(R)-2-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-2-(4hydroxyphenyl)acetamido}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2carboxylic acid; D-hydroxyphenylglycylamoxicillin Amoxicillin Related Compound I (R)-2-Amino-2-(4-hydroxyphenyl)acetic acid Amoxicillin Related Compound J Mixture of amoxicillin and amoxicillin related compound J (open ring dimer) Amphotericin B Ampicillin Ampicillin Sodium Ampicillin Trihydrate Amprolium Amrinone (Inamrinone) Amrinone Related Compound A 5-carboxamide[3,4'-bipyridin]-6(1H)-one (Inamrinone Related Compound A) Amrinone Related Compound B N-(1,6-dihydro-6-oxo-(3,4'-bipyridine)-5-yl)-2-hydroxypropanamide (Inamrinone Related Compound B) Amrinone Related Compound C 1,6-dihydro-6-oxo-(3,4'-bipyridine)-5-carbonitrile (Inamrinone Related Compound C) Anagrelide HCl Anagrelide Related Compound A ethyl 2-(6-amino-2,3-dichlorobenzylamino)acetate Anagrelide Related Compound B (2-amino-5,6-dichloroquinazolin-3(4H)-yl)acetic acid Anagrelide Related Compound C Ethyl 2-(5,6-dichloro-2-imino-1,2-dihydroquinazolin-3(4H)-yl)acetate Anastrozole Anastrozole Related Compound A 2,2'-(5-methyl-1,3-phenylene)bis(2-methylpropanenitrile) Andrographolide Powdered Andrographis Extract Anecortave Acetate Anecortave Acetate Related Compound A 9(11)-dehydrocortisol Anethole (AS) 1,6-Anhydro-D-glucose Anileridine HCl Controlled Substance CII
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 1g 200 mg 500 mg 200 mg 200 mg 15 mg 15 mg 15 mg

USP1031547

50 mg

USP1031558 USP1031569 USP1031570

15 mg 15 mg 15 mg

USP1031591 USP1031605 USP1032007 USP1033000 USP1033203 USP1033407 USP1034002 USP1034308 USP1034320 USP1034341

15 mg 15 mg 125 mg 200 mg 125 mg 200 mg 200 mg 500 mg 100 mg 100 mg

USP1034363 USP1034738 USP1034749 USP1034750 USP1034771 USP1034807 USP1034818 USP1034862 USP1034873 USP1034909 USP1034910 USP1035005 USP1035300 USP1036008
354

50 mg 100 mg 25 mg 25 mg 25 mg 200 mg 20 mg 50 mg 500 mg 200 mg 20 mg 2 mL 50 mg 250 mg


Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1036507 USP1037011 USP1038003 USP1039006 New USP1039152 USP1040005 New USP1040016 USP1040683 USP1040708 New USP1040854 USP1041008 USP1041609 USP1041904 USP1041915

3-Anilino-2-(3,4,5-trimethoxybenzyl)acrylonitrile (AS) Anisole Antazoline Phosphate Anthralin Allyl Anthranilate Antipyrine Antipyrine Related Compound A 3-methyl-1-phenyl-1H-pyrazol-5(4H)-one Apigenin Apigenin-7-glucoside Apocarotenal Beta-Apo-8'-Carotenal Apomorphine HCl Apraclonidine HCl Aprepitant Aprepitant Related Compound A 3-[[(2R,3R)-2-[(R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)-one Aprepitant Related Compound B 3-[[(2S,3R)-2-[(S)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4fluorophenyl)morpholino]methyl-1H-1,2,4-triazol-5(4H)-one L-Arabinitol L-Arginine Arginine Ethyl Ester Dihydrochloride Arginine HCl Aripirazole Aripiprazole Related Compound B 7-(4-hydroxy-butoxy)3,4-dihydroquinolin-2(1H)-one Aripiprazole Related Compound C 1-(2,3-dichlorophenyl)piperazine HCl Aripiprazole Related Compound F 4-(2,3-dichlorophenyl-1-[4-(2-oxo-1,2,3,4-tetrahydroquinolin-7-yloxy)butyl]piperazin 1-oxide Aripiprazole Related Compound G 7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}quinolin-2(1H)-one Aripiprazole Related Compound H 7-(4-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}butoxy)-3,4-dihydroquinolin-2-(1H)-one Arsanilic Acid Artemether Artemether Related Compound A (3R,5aS,6R,8aS,9R,12R,12aR)-Decahydro-10-hydroxy-3,6,9-trimethyl-3,12-epoxy-12Hpyrano[4,3-j]-1,2-benzodioxepin Artemether Related Compound B (3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-10-methoxy-3,6,9-trimethyl-3,12-epoxy12H-pyrano[4,3-j]-1,2-benzodioxepin Artesunate Articaine Articaine HCl Articaine Related Compound A Methyl 4-methyl-3-[2-propylamino) acetamido)thiophene-2-carboxylate Articaine Related Compound B 4-methyl-3-{[2-(propylamino)propanoy]amino}thiophene-2-carboxylic acid Articaine Related Compound E Methyl 3-[2-(isopropylamino)propanamido]-4-methylthiophene-2-carboxylate Ascorbic Acid (Vitamin C) Ascorbyl Palmitate (AS) Powdered Ashwagandha Extract Asiaticoside
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

25 mg 3x1.2 mL 200 mg 200 mg 5x0.5 mL 200 mg 25 mg 30 mg 30 mg 3x50 mg 250 mg 100 mg 50 mg 10 mg

USP1041926

10 mg

USP1042102 USP1042500 USP1042554 USP1042601 New USP1042634 New USP1042645 New USP1042656 New USP1042689 New USP1042690 New USP1042714 USP1042703 USP1042780 USP1042791

500 mg 200 mg 250 mg 125 mg 200 mg 25 mg 25 mg 25 mg 25 mg 25 mg 25 mg 100 mg 15 mg

USP1042805

15 mg

USP1042850 USP1042907 USP1042918 USP1042929 USP1042930 USP1042962 USP1043003 USP1043105 USP1043309 USP1043331
Edition 2012/2013

200 mg 40 mg 125 mg 40 mg 25 mg 40 mg 1g 2g 1g 30 mg
355

United States Pharmacopeia and National Formulary


Code Product Unit

USP1043502 USP1043513 USP1043706 USP1043750 USP1043728 USP1043819 USP1044006 USP1044301 USP1044403 USP1044469 USP1044470 USP1044488 USP1044491 USP1044913 USP1044516 USP1044527

Asparagine Anhydrous Asparagine Monohydrate Aspartame Aspartame Acesulfame Aspartame Related Compound A 5-Benzyl-3,6-dioxo-2-piperazineacetic Acid Aspartic Acid Aspirin Astemizole Atenolol Atomoxetine HCl Atomoxetine Related Compound A 3-(Methylamino)-1-phenylpropan-1ol Atomoxetine Related Compound B N-Methyl-3-phenyl-3-(m-tolyloxy)propan-1-amine HCl Atomoxetine Related Compound C N-methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine HCl Atomoxetine S-Isomer (S)-N-Methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine HCl Atorvastatin Calcium Atorvastatin Related Compound A Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt Atorvastatin Related Compound B 3S,5R isomer,or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt Atorvastatin Related Compound C Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptcnoic acid calcium salt Atorvastatin Related Compound D Epoxide impurity, or 3-(4-Fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2carboxylic acid phenylamide Atorvastatin Related Compound E 3S,5S enantiomer of Atorvastatin Calcium Atorvastatin Related Compound H 5-(4-Fluorophenyl)-1-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}2-isopropyl-N,4-diphenyl-1H-pyrrole-3-carboxamide Atorvastatin Related Compound I tert-Butyl 2-((4R,6R)-6-{2-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-phenylcarbamoyl)1H-pyrrol-1-yl)]ethyl}-2,2-dimetyl-1,3-dioxan-4-yl)acetate Atovaquone Atovaquone Related Compound A cis-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone Atracurium Besylate Atropine Sulfate Aurothioglucose Avobenzone Azacitidine Related Compound A 4-Amino-1,3,5-triazin-2(1H)-one Azacitidine Related Compound B 1-O-Acetyl-2,3,5-tri-O-benzoyl-Beta-D-ribofuranose Azaerythromycin A 9-Deoxo-9a-aza-9a-homoerythromycin A Azaperone Azatadine Maleate Azathioprine Azithromycin Azithromycin Identity
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

200 mg 200 mg 200 mg 200 mg 25 mg 100 mg 500 mg 200 mg 200 mg 100 mg 10 mg 10 mg 10 mg 10 mg 100 mg 20 mg

USP1044538

20 mg

USP1044549

20 mg

USP1044550

20 mg

USP1044571 USP1044582

10 mg 20 mg

USP1044593

20 mg

USP1044651 USP1044662 USP1044800 USP1045009 USP1045508 USP1045337 New USP1045539 New USP1045541 USP1045600 USP1045756 USP1045803 USP1046001 USP1046056 USP1046067
356

200 mg 25 mg 100 mg 500 mg 100 mg 500 mg 15 mg 15 mg 100 mg 200 mg 200 mg 200 mg 100 mg 75 mg
Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1046012 USP1046090 USP1046045 USP1046023 USP1046147 USP1046205 USP1046307 USP1046409 USP1047300 USP1047503 USP1048007 USP1048200 USP1048222 USP1048244 USP1048233 USP1048255 USP1048266 USP1048277 USP1048506 USP1048550 USP1048572 USP1048583 USP1048619 USP1048620

Azithromycin Identification Mixture Azithromycin N-Oxide Azithromycin Related Compound F 3'-N-demethyl-3'-N-formylazithromycin Azithromycin Related Compound H 3'-N-[[4-(acetylamino)phenyl]sulfonyl]-3'-N-demethylazithromycin Azo-Aminoglutethimide Aztreonam Aztreonam E-Isomer Open Ring Aztreonam Bacampicillin HCl Bacitracin (Susceptibility disk standard) Bacitracin Zinc Baclofen Baclofen Related Compound A 4-(4-Chlorophenyl)-2-pyrrolidinone Powdered Bacopa Extract Bacoside A3 Balsalazide Disodium Balsalazide Related Compound A (E)-5-[(p-carboxyphenyl)azo]-2-salicylic acid, disodium salt Balsalazide Related Compound B (E)-5-((m-[(2-carboxyethyl)carbamoyl]phenyl)azo)-2-salicylic acid Beclomethasone Dipropionate Behenoyl Polyoxylglycerides Bemotrizinol Bemotrizinol Impurity Mixture Benazepril HCl Benazepril Related Compound A (3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1benazapine-1-acetic acid, monohydrochloride Benazepril Related Compound B (Mixture of (1R,3S) and (1S, 3R) 3-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride) Benazepril Related Compound C (3S)-3-[[(1S)-1-(carboxy)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benazepine]1-acetic acid Benazepril Related Compound D 3-(1-Ethoxycarbonyl-3-cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)benzazepine-1-acetic acid monohydrochloride Benazepril Related Compound E 3-amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid, monohydrochloride Benazepril Related Compound F 3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid, tert-butyl ester Benazepril Related Compound G 3-(1-Ethoxycarbonyl-3-phenyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)benzazepine-1-acetic acid, ethyl ester Bendroflumethiazide Benoxinate HCl Benzaldehyde Benzalkonium Chloride Benzethonium Chloride Benzocaine Benzoic Acid Benzonatate 1,4-Benzoquinone

75 mg 15 mg 25 mg 15 mg 100 mg 200 mg 50 mg 15 mg 200 mg 1g 200 mg 350 mg 50 mg 500 mg 15 mg 200 mg 100 mg 25 mg 200 mg 500 mg 200 mg 100 mg 125 mg 25 mg

USP1048630

15 mg

USP1048641

50 mg

USP1048652

15 mg

USP1048663 USP1048674 USP1048685

25 mg 15 mg 15 mg

USP1049000 USP1050009 USP1050905 USP1051001 USP1051500 USP1054000 USP1055002 USP1056005 USP1056504

200 mg 200 mg 2x1 mL 5 mL 500 mg 500 mg 300 mg 1g 200 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

357

United States Pharmacopeia and National Formulary


Code Product Unit

USP1057507 USP1059003 USP1061005 USP1061901 USP1062008 USP1064003 USP1065006 USP1065210 New USP1065480 New USP1065491 USP1048288

Benzothiadiazine Related Compound A 4-Amino-6-chloro-1,3-benzenedisulfonamide Benzphetamine HCl Controlled Substance CIII Benztropine Mesylate Benzyl Alcohol Benzyl Benzoate 1-Benzyl-3-methyl-5-aminopyrazole HCl Bephenium Hydroxynaphthoate Berberine Chloride Beta Carotene Beta Carotene System Suitability Beta Glucan Beta Glucan from Baker's Yeast Saccharomyces cerevisiae Betadex Sulfobutyl Ether Sodium Betahistine HCl Betaine Betaine HCl Betamethasone Betamethasone Acetate Betamethasone Benzoate Betamethasone Dipropionate Betamethasone Sodium Phosphate Betamethasone Valerate Betamethasone Valerate Related Compound A Betamethasone 21-valerate (AS) Betaxolol HCl Betazole HCl Bethanechol Chloride Bicalutamide Bicalutamide Related Compound A N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfinyl]-2-hydroxy-2methyl-propanamide Bicalutamide Related Compound B (RS)-N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(3-fluorophenylsulfonyl)2-hydroxy-2-methylpropanamide Powdered Bilberry Extract Bile Salts Biochanin A Positive Bioreaction Biotin Biperiden Biperiden HCl Bisacodyl Bisacodyl Related Compound A 4,4'-(Pyridin-2-ylmethylene)diphenol Bisacodyl Related Compound B 2,4'-(Pyridin-2-ylmethylene)diphenol Bisacodyl Related Compound C 4-[(4-Hydroxyphenyl)(pyridin)-2-yl)methyl]phenyl acetate Bisacodyl Related Compound E 2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate 2,5-Bis-(D-arabino-1,2,3,4-tetrahydroxybutyl)pyrazine Bis(2-ethylhexyl)maleate Bisdesmethoxycurcumin
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 200 mg 200 mg 500 mg 5g 25 mg 500 mg 50 mg 3x250 mg 200 mg 1g

