IP 2010
New Features of IP 2010
This new edition of the Indian Pharmacopoeia entitled 6th
edition (Indian Pharmacopoeia 2010) is published by the Indian
Pharmacopoeia Commission (IPC) in accordance with a plan
and completed through the untiring efforts of its members,
Secretariat and Laboratory over a period of about two years.
It supersedes the 2007 edition but any monograph of the earlier
edition that does not figure in this edition continues to be
official as stipulated in the Second Schedule of the Drugs and
Cosmetics Act, 1940.
Presentation
The Indian Pharmacopoeia 2010 is presented in three volumes.
Volume I contains the Notices, Preface, the Structure of the
IPC, Acknowledgements, Introduction, and the General
Chapters. Volume II contains the General Notice, General
Monographs on Dosage Forms, Monographs on drug
substances, dosage forms and pharmaceutical aids (A to M).
Volume III contains Monographs on drug substances, dosage
forms and pharmaceutical aids (N to Z) followed by
Monographs on Vaccines and Immunosera for Human use,
Herbs and Herbal products, Blood and blood-related products,
Biotechnology products and Veterinary products.
The scope of the Pharmacopoeia has been extended to include
products of biotechnology, indigenous herbs and herbal
products, veterinary vaccines and additional antiretroviral
drugs and formulations, inclusive of commonly used fixed-
dose combinations. Standards for new drugs and drugs used
under National Health Programmes are added and the
drugs as well as their formulations not in use now a days are
omitted from this edition. The number of monographs of
Excipients, Anticancer drugs, Herbal products and
Antiretroviral drugs have been increased in this edition.
Monographs of Vaccines and Immunosera are also upgraded
in view of development of latest technology in the field. A
new chapter on Liposomal products and a monograph of
Liposomal Amphotericin B injection is an added advantage in
view of latest technology adopted for drug delivery. A
chapter on NMR is incorporated in Appendices. The
chapter on microbial contamination is also updated to a
great extent to harmonise with prevailing international
requirements.
Format
In an effort to make the pharmacopoeia more user-friendly,
design of the texts of the monographs and of the test methods
are kept same. Cross-referencing has been avoided to make
each monograph complete in itself thus making it convenient
to the analyst.
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INTRODUCTION
Basis of Pharmacopoeial Requirements
As in the past, this compendium provides a publicly available
statement concerning the quality of a product that can be
expected and demonstrated at any time throughout the
accepted shelf-life of the article. The standards laid down
represent the minimum with which the article must comply
and it is inculcate on the manufacturer to ensure that the
article is manufactured in accordance with the Good
Manufacturing Practices (GMPs). It is essential that
sufficiently stringent limits are applied at the time of release of
a batch of a drug substance or drug product so that the
pharmacopoeial standards are met until its expiry date when
stored under the storage conditions specified.
It must be noted that a valid interpretation of any requirement
of the Pharmacopoeia should be done in the context of the
monograph as a whole, the relevant general monograph, where
appropriate, the specified tests and methods of analysis
including any reference to the relevant General Notices.
Familiarity with the General Notices will facilitate the correct
application of the requirements.
Changes
Keeping in view the essential requirement under the Drugs
and Cosmetics Act, 1940 and Rules thereunder in the
information on category of a drug, dosage and usual available
strengths of dosage forms has been re-kept in this edition.
General chemical tests for identification of an article have been
almost eliminated and the more specific infrared and ultraviolet
spectrophotometric tests have been given emphasis. The
concept of relying on published infrared spectra as a basis for
identification has been continued.
The use of chromatographic methods has been greatly
extended to cope with the need for more specificity in assays
and in particular, in assessing the nature and extent of
impurities in drug substances and drug products. Most of the
existing Assays and Related substances tests are upgraded
by liquid chromatography method in view to have more
specificity and to harmonise with other International
Pharmacopoeias.
The test for pyrogens involving the use of animals has been
virtually eliminated. The test for bacterial endotoxins
introduced in the previous edition is now applicable to more
items. The test for abnormal toxicity is now confined to certain
vaccines.
General Chapters
Volume I is devoted mainly to test methods that are applicable
to all the articles of the pharmacopoeia and general information
INTRODUCTION IP 2010