USP1065550 USP1065618 USP1065695 USP1065709 USP1066009 USP1067001 USP1067307 USP1067704 USP1068004 USP1069007 USP1069018 USP1069903 USP1070006 USP1071009 USP1071202 USP1071213

500 mg 200 mg 1g 200 mg 200 mg 500 mg 200 mg 125 mg 500 mg 200 mg 50 mg 200 mg 200 mg 200 mg 200 mg 25 mg

USP1071224

10 mg

USP1071268 USP1071304 New USP1071381 USP1071439 USP1071508 USP1072001 USP1073004 USP1074007 USP1074030 USP1074042 USP1074051 USP1074073 USP1074700 USP1075203 USP1075305
358

500 mg 10 g 20 mg 3 strips 200 mg 200 mg 200 mg 125 mg 20 mg 20 mg 20 mg 20 mg 25 mg 2g 30 mg


Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1075509 USP1075531 USP1075600 USP1075622 USP1075644 USP1075553 USP1075677 USP1075688 USP1075699 USP1075757 USP1076206 USP1076308 USP1076341 New USP1076115 USP1076250 USP1076261 USP1076352 USP1076363 USP1076374

p-Bis(di-n-propyl)carbamylbenzenesulfonamide Bismuth Citrate Bismuth Subcarbonate (AS) Bismuth Subgallate (AS) Bismuth Subnitrate (AS) Bismuth Subsalicylate Bisoctrizole Bisoctrizole Related Compound A 2-(2H-Benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl) phenol Bisoctrizole Resolution Mixture Bisoprolol Fumarate Powdered Black Cohosh Extract Bleomycin Sulfate Boric Acid (AS) Bosentan Boswellia Serrata Extract 3-Acetyl-11-Keto-Beta-Boswellic Acid Bretylium Tosylate Brinzolamide Brinzolamide Related Compound A (S)-(-)-4-ethylamino-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno-[3,2,e]-thiazine-6sulfonamide-1,1-dioxide Brinzolamide Related Compound B (R)-4-amino-2,3-dihydro-2-(3-methoxypropyl)-4H-thieno-[3,2,e]-thiazine-6-sulfonamide1,1-dioxide ethanedioate Bromazepam (AS) Controlled Substance CIV Bromocriptine Mesylate Bromodiphenhydramine HCl 8-Bromotheophylline Bromperidol Decanoate Brompheniramine Maleate Budesonide Bumetanide Bumetanide Related Compound A 3-Amino-4-phenoxy-5-sulfamoylbenzoic Acid Bumetanide Related Compound B 3-Nitro-4-phenoxy-5-sulfamoylbenzoic Acid Bupivacaine HCl Bupivacaine Related Compound A 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide (AS) Bupivacaine Related Compound B (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide (AS) Buprenorphine HCl Controlled Substance CIII Buprenorphine Related Compound A 21-[3-(1-propenyl)]7-alpha-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14tetrahydrooripavine Controlled Substance CII Bupropion HCl Bupropion HCl Related Compound A 2-(tert-butylamino)-4'-chloropropiophenone hydrochloride Bupropion HCl Related Compound B 2-(tert-butylamino)-3'-bromopropiophenone hydrochloride Bupropion HCl Related Compound C 1-(3-chlorophenyl)-2-hydroxy-1-propanone Bupropion HCl Related Compound F 1-(3-chlorophenyl)-1-hydroxy-2-propanone Buspirone HCl
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

50 mg 100 mg 1g 2g 1.5 g 100 mg 200 mg 25 mg 50 mg 200 mg 1.5 g 15 mg 1g 200 mg 1g 20 mg 200 mg 200 mg 50 mg

USP1076385

50 mg

USP1076465 USP1076501 USP1077005 USP1077708 USP1077887 USP1078008 USP1078201 USP1078303 USP1078325 USP1078336 USP1078507 USP1078518 USP1078529 USP1078700 USP1078711

100 mg 150 mg 200 mg 400 mg 15 mg 125 mg 200 mg 250 mg 10 mg 25 mg 500 mg 50 mg 50 mg 50 mg 25 mg

USP1078733 USP1078744 USP1078755 USP1078766 USP1078799 USP1078802


Edition 2012/2013

200 mg 15 mg 15 mg 40 mg 30 mg 200 mg
359

United States Pharmacopeia and National Formulary


Code Product Unit

USP1079000 USP1080000 USP1081002 USP1081501 USP1081807 USP1081829 USP1082300 USP1082504 USP1082606 USP1082708 USP1082901 USP1083008 USP1083100 USP1083303 USP1084000 USP1084306 USP1085003 USP1086006 New USP1086039 USP1086108 USP1086200 USP1086210 New USP1086221 USP1086301 USP1086312 USP1086334 USP1086356 USP1086378 USP1086403 USP1086436 USP1086447 USP1086800 USP1086855 USP1086866 USP1086888 USP1086902 USP1086935 USP1087009 USP1087031 USP1087202 USP1087359 USP1087406 USP1087508 USP1087701 USP1087803 USP1088001 USP1090706 USP1090717

Butabarbital Controlled Substance CIII Butacaine Sulfate Butalbital Controlled Substance CIII Butamben 1-Butanol 2-Butanol Butoconazole Nitrate Butorphanol Tartrate Controlled Substance CIV Butyl Acetate Butylated Hydroxytoluene Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate 2-tert-Butyl-4-hydroxyanisole 3-tert-Butyl-4-hydroxyanisole tert-Butylmethyl ether Butylparaben Cabergoline Caffeine Caffeine Melting Point Standard (Approximately 236C) Caftaric Acid Calcifediol Calcitonin Salmon Calcitonin Salmon Related Compound A N-acetyl-Cys(1)-calcitonin salmon Calcitonin Salmon Related Compound B calcitonin salmon-glycine Calcitriol Calcitriol Solution Calcium Acetate (AS) Calcium Ascorbate Calcium Benzoate Calcium Carbonate (AS) Calcium Chloride (AS) Calcium Cyclamate Calcium Gluceptate Calcium Hydroxide (AS) Calcium(-)-Hydroxycitrate Calcium Lactate Calcium Lactobionate Calcium Levulinate (AS) Calcium Pantothenate (Vitamin B5) Tribasic Calcium Phosphate (AS) Calcium Saccharate Calcium Stearate (AS) Calcium Sulfate (AS) Camphor Candelilla Wax Candesartan Cilexetil Candicidin Capecitabine Capecitabine Related Compound A 5'-deoxy-5-fluorocytidine

200 mg 600 mg 200 mg 200 mg 3x1.2 mL 3x1.2 mL 200 mg 350 mg 3x1.2 mL 500 mg 25 mg 200 mg 200 mg 3x1.2 mL 200 mg 125 mg 200 mg 1g 20 mg 75 mg 20 mg 20 mg 0.34 mg 10 mg 5 mL 1g 200 mg 200 mg 1g 1g 200 mg 200 mg 1g 150 mg 1g 200 mg 1g 200 mg 1g 200 mg 2g 1g 1g 250 mg 100 mg 200 mg 200 mg 10 mg

360

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1090728 USP1090739 USP1091006 USP1091040 USP1091505 USP1091108 USP1091200 USP1091221 USP1092009 USP1093001 USP1093012 USP1093023 USP1093205 USP1093500 USP1094004 USP1095506 USP1095517 USP1096000 USP1096407 USP1096509 USP1096531 USP1096553 USP1096600 New USP1096597 USP1096611 USP1096724 USP1096735 USP1096699 USP1096702 USP1096757 USP1096622 USP1096633

Capecitabine Related Compound B 5'-deoxy-5-fluorouridine Capecitabine Related Compound C 2',3'-O-carbonyl-5'-deoxy-5-fluoro-N4-(pentyloxycarbonyl) cytidine Capreomycin Sulfate Caprylic Acid Caprylocaproyl Polyoxylglycerides Capsaicin Captopril Captopril Disulfide Carbachol Carbamazepine (CRM) Carbamazepine Related Compound A 10,11-dihydrocarbamazepine Carbamazepine Related Compound B Iminostilbene Carbarsone Carbenicillin Indanyl Sodium Carbenicillin Monosodium Monohydrate Carbidopa Carbidopa Related Compound A 3-O-Methylcarbidopa Carbinoxamine Maleate Carboplatin Carboprost Tromethamine Carboxymethylcellulose Calcium (AS) Carboxymethylcellulose Sodium Carisoprodol Controlled Substance CIV Carisoprodol Related Compound A 2-hydroxymethyl-2-methylpentyl carbamate Carmellose Carmustine Carmustine Related Compound A 1,3-bis(2-chloroethyl)urea Carprofen Carprofen Related Compound A Carbazole Carteolol HCl Carvedilol Carvedilol Related Compound A 1-(4-(2-hydroxy-3-(2-(2-methoxyphenoxy)ethylamino)propoxy)-9H-carbazol-9-yl)-3(2-(2-methoxyphenoxy)ethylamino)propan-2-ol Carvedilol Related Compound B 3,3'-(2-(2-methoxyphenoxy)ethylazanediyl)bis(1-(9H-carbazol-4-yloxy)propan-2-ol) Carvedilol Related Compound C 1-(9H-Carbazol-4-yloxy)-3-(benzyl(2-(2-methoxyphenoxy)ethyl)amino)propan-2-ol Carvedilol Related Compound D 4-(Oxiran-2-ylmethoxy)-9H-carbazole Carvedilol Related Compound E 2-(2-methoxyphenoxy)ethylamine Carvedilol System Suitability Mixture carvedilol spiked with carvedilol related compound F Casticin (+)-Catechin Cathinone HCl alpha-Aminopropiophenone HCl Controlled Substance CI

20 mg 10 mg 250 mg 300 mg 200 mg 100 mg 200 mg 100 mg 200 mg 100 mg 50 mg 50 mg 200 mg 300 mg 200 mg 400 mg 25 mg 200 mg 100 mg 25 mg 1.5 g 1.5 g 1g 10 mg 500 mg 75 mg 10 mg 200 mg 50 mg 200 mg 200 mg 15 mg

USP1096644 USP1096655 USP1096666 USP1096677 USP1096688 USP1096779 USP1096790 USP1096804

15 mg 20 mg 15 mg 15 mg 25 mg 25 mg 25 mg 50 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

361

United States Pharmacopeia and National Formulary


Code Product Unit

USP1096848 USP1096906 USP1096917 USP1097104 USP1097308 USP1097400 USP1097603 USP1097614 USP1097625

Powdered Cat's Claw Extract Cefaclor Cefaclor, Delta-3-Isomer Cefadroxil Cefamandole Lithium Cefamandole Nafate Cefazolin Cefdinir Cefdinir Related Compound A 2(R)-2-[(Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamido]-2-[(2RS,5RS)5-methyl-7-oxo-2,4,5,7-tetrahydro-1H-furo[3,4-d][1,3]thiazin-2-yl]acetic acid Cefdinir Related Compound B (6R,7R)-7-[2-(2-amino-4-thiazolyl)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid Cefditoren Pivoxil Cefepime HCl Cefepime HCl System Suitability Cefepime Related Compound D (Z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetic acid Cefepime Related Compound E 1-{[(6R,7R)-7-Amino-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en -3-yl]methyl}-1methylpyrrolidin-1-ium chloride Cefixime Cefmenoxime HCl Cefmetazole Cefonicid Sodium Cefoperazone Dihydrate Ceforanide Cefotaxime Sodium Cefotetan Cefotiam HCl Cefoxitin Cefpiramide Cefpodoxime Proxetil Cefprozil (E)-Isomer Cefprozil L-Epimer (6R,7R)-7-[(S)-2-amino-2-(4-hydroxyphenyl)acetamido]-8-oxo-3-[(Z)-prop-1-enyl]-5-thia-1azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid Cefprozil (Z)-Isomer Cefprozil Cefprozil Related Compound D (6R,7R)-7-amino-8-oxo-3-[)-prop-1-enyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid Cefprozil Related Compound H (6R,7R)-7{(R)-2-[(R)-2-amino-2-(4-hydroxyphenyl)acetamido]-2-(4hydroxyphenyl)acetamido}-8-oxo-3-[(Z)-prop-1-enyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2carboxylic acid Cefprozil Related Compound K 3-(5-ethyl-7-oxo-2,4,5,7-tetrahydro1H-furo[3,4-d][1,3]thiazin-2-yl(-6-(4hydroxyphenyl)piperazine-2,5-dione Ceftazidime, Delta-3-Isomer Ceftazidime Pentahydrate Ceftiofur Sodium Ceftizoxime Ceftriaxone Sodium Ceftriaxone Sodium E-Isomer
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

1g 400 mg 30 mg 200 mg 200 mg 250 mg 400 mg 200 mg 10 mg

USP1097589

10 mg

USP1097590 USP1097636 USP1097647 New USP1097680 New USP1097691

350 mg 500 mg 25 mg 20 mg 25 mg

USP1097658 USP1097771 USP1097782 USP1097750 USP1097705 USP1097807 USP1097909 USP1097975 USP1098005 USP1098107 USP1098118 USP1098027 USP1098049 New USP1097997

500 mg 350 mg 200 mg 1g 200 mg 200 mg 350 mg 500 mg 350 mg 500 mg 300 mg 350 mg 50 mg 30 mg

USP1098050 New USP1098062 New USP1097986

200 mg 200 mg 30 mg

New USP1098016

30 mg

New USP1098038

30 mg

USP1098129 USP1098130 USP1098082 USP1098173 USP1098184 USP1098195


362

10 mg 300 mg 100 mg 350 mg 350 mg 25 mg


Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1098209 USP1098220 USP1098231 New USP1098504 New USP1098515 New USP1098526 USP1098322 USP1098355 USP1098300 USP1098388 USP1098399 USP1098402 USP1297770 USP1098708 USP1099008 USP1102000 USP1102408 USP1102500 USP1102805 USP1102929 USP1102930 USP1102974 USP1103003 USP1103105 USP1104006 USP1105009 New USP1105315 USP1105508 USP1107004 USP1107300 USP1107401 USP1107503 USP1109000 USP1110009 USP1110020 USP1111001 USP1111103 USP1111307 USP1111908 USP1112503 USP1115545 USP1115556 USP1115705 USP1117008 USP1118000 USP1118317 USP1118328

Cefuroxime Sodium Cefuroxime Axetil Cefuroxime Axetil Delta-3-Isomers Celecoxib Celecoxib Relaed Compound A 4-[5-(3-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Celecoxib Relaed Compound B 4-[3-(4-methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide Cellaburate (Cellulose Acetate Butyrate) Cellacefate (Cellulose Acetate Phthalate) Cellulose Acetate Microcystalline Cellulose (AS) Silicified Microcystalline Cellulose Powdered Cellulose (AS) Powdered Centella Asiatica Extract Cephaeline HBr Cephalexin Cephalothin Sodium Cephapirin Benzathine Cephapirin Sodium Cephradine Cetirizine Hydrochloride Cetirizine Related Compound A (RS)-2-[2-[4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester Cetrimonium Bromide Cetyl Alcohol Cetyl Palmitate Cetylpyridinium Chloride Powdered Chaste Tree Extract Chicoric Acid Chitosan Chloramphenicol Chloramphenicol Palmitate Chloramphenicol Palmitate Nonpolymorph A Chloramphenicol Palmitate Polymorph A Chlordiazepoxide Controlled Substance CIV Chlordiazepoxide HCl Controlled Substance CIV Chlordiazepoxide Related Compound A 7-Chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one 4-Oxide Chlorhexidine Chlorhexidine Acetate Chlorhexidine Related Compounds p-Chloroaniline Chlorobutanol Chlorogenic Acid -Chlorogenin Chloromethyl Isopropyl Carbonate Chloroprocaine HCl Chloroquine Phosphate Chloroquine Sulfate Chloroquine Related Compound A 4,7-dichloroquinoline

200 mg 350 mg 10 mg 200 mg 10 mg 10 mg 350 mg 125 mg 125 mg 1g 1g 1g 1g 200 mg 400 mg 200 mg 100 mg 500 mg 200 mg 250 mg 20 mg 1g 100 mg 50 mg 500 mg 1.5 g 100 mg 500 mg 200 mg 200 mg 200 mg 100 mg 200 mg 200 mg 25 mg 200 mg 200 mg 50 mg 200 mg 200 mg 50 mg 20 mg 100 mg 200 mg 500 mg 500 mg 25 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

363

United States Pharmacopeia and National Formulary


Code Product Unit

USP1121005 USP1122700 USP1122722 USP1123000 USP1123102 USP1124003 USP1125006 USP1126009 USP1129007 USP1130006 USP1119309 USP1130505 USP1130527 USP1131009 USP1131803 USP1132001 USP1133004 USP1133503 USP1133536 USP1133547 USP1133570 USP1133580 USP1133638 USP1134007 USP1134018 USP1134030 USP1134029 USP1134040 USP1134084 USP1134051 USP1134153 USP1134164 USP1134175 USP1134186

Chlorothiazide Chloroxylenol Chloroxylenol Related Compound A 2-chloro-3,5-dimethylphenol Chlorpheniramine Maleate Chlorpheniramine Maleate Extended-Release Tablets Drug Release Calibrator, Single Unit Chlorphenoxamine HCl Chlorpromazine HCl Chlorpropamide Chlortetracycline HCl Chlorthalidone Chlorthalidone Related Compound A 4'-Chloro-3'-sulfamoyl-2-benzophenone Carboxylic Acid Chlorzoxazone Chlorzoxazone Related Compound A 2-Amino-4-chlorophenol Cholecalciferol (Vitamin D3) Delta-4,6-cholestadienol Cholesteryl Caprylate Cholestyramine Resin Cholic Acid (AS) Choline Bitartrate Choline Chloride Chondroitin Sulfate Sodium Oversulfated Chondroitin Sulfate Chromium Picolinate Chymotrypsin Ciclopirox Ciclopirox Olamine Ciclopirox Related Compound A 3-Cyclohexyl-4,5-dihydro-5-methyl-5-isoxayzolyl acetic acid Ciclopirox Related Compound B 6-Cyclohexyl-4-methyl-2-pyrone Ciclopirox Related Compound C 6-Cyclohexyl-4-metylpyridin-2(1H)-one Cilistatin Ammonium Salt Cilostazol Cilostazol Related Compound A 6-hydroxy-3,4-dihydro-1H-quinolin-2-one Cilostazol Related Compound B 6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)-butoxy]-1H-quinolin-2-one Cilostazol Related Compound C 1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4dihydroquinolin-2(1H)-one Cimetidine Cimetidine HCl Allyl Cinnamate Cinnamic Acid Cinoxacin Ciprofloxacin Ciprofloxacin Ethylenediamine Analog 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)-amino]-3-quinoline-carboxylic acid hydrochloride Ciprofloxacin Formamide

200 mg 125 mg 25 mg 125 mg 60 tablets 200 mg 200 mg 200 mg 200 mg 200 mg 10 mg 350 mg 50 mg 5x30 mg 30 mg 200 mg 500 mg 2g 200 mg 200 mg 300 mg 10 mg 100 mg 300 mg 50 mg 125 mg 25 mg 25 mg 10 mg 100 mg 200 mg 50 mg 50 mg 50 mg

USP1134062 USP1134073 New USP1133999 New USP1133933 USP1134109 USP1134313 USP1134324

200 mg 200 mg 5x0.5 mL 100 mg 200 mg 200 mg 25 mg

USP1134459

125 mg

364

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1134335 USP1134346

Ciprofloxacin HCl Ciprofloxacin Related Compound A 7-Chloro-1-cyclopropyl-4-oxo-6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride salt (AS) Cisapride Cisplatin Citalopram HBr R-Citalopram Oxalate R-(-)-1-[3-(dimethylamino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate Citalopram Related Compound A 1-(3-(dimethyl)propyl)-1-(4'-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxamide Citalopram Related Compound B 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-5carbonitrile oxylate Citalopram Related Compound C 3-[3-(dimethylamino)-1-propyl](4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate Citalopram Related Compound D 1-(4'-fluorophenyl)-1-(3-(methylamino)propyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrochloride Citalopram Related Compound E 1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile-Noxide hydrochloride Citalopram Related Compound F dimethyl-(1-methyl-3,3-diphenyl-allyl)-amine hydrochloride Citalopram Related Compound G 1-(4'-fluorophenyl)-1-(3-dimethylaminopropyl)-5-chlorophthalane hydrobromide Citalopram Related Compound H 1-(4'-fluorophenyl)-1-(3-dimethylaminopropyl)-5-bromophthalane hydrobromide Citric Acid Cladribine Cladribine Related Compound A 2-methoxy-2'-deoxyadenosine Clarithromycin Clarithromycin Identity Clarithromycin Related Compound A 6,11-di-O-methylerythromycin A Clarithromycin Impurity D N-desmethyl clarithromycin Clarithromycin Impurity H N-formyl clarithromycin Clarithromycin Impurity Q N-oxide clarithromycin Clarithromycin Impurity R N-desmethyl erythromycin A Clavam-2-carboxylate Potassium Clavulanate Lithium Clemastine Fumarate Clenbuterol HCl Clenbuterol Related Compound B 1-(4-amino-3,5-dichlorophenyl)-2-tert-butylaminoethanone HCl Clidinium Bromide Clidinium Bromide Related Compound A 3-Hydroxy-1-methylquinuclidinium Bromide Climbazole Clindamycin HCl Clindamycin Palmitate HCl Clindamycin Phosphate Clioquinol

400 mg 25 mg

USP1134120 USP1134357 USP1134233 USP1134142 USP1134244 USP1134255

200 mg 100 mg 200 mg 10 mg 25 mg 25 mg

USP1134266 USP1134277

25 mg 15 mg

USP1134288

25 mg

USP1134299 USP1134197 USP1134222 USP1134368 USP1134200 USP1134211 USP1134379 USP1134390 USP1134380 USP1134619 USP1134620 USP1134631 USP1134642 USP1134404 USP1134426 USP1134506 USP1134674 USP1134696 USP1135000 USP1135021 USP1135600 USP1136002 USP1137005 USP1138008 USP1138201

200 mg 25 mg 25 mg 200 mg 200 mg 20 mg 100 mg 20 mg 50 mg 10 mg 10 mg 10 mg 10 mg 3.4 g 200 mg 250 mg 100 mg 10 mg 500 mg 250 mg 400 mg 200 mg 500 mg 250 mg 500 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

365

United States Pharmacopeia and National Formulary


Code Product Unit

USP1138405 USP1138427

Clobetasol Propionate Clobetasol Propionate Related Compound A 9-alpha-fluoro-11-beta-hydroxy-16-beta-methyl-3-oxo-androsta-1,4-diene-17(R)-spiro-2'[4'-chloro-5'-ethylfuran-3'(2'H)-one] Clocortolone Pivalate Clofazimine Clofibrate Clomiphene Citrate Clomiphene Related Compound A (E,Z)-2-[4-(1,2-diphenylethenyl)phenoxy]-N,N-diethylethanamine hydrochloride Clomipramine HCl Clonazepam Controlled Substance CIV Clonazepam Related Compound A 3-Amino-4-(2-chlorophenyl)-6-nitrocarbostyril Clonazepam Related Compound B 2-Amino-2'-chloro-5-nitrobenzophenone Clonazepam Related Compound C 2-Bromo-2'-(2-chlorobenzoyl)-4'-nitroacetanilide Clonidine Clonidine HCl Clonidine Related Compound A Acetylclonidine Clonidine Related Compound B 2-[(E)-2,6-Dichlorophenylimino]-1-(1-{2-[(E)-2,6-dichlorophenylimino]-imidazolidin-1-yl}ethyl)-imidazolidine Clopidogrel Bisulfate Clopidogrel Related Compound A (S)-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5-(4H)acetic acid, hydrochloride Clopidogrel Related Compound B (Methyl(+/-)-(o-chlorophenyl)-4,5-dihydrothienol[2,3-c]pyridine-6(7H)-acetate, hydrochloride Clopidogrel Related Compound C methyl(-)-(R)-(o-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate,hydrogen sulfate Cloprostenol Sodium Clorazepate Dipotassium Controlled Substance CIV Clorsulon Clotrimazole Clotrimazole Related Compound A (o-chlorophenyl)diphenylmethanol Cloxacillin Benzathine Cloxacillin Sodium Clozapine Clozapine Resolution Mixture Cocaine HCl Controlled Substance CII Cod Liver Oil Codeine N-Oxide Controlled Substance CI Codeine Phosphate Controlled Substance CII Codeine Sulfate Controlled Substance CII Colchicine Colestipol HCl Colistimethate Sodium Colistin Sulfate Copovidone Corn Oil (AS) Corticotropin
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

200 mg 50 mg

USP1138507 USP1138904 USP1139000 USP1140000 USP1140101 USP1140247 USP1140305 USP1140327 USP1140338 USP1140349 USP1140393 USP1140407 USP1140418 USP1140429

200 mg 200 mg 1g 500 mg 100 mg 200 mg 200 mg 25 mg 25 mg 25 mg 200 mg 200 mg 25 mg 25 mg

USP1140430 USP1140586

125 mg 20 mg

USP1140597 USP1140600

20 mg 20 mg

USP1140666 USP1140509 USP1140702 USP1141002 USP1141024 USP1141909 USP1142005 USP1142107 USP1142108 USP1143008 USP1145207 USP1143802 USP1144000 USP1145003 USP1146006 USP1146505 USP1147009 USP1148001 USP1148500 USP1148806 USP1149004
366

400 mg 125 mg 200 mg 200 mg 25 mg 200 mg 200 mg 100 mg 30 mg 250 mg 1g 50 mg 100 mg 250 mg 350 mg 200 mg 200 mg 200 mg 100 mg 1g 5 vials
Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1150003 USP1150207 USP1150353 USP1150502 USP1150513 USP1150706 USP1151006 USP1151709 USP1151855 USP1151866 USP1151924 USP1151935 USP1152009 New USP1152600 USP1152701 USP1154004 USP1154503 USP1154558 USP1154569 USP1154591 USP1154605 USP1154707 USP1154809 USP1154900 USP1156000 USP1157024 USP1157035 USP1157046 USP1157501 USP1158005 USP1158504 USP1158650 USP1159008 USP1161000 USP1161010 USP1161203 USP1161509 USP1161586 USP1162002 USP1162126 USP1162148 USP1162308 USP1162320 USP1162330 USP1162400 USP1162421

Cortisone Acetate Cottonseed Oil (AS) Creatinine Cromolyn Sodium Cromolyn Sodium Related Compound A 1,3-Bis-(2-acetyl-3-hydroxyphenoxy)-2-propanol (AS) Crospovidone Crotamiton Cumene Curcumin Curcuminoids Cyanidin Chloride Cyanidin-3-O-glucoside Chloride Cyanocobalamin (Vitamin B12) Cyclamic Acid Cyclandelate Cyclizine HCl Cyclobenzaprine HCl Alpha Cyclodextrin Beta Cyclodextrin Gamma Cyclodextrin Cyclohexylmethanol Cyclomethicone 4 Cyclomethicone 5 Cyclomethicone 6 Cyclopentolate HCl Cyclophosphamide Related Compound B 3-(2-chloroethyl)-2-oxo-2-hydroxy-1,3,6,2-oxadiazaphosphonane Cyclophosphamide Related Compound C (3-aminopropyl dihydrogen phosphate Cyclophosphamide Related Compound D 3-[2-(2-chloroethylamino)ethylamino]propyl dihydrogen phosphate dihydrochloride 2-Cyclopropylmethylamino-5-chlorobenzophenone Cycloserine Cyclosporine Cyclosporine Resolution Mixture Cyclothiazide (AS) Cyproheptadine HCl Cyproheptadine Related Compound A 5H-dibenzo[a,d]cycloheptene (AS) Cyromazine L-Cysteine HCl Cystine Cytarabine 5'-Cytidylic Acid Cytosine Dacarbazine Dacarbazine Related Compound A 5-aminoimidazole-4-carboxamide HCl Dacarbazine Related Compound B 2-azahypoxanthine Dactinomycin Daidzein