pertaining to the quality requirements of medicinal substances. A list of 287 new monographs items not included in the 2007
It also includes reference data such as reference spectra, edition of the Indian Pharmacopoeia and its addendum 2008
typical chromatograms etc. The test methods reflect the but added in this edition is given below:
sophistication of analytical methodology and instrumentation.
Analytical methods are, in general, in harmony with those
Admissions
adopted internationally for monitoring the quality of drugs. Monographs on drug substances, dosage forms and
The steps taken for harmonization have been initiated by the pharmaceutical aids
need to cope with the increasing demand for drugs
Acepromazine Maleate
manufactured in the country to meet globally accepted
standards. Allantoin
Aluminium Magnesium Silicate
The trend towards controlling the microbial quality of all
medicinal products has been recognized and the requirement S-Amlodipine Besylate
regarding limits of bacterial contamination even of products S-Amlodipine Tablets
for oral administration and topical application so that adequate Liposomal Amphotericin B Injection
controls are exercised by manufacturers by the adoption of Anastrozole
GMPs has been continued.
Anastrozole Tablets
The chapter on Vaccines: General requirements has been Anhydrous Lactose
updated. Minor corrections have been made in the appendices
Artesunate
entitled Tests on Chicken flocks free from specified pathogens
for the production and quality control of vaccines and General Atazanavir Sulphate
provisions: Avian viral vaccines- Tests for extraneous agents Atazanavir Capsules
in seed lot. The peptide mapping test for Inactivated Hepatitis Benzoic Acid Solution
B Vaccine has been deleted. Wherever appropriate, other Betamethasone Dipropionate
corrections have also been incorporated and overall
Betamethasone Cream
presentation improved.
Betamethasone Lotion
In view of considering the microbiological quality, the whole
Betamethasone Ointment
microbiological general chapter comprising of effectiveness
of antimicrobial preservatives, microbial contamination in Bifonazole
nonsterile products and microbiological quality of raw material, Bifonazole Cream
dosage forms, herbs, processed herbs and herbal products Bumetanide
have been extensively revised. For the first time in this chapter Bumetanide Injection
the analysis of strain Shigella boydii has been introduced
Bumetanide Oral solution
which is possibly not available in other Pharmacopoeias. The
addition of this strain Shigella boydii is essential as it Bumetanide Tablets
is acute dysentry causing strain of tropical region of our Butylparaben
country. Calcium Chloride Injection
The chapter on biotechnology derived therapeutic products Capecitabine
has been fully revised. Special emphasis has been given on Capecitabine Tablets
monoclonal antibodies Antisera. Cefamandole Nafate
Cefamandole Injection
Monographs Cetrimide Cream
The General Monographs for dosage forms of active Cetyl Palmitate
pharmaceutical ingredients (APIs) are grouped together at Chlorothiazide
the beginning of Volume II. They are followed by the Chlorothiazide Oral Suspension
monographs for the APIs, pharmaceutical aids and individual Chlorothiazide Tablets
dosage forms, all in alphabetical order. Monographs for other
Chymotrypsin
articles of a special nature such as vaccines and immunosera
for human use, herbs and herbal products, blood and blood Cilastatin Sodium
related products, biotechnology products and veterinary Clindamycin Hydrochloride
products are given in separate sections in Volume III. Clindamycin Capsules

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IP 2010 INTRODUCTION

Codeine Phosphate Tablets Felodipine Lansoprazole Sustained-release

Cyproterone Acetate Felodipine Sustained-release Tablets Capsules
Cyproterone Tablets Fenbendazole Lecithin
Daunorubicin Hydrochloride Fenofibrate Levosalbutamol Sulphate
Daunorubicin Injection Fentanyl Linezolid
Dexchlorpheniramine Maleate Fentanyl Citrate Linezolid Tablets
Dexchlorpheniramine Oral Solution Fentanyl Injection Losartan Potassium and Amlodipine
Tablets
Dexchlorpheniramine Tablets Finasteride
Losartan Potassium and
Dextropropoxyphene Hydrochloride Finasteride Tablets
Hydrochlorothiazide Tablets
Dextropropoxyphene Capsules Fluconazole
Maleic Acid
Dextropropoxyphene Napsilate Fluconazole Capsules
Malic Acid
Diacerein Fluconazole Tablets
Maltitol
Diacerein Capsules Flucytosine
Liquid Maltitol
Diazoxide Flucytosine Capsules
Maltodextrin
Diazoxide Tablets Flucytosine Oral Suspension
Mefloquine Hydrochloride
Dicloxacillin Sodium Flucytosine Tablets
Meloxicam Oral Suspension
Dicloxacillin Capsules Fluorescein Injection
Menthol and Benzoin Inhalation
Flutamide
Dicloxacillin Oral Suspension Metformin Hydrochloride Sustained-
Flutamide Capsules release Tablets
Diethanolamine
Fumaric Acid Methadone Linctus
Dihydroergocristine Mesylate
Gefitinib Metronidazole Sterile Suspension
Dihydroergotamine Mesylate
Gefitinib Tablets Miconazole
Dimethicone
Gemifloxacin Mesylate Microcrystalline Cellulose and
Disopyramide
Gemifloxacin Tablets Carboxymethylcellulose Sodium
Disopyramide Capsules
Gliclazide Misoprostol
Disopyramide Phosphate Capsules
Gliclazide Tablets Mometasone Furoate
Disopyramide Phosphate Sustained-
Glimepiride Mometasone Aqueous Nasal Spray
release Capsules
Glimepiride Tablets Mometasone Cream
Divalproex Sustained-release Tablets
Homatropine Methylbromide Mometasone Ointment
Docetaxel Trihydrate
Homatropine Methylbromide Tablets Montelukast Sodium
Docetaxel Injection
Hyoscyamine Sulphate Montelukast Tablets
Domperidone
Hyoscyamine Injection Mycophenolate Mofetil
Doxofylline
Hyoscyamine Oral Solution Mycophenolate Mofetil Capsules
Doxofylline Tablets
Hyoscyamine Tablets Myristic Acid
Enoxaparin Sodium
Ibuprofen Cream Naloxone Hydrochloride
Enoxaparin Injection
Ibuprofen Gel Naloxone Injection
Escitalopram Oxalate Naltrexone Hydrochloride
Imatinib Mesylate
Escitalopram Tablets Naltrexone Tablets
Imatinib Capsules
Estradiol and Norethisterone Tablets Indapamide Tablets Naproxen
Etodolac Isobutane Naproxen Oral Suspension
Etodolac Capsules Isopropyl Myristate Naproxen Suppositories
Etodolac Tablets Lactulose Naproxen Sustained-release Tablets
Famotidine Lamotrigine Sustained-release Tablets Naproxen Tablets
Famotidine Tablets Lansoprazole Neotame