150 mg 1g 100 mg 500 mg 25 mg 100 mg 200 mg 3x1.2 mL 30 mg 300 mg 25 mg 15 mg 1.5 g 100 mg 200 mg 200 mg 200 mg 500 mg 250 mg 200 mg 2x1 mL 200 mg 200 mg 200 mg 300 mg 25 mg 25 mg 25 mg 50 mg 250 mg 50 mg 25 mg 200 mg 500 mg 40 mg 200 mg 200 mg 200 mg 250 mg 500 mg 100 mg 125 mg 50 mg 50 mg 50 mg 25 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

367

United States Pharmacopeia and National Formulary


Code Product Unit

USP1162432 USP1162501 USP1163140 USP1163151 USP1163162 USP1163173 USP1163184 USP1164008 USP1164700 USP1165408 USP1166003 USP1166309 USP1166400 USP1166502 USP1169001 USP1170000 USP1046089 USP1171003 USP1171207 USP1171251 USP1171455 USP1171706 USP1171900 USP1171910 USP1172006 USP1173009 USP1173100 USP1173202 USP1173235 USP1173246

Daidzin Danazol Dantrolene Dantrolene Sodium Dantrolene Related Compound A 5-(4-nitrophenyl)-2-furaldehyde azine Dantrolene Related Compound B 5-(4-nitrophenyl)-2-furaldehyde-(2-carboxymethyl)semicarbazone Dantrolene Related Compound C (5-(4-nitrophenyl)-2-furancarboxyaldehyde Dapsone Daunorubicin HCl Decoquinate Deferoxamine Mesylate Dehydroacetic Acid Dehydrocarteolol HCl Dehydrocholic Acid Demecarium Bromide Demeclocycline HCl N-Demethylazithromycin Denatonium Benzoate 23-EPI-26-Deoxyactein 2-Deoxy-D-Glucose (AS) Dermatan Sulfate Desacetyl Diltiazem HCl Desflurane Desflurane Related Compound A bis-(1,2,2,2-tetrafluoroethyl) ether Desipramine HCl Deslanoside Desmethoxycurcumin Desmopressin Acetate Desogestrel Desogestrel Related Compound A 13-ethyl-11-methylene-18,19-dinor-5alpha, 17alpha-pregn-3-en-20-yl-17-ol, desogestrel delta-3 isomer Desogestrel Related Compound B 3-Hydroxy-desogestrel Desogestrel Related Compound C 3-Keto-desogestrel Desosaminylazithromycin Desoximetasone Desoxycorticosterone Acetate Desoxycorticosterone Pivalate Dexamethasone Dexamethasone Acetate Dexamethasone Phosphate Dexbrompheniramine Maleate Dexchlorpheniramine Maleate Dexpanthenol Dextran 1 Dextran 40 Dextran 70

30 mg 200 mg 200 mg 100 mg 50 mg 50 mg 50 mg 125 mg 200 mg 200 mg 300 mg 200 mg 100 mg 200 mg 250 mg 200 mg 15 mg 200 mg 20 mg 100 mg 25 mg 50 mg 0.5 mL 0.1 mL 125 mg 100 mg 30 mg 1.93 mg 50 mg 15 mg

USP1173257 USP1173268 USP1046078 USP1173508 USP1174001 USP1175004 USP1176007 USP1176506 USP1177000 USP1178002 USP1179005 USP1179504 USP1179628 USP1179708 USP1179741

15 mg 25 mg 15 mg 200 mg 200 mg 125 mg 125 mg 200 mg 200 mg 200 mg 300 mg 500 mg 50 mg 50 mg 50 mg

368

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1179854 USP1179865 USP1179876 USP1179720 USP1179887 USP1179763 USP1179898 USP1179650 USP1179800 USP1180004 USP1180015 USP1180026 USP1180503 USP1181007 USP1181302 USP1181506 USP1182000 USP1183002 USP1184005 USP1184027 USP1185008 USP1185020 USP1023403 USP1186000 USP1187003 USP1187080 USP1187091 USP1187207 USP1187954 USP1188006 USP1188301 USP1188560 USP1188571 USP1188709 USP1188800 USP1188811 USP1189009 USP1190008 USP1190904 USP1191000 USP1191204 USP1191226 USP1191237 USP1191215 USP1192003
Edition 2012/2013

Dextran 4 Calibration Dextran 10 Calibration Dextran 40 Calibration Dextran 40 System Suitability Dextran 70 Calibration Dextran 70 System Suitability Dextran 250 Calibration Dextran T-10 Dextran Vo Marker Dextroamphetamine Sulfate Controlled Substance CII Dextroamphetamine Related Compound A 1-Phenyl-2-propanol Dextroamphetamine Related Compound B Phenyl acetone Controlled Substance CII Dextromethorphan Dextromethorphan HBr (CRM) Dextrose Diacetylated Monoglycerides Diacetylfluorescein Diacetylmorphine HCl (Heroin HCl) (AS) Controlled Substance CI Diatrizoic Acid Diatrizoic Acid Related Compound A 5-Acetamido-3-amino-2,4,6-triiodobenzoic Acid Diazepam Controlled Substance CIV Diazepam Related Compound A 2-Methyl-amino-5-chlorobenzophenone Diazepam Related Compound B 3-Amino-6-chloro-1-methyl-4-phenylcarbostyril Diazoxide Dibucaine HCl Dibutyl Phthalate Dibutyl Sebacate Dichloralphenazone Controlled Substance CIV 2,4-Dichlorophenol Dichlorphenamide Dichlorvos 2,2-dichlorovinyl dimethyl phosphate (AS) Diclazuril Diclazuril System Suitability Mixture Diclofenac Potassium Diclofenac Sodium Diclofenac Related Compound A N-(2,6-dichlorophenyl)indolin-2-one Dicloxacillin Sodium Dicumarol Dicyclohexyl Dicyclomine HCl Didanosine Didanosine Related Compound A Hypoxanthine Didanosine Related Compound B 2',3'-dideoxyadenosine Didanosine System Suitability Mixture Dienestrol
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 100 mg 100 mg 200 mg 100 mg 200 mg 100 mg 200 mg 100 mg 500 mg 25 mg 25 mg 2g 500 mg 500 mg 200 mg 200 mg 25 mg 100 mg 50 mg 100 mg 25 mg 25 mg 200 mg 500 mg 200 mg 1 mL 200 mg 100 mg 200 mg 150 mg 200 mg 50 mg 200 mg 200 mg 25 mg 500 mg 200 mg 2x2 mL 125 mg 200 mg 25 mg 25 mg 10 mg 125 mg
369

United States Pharmacopeia and National Formulary


Code Product Unit

USP1192808 USP1193006 USP1193265 USP1193301 USP1193505 USP1194009 USP1194803 USP1195001 USP1197007 USP1197302 USP1197506 USP1198000 USP1199002 USP1200000 USP1200600 USP1200804 USP1201002 USP1202005 USP1203008 USP1204000 USP1204102 USP1204805 USP1205003 USP1205014 USP1206006 USP1208001 USP1211006 USP1213001 USP1213103 New USP1213318 New USP1213329 USP1214004 USP1217909 USP1218005 USP1218016 USP1219008 USP1220302 USP1220506 USP1220700 USP1221000 USP1222002 USP1222400 USP1222501 USP1223005 USP1224008 USP1224201 USP1224507 USP1224551 USP1224562

Diethanolamine Diethylcarbamazine Citrate Diethylene Glycol Diethylene Glycol Monoethyl Ether Diethyl Phthalate Diethylpropion HCl Controlled Substance CIV Diethyl Sebacate Diethylstilbestrol Diethyltoluamide Diflorasone Diacetate Diflunisal Digitalis Digitoxin Digoxin Dihydrocapsaicin Dihydrocodeine Bitartrate Controlled Substance CII 17-Dihydroequilin Dihydroergotamine Mesylate Dihydrostreptomycin Sulfate Dihydrotachysterol Dihydroxyacetone Diloxanide Furoate Diltiazem HCl Diltiazem Related Compound A (AS) trans-diltiazem hydrochloride Dimenhydrinate Dimethisoquin HCl Dimethyl Sulfoxide Dinoprost Tromethamine Dinoprostone Diosmin Diosmin for System Suitability Dioxybenzone Diphenhydramine Citrate Diphenhydramine HCl Diphenhydramine Related Compound A 2-(Diphenylmethoxy)-N-methylethanamine HCl Diphenoxylate HCl Controlled Substance CII Dipivefrin HCl Dipyridamole Dirithromycin Disodium Guanylate Disodium Inosinate Disodium 5'-Uridylate Disopyramide Phosphate 2,4-Disulfamyl-5-trifluoromethylaniline Disulfiram Divalproex Sodium Dobutamine HCl Docetaxel Docetaxel Identification

3 mL 200 mg 0.5 mL 0.5 mL 200 mg 200 mg 1 mL 200 mg 3g 200 mg 200 mg 3g 200 mg 250 mg 25 mg 200 mg 50 mg 500 mg 200 mg 4x30 mg 250 mg 200 mg 200 mg 25 mg 200 mg 2g 3g 50 mg 50 mg 300 mg 15 mg 150 mg 200 mg 200 mg 15 mg 200 mg 200 mg 200 mg 200 mg 350 mg 500 mg 500 mg 200 mg 30 mg 200 mg 200 mg 600 mg 200 mg 50 mg

370

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

New USP1224573 USP1224620 USP1224664 USP1224700 USP1224904 USP1224802 USP1224824 USP1224937 USP1224948

Docetaxel System Suitability Mixture Docosahexaenoic Acid Ethyl Ester Docosyl Ferulate Docusate Calcium Docusate Potassium Docusate Sodium Docusate Sodium Related Compound B Disodium mono (2-ethylhexyl) sulfosuccinate Dofetilide Dofetilide Related Compound A N-[4-(2-(2-[4-(methanesulfonamido)phenoxy]ethyl)amino)phenyl] methanesulfonamide Dolasetron Mesylate Dolasetron Mesylate Related Compound A Hexahydro-8-hydroxy-2,6-methano-2H-quinolizin-3(4H)-one HCl Donepezil HCl Donepezil Related Compound A (E)-2-[(1-benzylpiperidin-4-yl)methylene]-5,6-dimethoxyindan-1-one Dopamine HCl Dorzolamide HCl Dorzolamide Hydrochloride Related Compound A (4R,6R)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno [2,3-b]thiopyran-2-sulfonamide 7,7-dioxide, monohydrochloride Dorzolamide Related Compound B (4R,6S)-4-(Ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2.3b]thiopyran-2sulfonamide 7,7-dioxide HCl Dorzolamide Related Compound D (4S,6S)-4-Amino-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2sulfonamide 7,7-dioxide HCl Doxapram HCl Doxazosin Mesylate Doxazosin Related Compound A N-(1,4-benzodioxane-2-carbonyl)piperazine hydrochloride Doxazosin Related Compound B 6,7-dimethoxyquinazoline-2,4-dione Doxazosin Related Compound C 2-chloro-4-amino-6,7-dimethoxyquinazoline Doxazosin Related Compound D 1,4-benzodioxane-2-carboxylic acid Doxazosin Related Compound E 2,4-dichloro-6,7-dimethoxyquinazoline Doxazosin Related Compound F N,N'-bis(1,4-benzodioxane-2-carbonyl)piperazine Doxepin HCl Doxepin Related Compound A dibenzo[b,e]oxepin-11(6H)-one Doxepin Related Compound B (11RS)-11-[3-(dimethylamino)propyl]-6,11-dihydrodibenzo[b,e]oxepin-11-ol Doxepin Related Compound C (E-3-(dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine HCl Doxorubicin HCl Doxycycline Hyclate Doxycycline Related Compound A 6-epidoxycycline Doxylamine Succinate Drometrizole 2-(2H-Benzotriazol-2-yl)-p-cresol

15 mg 500 mg 50 mg 500 mg 100 mg 500 mg 40 mg 200 mg 25 mg

USP1224959 USP1224960 USP1224981 USP1224992 USP1225204 USP1225281 USP1225292

200 mg 25 mg 200 mg 25 mg 200 mg 200 mg 20 mg

New USP1225317

15 mg

New USP1225306

15 mg

USP1225000 USP1225419 USP1225420 USP1225441 USP1225452 USP1225463 USP1225474 USP1225485 USP1225500 USP1225511 USP1225522 USP1225533 USP1225703 USP1226003 USP1226014 USP1227006 USP1228009

200 mg 200 mg 20 mg 20 mg 20 mg 20 mg 20 mg 15 mg 500 mg 50 mg 50 mg 25 mg 50 mg 200 mg 10 mg 300 mg 25 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

371

United States Pharmacopeia and National Formulary


Code Product Unit

USP1228010 USP1228029 USP1228031 USP1228042 USP1228053 USP1228064

Drometrizole Trisiloxane 2-(2H-Benzotriazol-2-yl)-6-{3-[bis(trimethylsiloxy)methylsilyl]isobutyl}-p-cresol Drometrizole Trisiloxane Related Compound A 2-(2H-Benzotriazol-2-yl)-6-(isobuten-1-yl)-p-cresol Drometrizole Trisiloxane Related Compound B 2-(2H-Benzotriazol-2-yl)-6-(isobuten-3-yl)-p-cresol Drometrizole Trisiloxane Related Compound C 2-(2H-Benzotriazol-2-yl)-6-(isobuten-1-yl)O1-[bis(trimethylsiloxy)methylsilyl]-p-cresol Drometrizole Trisiloxane Related Compound D 2-(2H-Benzothiazol-2-yl)-6-isobutyl-p-cresol Drometrizole Trisiloxane Related Compound E 2-(2H-Benzotriazol-2-yl)-6-{3-[bis(trimethylsiloxy)methylsilyl]isobutyl}-O1[bis(trimethylsiloxy)methylsilyl]-p-cresol Heptamethyl Trisiloxane 1,1,1,3,5,5,5-Heptamethyltrisiloxane Droperidol Drospirenone Drospirenone Related Compound A 17-Hydroxy-6beta,7beta:15beta,16beta-dimethylene-3-oxo-17beta-pregn-4ene-21-carboxylic acid, gamma-lactone Duloxetine HCl Duloxetine Related Compound A 5-Chloro-2-(3-chloromethyl-4H-1,2,4-triazol-4-yl)-benzophenone Duloxetine Related Compound F (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine HCl Duloxetine Related Compound H (S)-4-(Methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amino)-4-oxobutanoic acid Dyclonine HCl Dydrogesterone Dyphylline Ecamsule Solution Ecamsule Triethanolamine Ecamsule Related Compound A 1,4-Phenylenedimethanol Ecamsule Related Compound B 4-(hydroxymethyl)benzoic acid Ecamsule Related Compound C terephthalic acid Ecamsule Related Compound D ((1SR,4RS)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl)methanesulfonic acid Ecamsule Related Compound E sodium ((1SR,4SR,E)-3-(4-(hydroxymethyl)benzylidene)-7,7-dimethyl-2oxobicyclo[2.2.1]heptan-1-yl)methanesulfonate Ecamsule Related Compound F 4-((E)-((1SR,4SR)-7,7-dimethyl-3-oxo-4-(sulfomethyl)bicyclo[2.2.1]heptan-2ylidene)methyl)benzoic acid Ecamsule Related Compound G 4-((E)-((1SR,4SR)-7,7-dimethyl-3-oxo-4-(sulfomethyl)bicyclo[2.2.1]heptan-2ylidene)methyl)benzaldehydre, sodium salt Powdered Echinacea Angustifolia Extract Powdered Echinacea Pallida Extract Powdered Echinacea Purpurea Extract Econazole Nitrate Edetate Calcium Disodium Edetate Disodium Edetic Acid Edrophonium Chloride Efavirenz

200 mg 25 mg 25 mg 150 mg 25 mg 150 mg

USP1228075 USP1229001 USP1229409 USP1229410

150 mg 250 mg 200 mg 15 mg

USP1229817 USP1229828 USP1229872 USP1229883 USP1230000 USP1231003 USP1231502 USP1231580 USP1231604 USP1231615 USP1231626 USP1231637 USP1231648 USP1231659

100 mg 10 mg 10 mg 10 mg 200 mg 200 mg 200 mg 0.5 mL 200 mg 50 mg 50 mg 50 mg 50 mg 25 mg

USP1231660

25 mg

USP1231681

25 mg

USP1231706 USP1231717 USP1231728 USP1231808 USP1232006 USP1233009 USP1233508 USP1234001 USP1234103

1g 1g 1g 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg

372

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Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1234114

Efavirenz Racemic (+/-)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)2H-3,1-benzoxazin-2-one Efavirenz Related Compound A (S)-2-(2-amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-trifluorobut-3-yn-2-ol) Efavirenz Related Compound B (S,E)-6-Chloro-4-(2-Cyclopropylvinyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one Efavirenz Related Compound C 6-chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline Eicosapentaenoic Acid Ethyl Ester Eleutheroside B (Syringin) Eleutheroside E (Syringaresinol diglucoside) Powdered Eleuthero Extract Emedastine Difumarate Emetine HCl Emtricitabine Emtricitabine System Suitability Mixture A Emtricitabine System Suitability Mixture B Enalaprilat Enalapril Maleate Endotoxin Enflurane Enoxaparin Sodium Enoxaparin Sodium for Bioassays Enoxaparin Sodium Molecular Weight Calibrant A Enoxaparin Sodium Molecular Weight Calibrant B Enrofloxacin Enrofloxacin Related Compound Mixture Entacapone Entacapone Related Compound A (Z)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylacrylamide Ephedrine Sulfate Drug Precursor 4-Epianhydrotetracycline HCl (-)-Epigallocatechin-3-O-gallate Epilactose Epinephrine Bitartrate Epirubicin HCl Epitetracycline HCl (AS) Epoprostenol Sodium Epoprostenol Related Compound A 7-{(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(S,E)-3-hydrocyoct-1-enyl]cyclopentyl}-6oxoheptanoic acid Epoprostenol Related Compound B Sodium 5-(diphenylphosphinoyl)pentanoate Eprinomectin Eprosartan Mesylate (E)-2-Butyl-1-(pcarboxybenzyl)-alpha-2-thenylimidazole-5-acrylic acid, monomethanesulfonate Eprosartan Related Compound A (E)-3-(2-butyl-1H-imidazol-5-yl)-2-(thiophen-2-ylmethyl)acrylic acid HCl Eprosartan Related Compound B 3-(thiophen-2-yl)propanoic acid Eprosartan Related Compoud C 2-(thiophen-2-ylmethyl)malonic acid Eprosartan Related Compound D 4-(bromomethyl)benzoic acid
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

20 mg

USP1234125 USP1234147 USP1234136 USP1234307 USP1234668 USP1234680 USP1234704 USP1234806 USP1235004 USP1235106 USP1235128 USP1235139 USP1235274 USP1235300 USP1235503 USP1235809 USP1235820 New USP1235831 USP1235853 USP1235864 USP1235900 USP1235911 USP1235933 USP1235944 USP1236007 USP1236506 USP1236700 USP1236801 USP1237000 USP1237382 USP1237509 New USP1237600 New USP1237611

20 mg 15 mg 20 mg 500 mg 15 mg 15 mg 1.5 g 100 mg 300 mg 200 mg 15 mg 15 mg 300 mg 200 mg unit 1 mL 300 mg unit 6 mg 6 mg 200 mg 50 mg 150 mg 25 mg 200 mg 50 mg 20 mg 200 mg 200 mg 200 mg 200 mg 100 mg 15 mg

New USP1237622 New USP1237752 New USP1238217

15 mg 300 mg 50 mg

New USP1238228 New USP1238239 New USP1238240 New USP1238251

20 mg 15 mg 25 mg 15 mg

Edition 2012/2013

373

United States Pharmacopeia and National Formulary


Code Product Unit

New USP1238262 USP1238002 USP1239005 USP1239504 USP1240004 USP1241007 USP1241506 USP1241550 USP1241823 USP1241903 USP1242000 USP1242010 USP1242021 USP1242032 USP1243002 USP1245008 USP1246000 USP1247003 USP1248006 USP1249202 USP1249406 USP1249417 USP1249701 USP1249789 USP1249905 USP1249916 USP1250008 USP1250020 USP1250041 USP1251000 USP1252003 USP1254009 USP1254508 USP1255001 USP1255500 New USP1255850 USP1256004 USP1257007 USP1257018 USP1257029 USP1258305 USP1260001 USP1260012 USP1260023

Eprosartan Related Compound E 4-(hydroxymethyl)benzoic acid Equilin Ergocalciferol (Vitamin D2) Ergoloid Mesylates Ergonovine Maleate Drug Precursor Ergosterol Ergotamine Tartrate Drug Precursor Ergotaminine Drug Precursor Erythorbic Acid Erythritol Erythromycin Erythromycin B Erythromycin C Erythromycin Related Compound N N-Demethylerythromycin A Erythromycin Estolate Erythromycin Ethylsuccinate Erythromycin Gluceptate Erythromycin Lactobionate Erythromycin Stearate Escin Escitalopram Oxalate Escitalopram Related Compound A (-)4-[(4-dimethylamino)-1-(4-fluorophenyl)-1-(hydroxybutyl)]-3-(hydroxymethyl)benzonitrile Esmolol HCl Esomeprazole Magnesium Estazolam Controlled Substance CIV Estazolam Related Compound A 5-Chloro-2-(3-chloromethyl-4H-1,2,4-triazol-4-yl)-benzophenone Estradiol Estradiol Related Compound B 1,3,5(10),6-estratetraen-3,17beta-diol Estradiol Related Compound C 1,3,5(10)estratrien-3,17beta-diol-6-one Estradiol Benzoate (AS) Estradiol Cypionate Estradiol Valerate Estriol Estrone Estropipate Eszopiclone Controlled Substance CIV Ethacrynic Acid Ethambutol HCl Ethambutol Related Compound A (2R,2'S)-2,2'-[ethane-1,2-diylbis(azanediyl)]dibutan-1-ol Ethambutol Related Compound B ((2R,2'R)-2,2'-[ethane-1,2-diylbis(azanediyl]dibutan-1-ol)HCl Ethchlorvynol Controlled Substance CIV Ethinyl Estradiol Ethinyl Estradiol Related Compound A 6-Keto-ethinyl estradiol Ethinyl Estradiol Related Compound B 19-Nor-17alpha-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol

15 mg 25 mg 5x30 mg 300 mg 100 mg 50 mg 150 mg 100 mg 50 mg 200 mg 250 mg 100 mg 50 mg 50 mg 200 mg 200 mg 200 mg 200 mg 200 mg 350 mg 200 mg 10 mg 100 mg 10 mg 100 mg 10 mg 500 mg 10 mg 15 mg 250 mg 200 mg 100 mg 100 mg 200 mg 500 mg 100 mg 200 mg 200 mg 15 mg 15 mg 0.7 mL 150 mg 20 mg 10 mg

374

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1261004 USP1262801 USP1262823 USP1264002 USP1264501 USP1265005 USP1265402 USP1265424 USP1265457 USP1265504 USP1265515 USP1265592 USP1265606 USP1265526 USP1265537 USP1265548 USP1265559 USP1265560

Ethionamide Ethopabate Ethopabate Related Compound A Methyl-4-acetamido-2-hydroxybenzoate Ethosuximide Ethotoin Ethoxzolamide Ethyl Acetate Ethyl Acrylate and Methyl Metacrylate Copolymer Dispersion Ethylbenzene Ethylcellulose Ethylene Glycol Ethylene Glycol and Vinyl Alcohol Graft Copolymer Ethyl Formate 2-Ethylhexan-1-ol Ethylhexyl Triazone Ethylhexyl Triazone Related Compound A 2-ethylhexyl 4-aminobenzoate Ethylhexyl Triazone Related Compound B 4-(4,6-bis(4-((2-ethylhexyloxy)carbonyl)phenylamino)-1,3,5-triazin-2-ylamino)benzoic acid Ethylhexyl Triazone Related Compound C bis(2-ethylhexyl)4,4'-(6-(4-(ethyoxycarbonyl)phenylamino)-1,3,5-triazine-2,4diyl)bis(azanediyl)dibenzoate Ethyl Laurate Ethyl Lauroyl Arginate Ethyl Maltol Ethylnorepinephrine HCl Ethylparaben N-Ethylpiperazine Ethyl Vanillin Ethynodiol Diacetate Etidronate Disodium Etidronate Disodium Related Compound A Sodium phosphite dibasic pentahydrate Etidronic Acid Monohydrate Etodolac Etodolac Related Compound A (+/-)-8-ethyl-1-methyl-1,3,4,9-tetrahydropyrano[3,4-b]-indole-1-acetic acid Etomidate Etoposide Etoposide Resolution Mixture Eucalyptol Eugenol Exemestane Exemestane Related Compound A 6-Methyleneandrosta-4-ene-3,17-dione Exemestane Related Compound B 6-hydroxymethylandrostra-1,4-diene-3,17-dione Exemestane Related Compound C androsta-1,4-diene-3,17-dione Controlled Substance CIII Exemestane System Suitability Mixture Famciclovir Famciclovir System Suitability Mixture Mixture of Famciclovir, Propionylfamciclovir and 6-Chlorofamciclovir

200 mg 125 mg 25 mg 500 mg 200 mg 200 mg 3x1.2 mL 1.5 g 3x0.5 mL 1g 0.5 mL 1g 3x1.2 mL 1.5 mL 200 mg 20 mg 20 mg 20 mg

USP1265752 New USP1265800 USP1266008 USP1266507 USP1267000 USP1266802 USP1267500 USP1268003 USP1268502 USP1268513 USP1268604 USP1268706 USP1268728 USP1268750 USP1268808 USP1268852 New USP1268900 USP1268965 USP1269050 USP1269061 USP1269072 USP1269083 USP1269094 USP1269152 USP1269163

500 mg 200 mg 1g 200 mg 200 mg 0.5 mL 200 mg 200 mg 200 mg 300 mg 1g 400 mg 25 mg 200 mg 300 mg 30 mg 200 mg 500 mg 150 mg 15 mg 15 mg 15 mg 25 mg 200 mg 20 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

375

United States Pharmacopeia and National Formulary


Code Product Unit

USP1269174 USP1269185 New USP1269196 New USP1269130 New USP1269141 USP1269119 USP1269200 USP1269221

Famciclovir Related Compound A 2-[2-(2-Amino-9H-purin-9-yl)ethyl]propane-1,3-diol hydrochloride Famciclovir Related Compound B 4-(2-Amino-9H-purin-9-yl)-2-(hydroxymethyl)butyl acetate Famciclovir Related Compound C 4-(2-amino-9H-purin-9-yl)-2-methylbutyl acetate Famciclovir Related Compound E 2-aminopurine Famciclovir Related Compound F 2-Amino-6-chloropurine FAME Standard Mixture Famotidine Famotidine Related Compound B 3,5-bis[2-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphany]ethyl]-4H1,2,4,6-thiatriazine1,1-dioxide (AS) Famotidine Related Compound C 3-[[2-(diaminomethyleneamino)thiazol-4-yl]methylthio]-N-sulfamoylpropanamide HCl Famotidine Related Compound D 3-[[2-(diaminomethyleneamino)thiazol-4-yl]methylthio]propanamide Famotidine Related Compound E 2,2'-[4,4'-disulfanediylbis(methylene)bis(thiazole-4,2-diyl)]diguanidine Famotidine Related Compound F 3-[[2-(diaminomethyleneamino)thiazol-4-yl]methylthio]propanoic acid Famotidine Sulfoxide 3-[[2-(diaminomethyleneamino)thiazol-4-yl]methylsulfinyl]-N'-sulfamoylpropanimidamide Felbamate Felbamate Related Compound A 3-Hydroxy-2-phenylpropyl carbamate Felbamate Related Compound B Phenethyl carbamate Felodipine Felodipine Related Compound A ethyl methyl 4-(2,3-dichlorophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate Fenbendazole Fenbendazole Related Compound A Methyl(1H-benzimidazole-2-yl)carbamate Fenbendazole Related Compound B Methyl[5(6)-chlorobenzimidazole-2-yl]carbamate Fenofibrate Fenofibrate Related Compound A (4-chlorophenyl)(4-hydroxyphenyl) methanone Fenofibrate Related Compound B 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid Fenofibrate Related Compound C 1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl]oxy]-2methylpropanoate Fenoldopam Mesylate Fenoldopam Related Compound A N-Methyl-6-chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-1H-3-benzazepine-7,8-diol HCl Fenoldopam Related Compound B 1H-3-Benzazapine-7,8-diol, 2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-, methanesulfonate Fenoprofen Calcium Fenoprofen Sodium Fentanyl Controlled Substance CII Fentanyl Citrate Controlled Substance CII Fentanyl Related Compound A (2-bromoethyl)benzene Fentanyl Related Compound B 4-Anilinopiperidine

20 mg 20 mg 20 mg 25 mg 25 mg 100 mg 125 mg 25 mg

USP1269232 USP1269243 USP1269254 USP1269265 USP1269298 USP1269312 USP1269323 USP1269334 USP1269389 USP1269390 USP1269403 USP1269414 USP1269425 USP1269447 USP1269607 USP1269618 USP1269629

25 mg 25 mg 25 mg 25 mg 25 mg 250 mg 25 mg 25 mg 300 mg 15 mg 100 mg 30 mg 30 mg 200 mg 25 mg 25 mg 25 mg

USP1269458 USP1269469 USP1269470 USP1269505 USP1269550 USP1269902 USP1270005 USP1269913 USP1269924

200 mg 20 mg 20 mg 500 mg 500 mg 100 mg 100 mg 100 mg 10 mg

376

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Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1269946 USP1269957 USP1269979 USP1270355 USP1270311 USP1270377 USP1270388

Fentanyl Related Compound D N-Phenyl-1-(phenylmethyl)-4-piperidinamine Fentanyl Related Compound E N-Phenyl-1-(2-phenylethyl)-4-piperidinamine Controlled Substance CII Fentanyl Related Compound G Acetyl fentanyl Ferrous Sulfate Ferulic Acid trans-4-hydroxy-3-methoxycinnamic acid Fexofenadine HCl Fexofenadine Related Compound A 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-dimethyl benzeneacetic acid Fexofenadine Related Compound B 3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-dimethyl benzeneacetic acid hydrochloride Fexofenadine Related Compound C (+)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-isopropylbenzene (AS) Finasteride Fish Oil Flavoxate HCl Flavoxate Related Compound A 3-methylflavone-8-carboxylic acid Flavoxate Related Compound B 3-Methylflavone-8-carboxylic acid methyl ester Flavoxate Related Compound C 3-Methylflavone-8-carboxylic acid ethyl ester Flecainide Acetate Flecainide Related Compound A 3-[2,5-bis(2,2,2-trifluoroethoxy) phenyl]-1,5,6,7,8,8a-hexahydroimidazo-[1,5a]pyridine HCl Floxuridine Fluconazole Fluconazole Related Compound A 2-[2-fluoro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)-propan-2-ol Fluconazole Related Compound B 2-(4-fluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-propan-2-ol Fluconazole Related Compound C 1,1'-(1,3-phenylene)di(1H-1,2,4-triazole) Flucytosine Fludarabine Phosphate Fludeoxyglucose Fludeoxyglucose Related Compound A 4,7,13,16,21,24-hexaoxa-1,10-diazabicyclo[8.8.8.]hexacosane Fludeoxyglucose Related Compound B 2-chloro-2-deoxy-D-glucose Fludrocortisone Acetate Flumazenil Flumazenil Related Compound A 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazol-[1,5-alpha] [1,4]benzodiazepine-3-carboxylic acid Flumazenil Related Compound B Ethyl 8-hydroxy-5,6-dihydro-5-methyl-6-oxo-4H-imidazol-[1,5-alpha] [1,4]benzodiazepine-3-carboxylate Flumazenil Related Compound C N,N-Dimethylformamide diethyl acetal Flumethasone Pivalate Flunisolide Flunixin Meglumine

10 mg 10 mg 10 mg 1.5 g 25 mg 200 mg 25 mg

USP1270399

25 mg

USP1270446 USP1270402 USP1270424 USP1270708 USP1270719 USP1270720 USP1270731 USP1270800 USP1270821 USP1271008 USP1271700 USP1271711 USP1271722 USP1271733 USP1272000 USP1272204 USP1272907 USP1272918 USP1272929 USP1273003 USP1273808 USP1273819

15 mg 200 mg 1g 200 mg 25 mg 20 mg 20 mg 200 mg 75 mg 250 mg 200 mg 10 mg 10 mg 10 mg 200 mg 300 mg 100 mg 15 mg 10 mg 250 mg 200 mg 20 mg

USP1273820

20 mg

USP1273841 USP1274006 USP1274505 USP1274607

500 mg 200 mg 200 mg 300 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

377

United States Pharmacopeia and National Formulary


Code Product Unit

USP1275009 USP1276001 USP1277004 USP1277252 USP1277274 USP1277300 USP1277354 USP1277401 USP1277423 USP1277456 USP1278007 USP1278109 USP1278302 USP1279000 USP1279804 USP1279815 USP1279826 USP1279837 USP1280009 USP1280803 USP1281001 USP1282004 USP1284000 USP1285002 USP1285308 USP1285603 USP1285750 USP1285760 USP1285807 USP1285851 USP1285862 USP1285873 USP1285910 USP1285840 USP1285884 USP1285895 USP1285931 USP1285964

Fluocinolone Acetonide Fluocinonide Fluorescein Fluoride Dentifrice: Sodium Fluoride/Silica Fluoride Dentifrice: Sodium Fluoride/Sodium Bicarbonate Powder Fluoride Dentifrice: Sodium Monofluorophosphate - Calcium Carbonate Fluoride Dentifrice: Sodium Monofluorophosphate/Dicalcium Phosphate Fluoride Dentifrice: Sodium Monofluorophosphate (1000 ppm)/Silica Fluoride Dentifrice: Sodium Monofluorophosphate (1500 ppm)/Silica Fluoride Dentifrice: Stannous Fluoride-Silica Fluorometholone Fluorometholone Acetate Fluoroquinolonic Acid Fluorouracil Fluoxetine HCl Fluoxetine Related Compound A N-methyl-3-phenyl-3-[(alpha,alpha,alpha-(trifluoro-m-tolyl)oxy]propylamine HCl Fluoxetine Related Compound B N-methyl-3-phenylpropylamine Controlled Substance Fluoxetine Related Compound C N-Methyl-N-[3-phenyl-3-(4-trifluoromethyl-phenoxy)-propyl] succinamic acid Fluoxymesterone Controlled Substance CIII Fluphenazine Decanoate Dihydrochloride Fluphenazine Enanthate Dihydrochloride Fluphenazine HCl Flurandrenolide Flurazepam HCL Controlled Substance CIV Flurazepam Related Compound C 5-chloro-2-(2-diethylaminoethyl(amino)-2'-fluorobenzophenone HCl Flurazepam Related Compound F 7-chloro-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepine-2-one) Flurbiprofen Flurbiprofen Related Compound A 2-(4-Biphenylyl)propionic Acid Flurbiprofen Sodium Flutamide o-Flutamide Fluticasone Propionate Fluticasone Propionate Nasal Spray Resolution Mixture Fluticasone Propionate Related Compounds Mixture Fluticasone Propionate Resolution Mixture Fluticasone Propionate System Suitability Mixture Fluticasone Propionate and Fluticasone Propionate Related Compounds B, C and D Fluvastatin Sodium Fluvastatin Related Compound B [R*,S*-E](+/-)-7-[3-(4-fluorophenyl)-1-methylethyl-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid 1,1-dimethylethyl ester Fluvastatin for System Suitability Fluvastatin sodium and fluvastatin sodium anti-isomer ([R*,R*-E](+/-)-7-[3-(4-fluorophenyl)-1(methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid monosodium salt Fluvoxamine Maleate Folic Acid (Vitamin M or Vitamin Bc) Folic Acid Related Compound A Calcium Formyltetrahydrofolate Formic Acid
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

100 mg 100 mg 200 mg 4.6 oz 4 oz 4.6 oz 4.6 oz 5.25 oz 5.25 oz 4 oz 200 mg 200 mg 150 mg 250 mg 200 mg 15 mg 5 mL 15 mg 200 mg 500 mg 125 mg 125 mg 100 mg 200 mg 50 mg 50 mg 200 mg 100 mg 200 mg 200 mg 50 mg 100 mg 25 mg 25 mg 25 mg 25 mg 350 mg 15 mg

USP1285942

25 mg

USP1285909 USP1286005 USP1286027 USP1283200


378

200 mg 500 mg 50 mg 3x1.2 mL


Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1286060 USP1286107 USP1286129 USP1286118 USP1286300 USP1283244 USP1283255 USP1283302 USP1283313 USP1283324 USP1286322 USP1283404 USP1283415 USP1283426

Formononetin Formoterol Fumarate Formoterol Fumarate Resolution Mixture Formoterol Fumarate System Suitability Mixture 10-Formylfolic Acid Forskolin 7Beta-acetoxy-8,13-epoxy-1alpha,6Beta,9alpha-trihydroxy-labd-14-en-11-one Powdered Forskohlii Extract Foscarnet Sodium Foscarnet Related Compound B Disodium (Ethoxyoxidophosphanyl) formate Foscarnet Related Compound D O,O-diethyl ethoxycarbonylphosphonate Fosfomycin Tromethamine Fosinopril Sodium Fosinopril Related Compound A (4S)-4-cyclohexyl-[(4-phenylbutyl)phosphinyl]-acetyl-L-proline Fosinopril Related Compound B ((4S)-4-Cyclohexyl-1-[(R)-[(S)-1-hydroxy-2-methylpropoxy](4-phenylbutyl)phosphinyl]acetylD-proline propionate (ester), hemibarium salt, sesquihydrate) Fosinopril Related Compound C (4S)-4-cyclohexyl-1-[(RS)-1-hydroxy-2-methylpropoxy](4-phenylbutyl)phosphinyl]-acetyl-Lproline propionate (ester),sodium salt Fosinopril Related Compound D (4R)-4-cyclohexyl-1-[(R)-[(S]-1-hydroxy-2-methylpropoxy](4-phenylbutyl)phosphinyl]acetyl-Lproline propionate (ester), sodium salt Fosinopril Related Compound E (4S)-4-phenyl-1-[(R)-[(S)-1-hydroxy-2-methyl-propoxy](4-phenylbutyl]phospinyl]acetyl-Lproline propionate (ester), sodium salt Fosinopril Related Compound F (4S)-4-cyclohexyl-1-[(R)-[(S)-1-hydroxypropoxy](4-phenylbutyl)phospinyl]acetyl-L-proline propionate (ester),sodium salt Fosinopril Related Compound G (4-phenylbutyl)phosphinyl acetic acid, disodium salt Fosinopril Related Compound H 4-phenylbutyl phosphonic acid Fosphenytoin Sodium Fructose L-Fucose (AS) Fulvestrant Fulvestrant System Suitability Mixture Fumaric Acid Furazolidone Furosemide Furosemide Related Compound A 2-Chloro-4-N-furfurylamino-5-sulfamoylbenzoic Acid Furosemide Related Compound B 4-Chloro-5-sulfamoylanthranilic Acid Gabapentin Gabapentin Related Compound A 2-Azaspiro[4.5]decan-3-one Gabapentin Related Compound B (1-cyanocyclohexyl)acetic acid Gabapentin Related Compound D (1-(3-oxo-2-aza-spiro[4,5]dec-2-ylmethyl)-cyclohexyl)acetic acid Gabapentin Related Compound E carboxymethyl-cyclohexanecarboxylic Acid Gadodiamide

50 mg 100 mg 20 mg 20 mg 25 mg 40 mg 500 mg 50 mg 10 mg 0.27 mL 800 mg 200 mg 25 mg 15 mg

USP1283437

15 mg

USP1283448

15 mg

USP1283459

15 mg

USP1283460

15 mg

USP1283470 USP1283481 USP1286366 USP1286504 USP1286606 USP1286650 USP1286661 USP1286708 USP1286800 USP1287008 USP1287020 USP1287030 USP1287303 USP1287325 USP1287347 USP1287358 USP1287369 USP1287507

15 mg 25 mg 250 mg 125 mg 200 mg 150 mg 15 mg 200 mg 200 mg 200 mg 50 mg 100 mg 250 mg 50 mg 30 mg 10 mg 10 mg 500 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

379

United States Pharmacopeia and National Formulary


Code Product Unit

USP1287518 USP1287529 USP1287609 USP1287631 USP1287642 USP1287653 USP1287664 USP1287675 USP1287686

Gadodiamide Related Compound A gadolinium sodium diethylenetriamine pentaacetic acid monomethylamide Gadodiamide Related Compound B gadolinium disodium diethylenetriamine pentaacetic Acid Gadopentetate Monomeglumine Gadoteridol Gadoteridol Related Compound A 10-(2-hydroxypropyl)-1,4,7,10-tetraazacyclodedodecane-1,4,7-triaacetic Acid Gadoteridol Related Compound B 1,4,7,10-Tetraazacyclododecane-1,4,7-triacetic acid, monogadolinium salt Gadoteridol Related Compound C 1,4,7,10-Tetraaza-11-oxo-bicylco[8.2.2]tetradecan-4,7-diacetic Acid Gadoversetamide Gadoversetamide Related Compound A Hydrogen[8,11,14-tris(carboxymethyl)-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan16-oato(4-)]gadolinium Galactitol Galactosamine HCl Galactose Galantamine HBr Galantamine HBr Racemic Galantamine HBr Related Compounds Mixture Gallamine Triethiodide Ganciclovir Ganciclovir Related Compound A (RS)-2-Amino-9-(2,3-dihydroxy-propoxymethyl)-1,9-dihydropurin-6-one Ganciclovir Mono-N-methyl Valinate 2-(RS)-[(guanin-9-yl)methoxy]-3-hydroxypropyl N-methyl-L-valinate hydrochloride Gatifloxacin Powdered Garcinia Hydroxycitrate Extract Gemcitabine Hydrochloride Gemfibrozil Gemfibrozil Related Compound A 2,2-dimethyl-5-[2,5-dimethyl-4-propene-1-yl)phenoxy]valeric acid Genistein Genistin Gentamicin Sulfate Gentian Violet Gibberellic Acid Powdered Ginger Ginger Constituent Mixture 6-gingerol and 6-shogaol Ginkgo Terpene Lactones Ginkgolic Acids Powdered American Ginseng Extract Powdered Asian Ginseng Extract Gitoxin Glimepiride Glimepiride Related Compound A Glimepiride cis-isomer Glimepiride Related Compound B Glimepiride Sulfonamide Glimepiride Related Compound C Glimepiride urethane Glimepiride Related Compound D Glimepiride-3-isomer
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

50 mg 50 mg 500 mg 500 mg 50 mg 50 mg 50 mg 200 mg 200 mg

USP1287711 USP1287722 USP1287700 USP1287755 USP1287766 USP1287777 USP1288000 USP1288306 USP1288317 USP1288339 USP1288408 USP1288340 USP1288463 USP1288500 USP1288510 USP1288816 USP1288805 USP1289003 USP1290002 USP1291005 USP1291504 USP1291446 USP1291559 USP1291548 USP1291683 USP1291708 USP1292008 USP1292303 USP1292314 USP1292325 USP1292336 USP1292347

500 mg 300 mg 200 mg 200 mg 15 mg 25 mg 200 mg 200 mg 15 mg 10 mg 300 mg 500 mg 200 mg 200 mg 20 mg 15 mg 30 mg 200 mg 650 mg 200 mg 500 mg 0.2 mg 50 mg 10 mg 1.5 g 1.5 g 50 mg 200 mg 20 mg 20 mg 20 mg 20 mg

380

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1292507 USP1292609 USP1292610 USP1292631 New USP1294036 USP1294207 USP1294976 USP1294987 USP1294808 USP1294820 USP1294848 USP1295505 USP1295516 USP1295527 USP1295607 USP1295709 USP1295724 USP1295731 USP1295753 USP1295742 USP1295800 USP1295844 USP1295855 USP1294284 USP1296009 USP1296010 USP1296029 USP1296031 USP1296042 USP1295888 USP1296756 USP1296767 USP1297001 USP1297205 USP1297216 New USP1297250 USP1298004 USP1298106 USP1298117 USP1298128 USP1298139

Glipizide Glipizide Related Compound A N-{2-[(4-aminosulfonyl)phenyl]ethyl}-5-methyl-pyrazinecarboxamide Glipizide Related Compound B 6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide Glipizide Related Compound C 1-cyclohexyl-3-[[4-[2-[[(6-methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]sulfonyl]urea rGlucagon recombinant Glucagon (Human) Glucosamine HCl Glutamic Acid L-Glutamic Acid HCl Glutamine Glutathione gamma-Glutamyl-(S)-allyl-L-cysteine Glyburide Glyburide Related Compound A 5-chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benzamide Glyburide Related Compound B methyl-[[4-[2-[5(-chloro-2-methoxybenzoyl)-amino]ethyl]phenyl]sulfonyl]carbamate (AS) Glycerin Glyceryl Behenate Glyceryl Distearate Glyceryl Monolinoleate Glyceryl Monooleate 40% Glyceryl Monooleate 90% Glycine Glycitein Glycitin N-Glycolylneuraminic Acid Glycopyrrolate Glycopyrrolate Erythro Isomer (RS)-3-[(RS)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy]-1,1-dimethylpyrrolidinium bromide Glycopyrrolate Related Compound A 5-Nitrobenzene-1,3-dicarboxylic acid Glycopyrrolate Related Compound B 1-Metyhlpyrrolidin-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate Glycopyrrolate Related Compound C 2-Cyclopentyl-2-hydroxy-2-phenylacetic acid Glycyrrhizic Acid Gonadorelin Acetate Gonadorelin Acetate Related Compound A Gonadorelin free acid trifluoroacetate salt Human Chorionic Gonadotropin - 5,760 USP units per package Goserelin Acetate Goserelin Related Compound A 4-D-Serine Goserelin Goserelin System Suitability Mixture Gramicidin Granisetron HCl Granisetron Related Compound A 2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-2H-indazole-3-carboxamide Granisetron Related Compound B N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide Granisetron Related Compound C N-[(1R,3r,5S)-9-azabicyclo[3.3.1]non-3-yl]-1-methyl-1H-indazole-3-carboxamide HCl
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

125 mg 25 mg 15 mg 15 mg 2x2.94 mg 200 mg 200 mg 100 mg 100 mg 300 mg 25 mg 200 mg 25 mg 25 mg 2 mL 200 mg 500 mg 500 mg 500 mg 250 mg 200 mg 15 mg 15 mg 200 mg 200 mg 25 mg 50 mg 75 mg 25 mg 25 mg 50 mg 10 mg vial 100 mg 2 mg 1 mg 200 mg 150 mg 15 mg 15 mg 15 mg

Edition 2012/2013

381

United States Pharmacopeia and National Formulary


Code Product Unit

USP1298140 USP1298150 USP1298208 USP1298219 USP1298401 USP1299007 USP1299200 USP1300004 USP1301007 USP1301404 USP1301608 USP1301801 USP1302101 USP1302156 USP1302203 USP1302214 New USP1302247 New USP1302258 USP1302305 USP1302509 USP1302906 USP1303002 USP1303057 USP1303013 New USP1303024 USP1303501 USP1304005 USP1304016 USP1304038 USP1304049 USP1304050 USP1304209 USP1305008 USP1305303 USP1305507 USP1307003 USP1308006 USP1308200 USP1308307 USP1308505 USP1309009 USP1310008 USP1311000 USP1311306 USP1311408 USP1313006 USP1313210

Granisetron Related Compound D 1-methyl-1H-indazole-3-carboxylic acid Granisetron Related Compound E (1R,3r,5S)-9-azabicyclo[3.3.1]nonan-3-amine acetate Grape Seeds Oligomeric Proanthocyanidins Purified Grape Seeds Oligomeric Proanthocyanidins Powdered Decaffeinated Green Tea Extract Griseofulvin Griseofulvin Permeability Diameter Guaiacol Guaifenesin Guanabenz Acetate Guanadrel Sulfate Guanethidine Monosulfate Guanfacine HCl Guanine Purified Guggul Extract Guggulsterone Z Gymnemagenin Native Gymnema Extract Halazepam (AS) Controlled Substance CIV Halcinonide Halobetasol Propionate Haloperidol Haloperidol Decanoate Haloperidol Related Compound A 4,4'-Bis[4-(p-chlorophenyl)-4-hydroxy-piperidino]-butyrophenone Haloperidol Related Compound B 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(2-fluorophenyl)butan-1-one Halothane Heparin Sodium Heparin Sodium for Assays Heparin Sodium Identification Heparin Sodium System Suitability Heparin Sodium with Oversulfated Chondroitin Sulfate Heptane Hexachlorophene Hexacosanol 2E,4E-Hexadienoic Acid Isobutylamide Hexobarbital Controlled Substance CIII Hexylcaine HCl Hexylene Glycol Hexylresorcinol L-Histidine Histamine Dihydrochloride Homatropine HBr Homatropine Methylbromide Homopolymer Polypropylene Homosalate Hydralazine HCl Hydrastine

15 mg 15 mg 500 mg 500 mg 300 mg 200 mg 2g 1g 200 mg 200 mg 200 mg 200 mg 125 mg 100 mg 500 mg 25 mg 15 mg 1g 200 mg 200 mg 200 mg 200 mg 200 mg 10 mg 10 mg 1 mL 10x1 mL 9.5 mg 50 mg 50 mg 8.8 mg 3x1.2 mL 500 mg 100 mg 25 mg 500 mg 1g 125 mg 200 mg 200 mg 250 mg 200 mg 250 mg 3 strips 500 mg 200 mg 10 mg

382

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1314009 New USP1314960 USP1315001 USP1315012 USP1316004 USP1317007 USP1317302 USP1318000 USP1319002 USP1320001 USP1321004 USP1322007 USP1323000 USP1323019 USP1323021 USP1324002 USP1325005 USP1327000 USP1327408 USP1329006 USP1329709 USP1329800 USP1331008 USP1332000 USP1333003 USP1333058 USP1334006 USP1335009 USP1335010 USP1335202 USP1330005 USP1335279 USP1335304 New USP1335417 USP1335428 USP1335508 USP1335541 USP1335701 USP1336001 USP1336205 USP1336500 USP1336806 USP1337004 USP1337809 USP1338007 USP1338313

Hydrochlorothiazide Hydrocodone Controlled Substance CII Hydrocodone Bitartrate Controlled Substance CII Hydrocodone Bitartrate Related Compound A Morphinan-6-one, 4-hydroxy-3-methoxy-17-methyl Controlled Substance CII Hydrocortisone Hydrocortisone Acetate Hydrocortisone Butyrate Hydrocortisone Cypionate Hydrocortisone Hemisuccinate Hydrocortisone Phosphate Triethylamine Hydrocortisone Valerate Hydroflumethiazide Hydromorphone HCl Controlled Substance CII Hydromorphone N-Oxide HCl Controlled Substance CII UB Hydromorphone Related Compound A Controlled Substance CII UB 7,8-didehydro-4,5alpha-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride Hydroquinone Hydroxyamphetamine HBr Hydroxychloroquine Sulfate 6-Hydroxynicotinic Acid Hydroxyprogesterone Caproate Hydroxypropyl Betadex Hydroxypropyl Cellulose 12-Hydroxystearic Acid Hydroxyurea Hydroxyzine HCl Hydroxyzine Related Compound A p-Chlorobenzhydrylpiperazine Hydroxyzine Pamoate Hyoscyamine Sulfate Hyoscyamine Related Compound A Norhyoscyamine Sulfate Hyperoside Hypromellose (Hydroxypropyl Methylcellulose) Hypromellose Acetate Succinate Hypromellose Phthalate Ibandronate Sodium Ibandronate Related Compound A 3-[Methyl(pentyl)amino]propanoic acid HCl Ibuprofen Ibuprofen Related Compound C 4-isobutylacetophenone Idarubicin HCl Idoxuridine Ifosfamide Imidazole Imidurea Iminodibenzyl Imipenem Monohydrate Imipramine HCl Imiquimod

200 mg 125 mg 100 mg 70 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 50 mg 15 mg 10 mg 500 mg 200 mg 200 mg 50 mg 200 mg 200 mg 500 mg 200 mg 200 mg 500 mg 25 mg 500 mg 125 mg 10 mg 50 mg 250 mg 100 mg 100 mg 200 mg 25 mg 750 mg 3x0.2 mL 50 mg 250 mg 500 mg 200 mg 200 mg 25 mg 100 mg 200 mg 200 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

383

United States Pharmacopeia and National Formulary


Code Product Unit

USP1338324 USP1338346 USP1338357 USP1338368 USP1338801 USP1338812 USP1339000 USP1339178 USP1339189 USP1340009 USP1341001 USP1340960 USP1342004 New USP1342037 USP1342106 USP1342150 USP1342208 USP1342321 USP1342300 USP1343007 USP1343517 USP1343540

Imiquimod Related Compound A 1-Isobutyl-1H-imidazo[4,5-c]quinoline Imiquimod Related Compound C 4-Chloro-1-isobutyl-1H-imidazo[4,5-c]quinolone) Imiquimod Related Compound D 1-Propyl-1H-imidazo[4,5-c]quinolin-4-amine Imiquimod Related Compound E N4-Isobutylquinoline-3,4-diamine Indapamide Indapamide Related Compound A 4-Chloro-N-(2-methyl-indol-1-yl)-3-sulfamoylbenzamide (AS) Indigotindisulfonate Sodium Indinavir Indinavir System Suitability Indocyanine Green Indomethacin Inositol Insulin Insulin Aspart Insulin Human High Molecular Weight Insulin Human Insulin (Beef) Insulin Lispro Insulin (Pork) Iodipamide Iodixanol Iodixanol Related Compound C 5-Acetyl[3-[[3,5-bis[[2,3-dihydroxypropyl) amino]carbonyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide Iodixanol Related Compound D 5-[Acetyl(2-hydroxy-3-methylpropyl)amino]-N,N'-bis(2,3-dihydroxypropyl) 2,4,6-triiodo-1,3-benzenedicarboxamide Iodixanol Related Compound E 5-[[3-[[3-[[(2,3-Dihydoxypropyl)amino]carbonyl]-5-[[amino]carbonyl]-2,4,6triiodophenyl](acetylimino)]-2-hydroxypropyl]-(acetylimino)]-N,N'-bis(2,3-dihydoxypropyl)2,4,6-triiodo-1,3-benzenedicarboxamide o-Iodohippuric Acid Iodoquinol Iohexol Iohexol Related Compound A 5-(acetylamino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide Iohexol Related Compound B 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide Iohexol Related Compound C N,N'-bis(2,3-dihydroxypropyl)-5-nitro-1,3-benzenedicarboxamide Iopamidol Iopamidol Related Compound A N,N'Bis-(1,3-dihydroxy-2-propyl)5-amino-2,4,6-triiodoiso-phthalamide Iopamidol Related Compound B 5-Glycolamido-N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-2,4,6-triiodoisophthalamide Iopamidol Related Compound C 4-chloro-N1,N3-bis(1,3-dihydroxypropan-2-yl)-5-(S)-lactamido-2,6-diiodoisophthalamide Iopromide Iopromide Related Compound A 5-Amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methyl-1,3-benzenedicarboxamide

25 mg 25 mg 25 mg 25 mg 250 mg 50 mg 500 mg 100 mg 100 mg 200 mg 200 mg 500 mg 100 mg 7.45 mg 100 mg 8.4 mg 100 mg 5.97 mg 2x6.25mg 200 mg 200 mg 25 mg

USP1343550

50 mg

USP1343561

25 mg

USP1344305 USP1344509 USP1344600 USP1344622 USP1344644 USP1344666 USP1344702 USP1344724 USP1344735 USP1344746 USP1344804 USP1344826

100 mg 100 mg 200 mg 100 mg 50 mg 50 mg 200 mg 50 mg 50 mg 40 mg 400 mg 50 mg

384

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1344837

Iopromide Related Compound B 5-(Acetylamino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methyl-1,3benzenedicarboxamide Iothalamic Acid Ioversol Ioversol Related Compound A 5-Amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide Ioversol Related Compound B N,N'-bis(2,3-dihydroxypropyl)-5-[(N-(2-hydroxyethyl)-carbonyl)methoxy]2,4,6-triiodoisophthalamide Ioxaglic Acid Ioxilan Ioxilan Related Compound A 5-amino-2,4,6-triiodo-3 N-(2-hydroxyethyl)carbamoyl benzoic Acid Ipodate Sodium Ipratropium Bromide Ipratropium Bromide Related Compound A endo-3-Hydroxy-8-isopropyl-8-methyl-8-azoniabicyclo[3.2.1]octane bromide Ipratropium Bromide Related Compound B (1R,3r,5S,8s)-3-[[(2RS)-3-hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-(1-methylethyl)-8azoniabicyclo[3.2.1]octane, bromide Ipratropium Bromide Related Compound C (2-RS)-3-hydroxy-2-phenylpropanoic acid Irbesartan Irbesartan Related Compound A 1-pentanoylamino-cyclopentanecarboxylic acid[2'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]amide Irinotecan Hydrochloride Irinotecan Related Compound A (S)-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione Irinotecan Related Compound B (S)-4,11-diethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)dione Irinotecan Related Compound C 11-Ethyl-4-hydroxy-4-methyl-3,14-dioxo-3,4,12,14-tetrahydro-1Hpyrano[3',4':6,7]indolizino[1,2-b]quinoline-9-yl (1,4'-bipiperidine)- 1'-carboxylate hydrochloride Irinotecan Related Compound D [1,4'-Bipiperidine]-1'-carboxylic acid,4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl ester, monohydrochloride,trihydrate, (R) Irinotecan Related Compound E (S)-4,11-Diethyl-4-hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione Isoamyl Methoxycinnamate Isobutyl acetate Isocarboxazid Isoetharine HCl Isoflupredone Acetate Isoflurane Isoflurane Related Compound A 1-chloro-2,2,2-trifluoroethyl chlorodifluoromethyl ether Isoflurane Related Compound B 2,2,2-Trifluoroethyldifluoromethyl ether L-Isoleucine Isomalathion Isomalt Isomaltulose Isometheptene Mucate Isoniazid Isopropamide Iodide
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

50 mg

USP1345002 USP1345104 USP1345115 USP1345126

200 mg 200 mg 50 mg 50 mg

USP1345159 USP1345206 USP1345228 USP1347008 USP1347507 USP1347518 USP1347529

100 mg 400 mg 100 mg 200 mg 100 mg 10 mg 10 mg

USP1347530 USP1347700 USP1347711

15 mg 200 mg 25 mg

USP1347609 USP1347610 USP1347631

100 mg 10 mg 10 mg

USP1347642

10 mg

USP1347653

15 mg

New USP1347664 USP1347755 USP1347802 USP1348000 USP1348500 USP1348907 USP1349003 USP1349014 USP1349025 USP1349502 USP1349604 USP1349626 USP1349637 USP1349659 USP1349706 USP1350002
Edition 2012/2013

15 mg 750 mg 3x1.2 mL 200 mg 250 mg 200 mg 1 mL 0.1 mL 0.1 mL 200 mg 50 mg 200 mg 5g 200 mg 200 mg 200 mg
385

United States Pharmacopeia and National Formulary


Code Product Unit

USP1350104 USP1350400 USP1350603 USP1351005 USP1351107 USP1351800 USP1352008 USP1353000 USP1353102 USP1353113 USP1353500 USP1354003 USP1354207 USP1354218 USP1354251 USP1354262 USP1354309 USP1354900 USP1355006 USP1355709 USP1355753 USP1354852 USP1356009 USP1356020 USP1356508 USP1356632 USP1356643 USP1356552 USP1356563 USP1356315

Isopropyl Acetate Isopropyl Myristate Isopropyl Palmitate Isoproterenol HCl Isopteropodine Isorhamnetin Isosorbide (75% solution) Diluted Isosorbide Dinitrate Diluted Isosorbide Mononitrate Diluted Isosorbide Mononitrate Related Compound A 1,4:3,6-dianhydro-D-glucitol 2-nitrate Isotretinoin Isoxsuprine HCl Isradipine Isradipine Related Compound A Isopropyl methyl 4-(4-benzofurazanyl)-2,6-dimethyl-3,5-pyridinecarboxylate Itraconazole Itraconazole System Suitability Mixture Ivermectin Kaempferol Kanamycin Sulfate Powdered Kava Extract Kawain KDN 3-Deoxy-D-glycero-D-galacto-2-nonulosonic acid Ketamine HCl Controlled Substance CIII Ketamine Related Compound A 1-[(2-Chlorophenyl)(methylimino)methyl]cylcopentanol Ketoconazole Ketoprofen Ketoprofen Related Compound A alpha-Methyl-3-(4-methylbenzoyl) benzeneacetic Acid (AS) Ketoprofen Related Compound C (2-(3-carboxyphenyl)propionic acid) Ketoprofen Related Compound D 3-acetylbenzophenone Ketorolac Related Compound A 5-benzoyl-N-(1,3-dihydroxy-2-(hydroxymethyl)propan-2-yl)-2,3-dihydro-1H-pyrroliine-1carboxamide Ketorolac Related Compound B 5-benzoyl-2,3-dihydro-1H-pyrrolizin-1-ol Ketorolac Related Compound C 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-one Ketorolac Related Compound D 5-benzoyl-2,3-dihydro-1H-pyrrolizine Ketorolac Tromethamine Labetalol HCl Alpha-Lactalbumin Lactase Lactic Acid Lactitol Lactobionic Acid Anhydrous Lactose Lactose Monohydrate Lactulose
Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

3x1.2 mL 500 mg 500 mg 125 mg 20 mg 15 mg 1g 500 mg 350 mg 100 mg 200 mg 200 mg 200 mg 15 mg 100 mg 25 mg 200 mg 15 mg 200 mg 1g 200 mg 100 mg 250 mg 50 mg 200 mg 200 mg 25 mg 20 mg 20 mg 20 mg

USP1356326 USP1356337 USP1356348 USP1356665 USP1356654 USP1013909 USP1356698 USP1356734 USP1356687 USP1356825 USP1356676 USP1356701 USP1356803
386

20 mg 20 mg 20 mg 200 mg 200 mg 400 mg 200 mg 3x1.5 mL 500 mg 200 mg 100 mg 500 mg 750 mg
Edition 2012/2013

United States Pharmacopeia and National Formulary


Code Product Unit

USP1356836 USP1356847 USP1356858 USP1356756 USP1356778 USP1356789 USP1356790 USP1356880 USP1356905 USP1356916 USP1356927 USP1356931 New USP1357475 New USP1357486

Lamivudine Lamivudine Resolution Mixture A Lamivudine Resolution Mixture B Lamotrigine Lamotrigine Related Compound B 2,3-dichlorobenzoic acid Lamotrigine Related Compound C 3-amino-6-(2,3-dichlorophenyl)1,2,4-triazin-5(4H)-one Lamotrigine Related Compound D N-[5-amino-6-(2,3-dichlorophenyl)-1,2,4-triazin-3-yl]-2,3-dichlorobenzamide Lanolin Lanolin Alcohols Lansoprazole Lansoprazole Related Compound A 2-[[[3-methyl-4-(2,2,2-triflouroethoxy)-2-pyridyl]methyl]sulfonyl]benzimidazole Lansoprazole Related Compound B 2-[[[3-methyl-4-(2,2,2-trifluroethoxy)-pyridin-2-yl]methyl]sulfanyl]-1H-benzimidazole Latanoprost Latanoprost Related Compound A Isopropy l(E)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate Latanoprost Related Compound E (Z)-7-{(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl}-5heptenoic acid Lauric Acid Lauroyl Arginine (S)-2-dodecanamido-5-guanidinopentanoic acid HCl Lauroyl Polyoxylglycerides Leflunomide Leflunomide Related Compound A 4-trifluoromethyl)aniline Leflunomide Related Compound B 2-Cyano-3-hydroxy-N-(4'-trifluoromethylphenyl)-crotone amide Leflunomide Related Compound C N-(3'-Trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide Letrozole Letrozole Related Compound A 4,4'-(1H-1,3,4-triazol-1-ylmethylene)dibenzonitrile L-Leucine Leucovorin Calcium Leuprolide Acetate Levalbuterol HCl Levalbuterol Related Compound A 4-(2-tert-butylamino-ethyl)-2-hydroxymethyl-phenol Levalbuterol Related Compound B alpha-[{(1,1-Dimethylethyl)amino}methyl]-4-hydroxy-3-methyl-benzenemethanol Levalbuterol Related Compound C alpha-[{(1,1-Dimethylethyl)amino}methyl]-4-hydroxy-3-(methoxymethyl)-benzenemethanol Levalbuterol Related Compound D 5-[2-{(1,1-dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde benzenesulfonic acid salt Levalbuterol Related Compound E alpha-[{(1,1-Dimethylethyl)amino}methyl]-3-(ethoxy-methyl)-4-hydroxy-benzenemethanol Levalbuterol Related Compound F alpha-[{(1,1-Dimethylethyl)amino}methyl}-4-(phenylmethoxy)-1,3-benzenedimethanol Levalbuterol Related Compound G alpha[{(1,1-Dimethylethyl)amino}methyl]-4,5-dihydroxy-1,3-benzenedimethanol

200 mg 10 mg 10 mg 100 mg 20 mg 10 mg 10 mg 20 g 5g 150 mg 25 mg 25 mg 50 mg 50 mg

New USP1357533

25 mg

USP1356949 USP1356945 USP1356950 USP1356960 USP1357045 USP1357056 USP1357067 USP1356971 USP1356982 USP1357001 USP1358004 USP1358503 USP1358784 USP1358795 USP1358809 USP1358810 USP1358820

500 mg 100 mg 500 mg 200 mg 100 mg 10 mg 10 mg 200 mg 25 mg 200 mg 500 mg 200 mg 200 mg 30 mg 20 mg 30 mg 30 mg

USP1358831 USP1358842 USP1358853

30 mg 30 mg 20 mg

Edition 2012/2013

Looking for impurity reference standards with CofAs? See our LGC impurity chapter from page 11 on.

387

United States Pharmacopeia and National Formulary


Code Product Unit

USP1358864 USP1359302 USP1359404 USP1359415 USP1359426 USP1359437 USP1359506 USP1359801 USP1359856 USP1359867

Levalbuterol Related Compound H 4-[2-(tert-butylamino)-1-methoxyethyl]-2-(hydroxymethyl)phenol Levamisole HCl Levetiracetam Levetiracetam Racemic Mixture Levetiracetam Related Compound A (S)-N(1-amino-1-oxobutan-2-yl)-4-chlorobutanamide Levetiracetam Related Compound B (S)-2-aminobutanamide HCl Levmetamfetamine Controlled Substance CII Levobunolol HCl Levocabastine HCl Levocabastine Related Compound A 1-[cis-4-cyano-4-(4-fluorophenyl)cyclohexyl]-4-phenylpiperidine-4-carboxylic acid hydrochloride Levocarnitine Levocarnitine Related Compound A 2-propen-1-aminium, 3-carboxy-N,N,N-trimethyl-,chloride Levodopa Levodopa Related Compound A 3-(3,4,6-Trihydroxyphenyl)-alanine Levodopa Related Compound B 3-Methoxytyrosine Levofloxacin Levofloxacin Related Compound A (S)-9-fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3de][1,4]benzoxazine-6-carboxylic acid Levofloxacin Related Compound B (S)-9,10,difluro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6carboxylic acid Levofloxacin Related Compound C (S)-ethyl 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylate Levomenol Levonordefrin Levonorgestrel Levopropoxyphene Napsylate Levorphanol Tartrate Controlled Substance CII Levothyroxine Levothyroxine Sodium Levothyroxine for Peak Identification levothyroxine sodium spiked with liothyronine, triiodothyroacetic acid, tetraiodothyroacetic acid Lidocaine Lincomycin HCl Lindane Linoleoyl Polyoxylglycerides Liothyronine Alpha L