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INTRODUCTION IP 2010

Ondansetron Orally Disintegrating Ribavirin Valsartan Tablets

Tablets Ribavirin Inhalation Solution Valsartan and Hydrochlorothiazide
Ondansetron Oral Solution Serratiopeptidase Tablets
Pantoprazole Sodium Serratiopeptidase Tablets Vancomycin Hydrochloride
Pantoprazole Sustained-release Tablets Sildenafil Citrate Vancomycin Capsules
Perphenazine Sildenafil Tablets Vancomycin Intravenous Infusion
Perphenazine Tablets Simvastatin Vancomycin Oral Solution
Phenoxyethanol Simvastatin Tablets Xanthan Gum
Phenylpropanolamine Hydrochloride Sorbitan Oleate Zoledronic Acid
Phenytoin Sucralose Zoledronic Acid Injection
Phenytoin Capsules Sumatriptan
Phenytoin Oral Suspension Herbal Monographs
Sumatriptan Injection
Pimozide Amla Juice Powder
Telmisartan
Pimozide Tablets Arjuna Dry Extract
Telmisartan Tablets
Piperacillin Ashwagandha Dry Extract
Temozolomide
Piperacillin Intravenous Infusion Belladonna Tincture
Temozolomide Capsules
Poloxamers Bhibhitaki Aqueous Extract
Terazosin Hydrochloride
Polyoxyl 35 Castor Oil Brahmi Extract
Thiocolchicoside
Polyoxyl 40 Hydrogenated Castor Oil Coconut Oil
Thiocolchicoside Capsules
Potassium Sorbate Coleus Dry Extract
Ticarcillin and Clavulanic Acid
Pravastatin Sodium Injection Coriander Oil
Pravastatin Tablets Tolazamide Garcinia Aqueous Extract
Praziquantel Tolazamide Tablets Haridra Dry Extract
Praziquantel Tablets Tolnaftate Haritaki Extract
Prednisolone Acetate Tolnaftate Cream Haritaki Aqueous Extract
Pregabalin Tolnaftate Gel Ipecac Tincture
Pregabalin Capsules Tolnaftate Topical Powder Lavang
Pregelatinised Starch Tolnaftate Topical Solution Methi
Progesterone Injectable Suspension Tolterodine Tartrate Neem
Promazine Tablets Tramadol Hydrochloride Sarpagandha Powder
Propane Tramadol Capsules Sarpagandha Tablets
Propionic Acid Trandolapril Sunthi Extract
Propofol Trandolapril Tablets Tulasi Dry Extract
Propofol Injection Travoprost Vasaka Extract
Protriptyline Hydrochloride Travoprost Eye drops
Veterinary Monographs
Protriptyline Tablets Tributyl Citrate
Pyrimethamine Tablets Infectious Bursal Disease Vaccine ,
Trichloromonofluoromethane
Quiniodochlor Cream Live
Triethyl Citrate
Quiniodochlor Ointment Infectious Chicken Aneamia Vaccine,
Trimetazidine Hydrochloride Inactivated
Quiniodochlor and Hydrocortisone Valproate Injection
Cream Infectious Chicken Aneamia Vaccine,
Valproic Acid Live
Quiniodochlor and Hydrocortisone
Valproic Acid Capsules Marek’s Disease Vaccine, Live
Ointment
Ramipril and Hydrochlorothiazide Valproic Acid Oral Solution Reo Virus Vaccine, Inactivated
Tablets Valsartan Reo Virus Vaccine, Live

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IP 2010
Salmonella Vaccine, Inactivated Carbimazole
Sterile Diluent for Live Vaccines Carvedilol Tablets
Cefadroxil
Monographs upgraded Crospovidone
Monographs on drug substances, dosage Cefuroxime Injection
forms and pharmaceutical aids Cefaclor Oral suspension
Acarbose Cefadroxil Capsules
Aciclovir Cefotaxime Sodium
Adrenaline Injection Cefazolin Sodium
Alprazolam Cefixime
Alprazolam Tablets Cinnarizine
Aminophylline Cefaperazone Sodium
Aminophylline Injection Cefazolin Injection
Aminophylline Tablets Cimetidine Tablets
Amitriptyline Hydrochloride Cephalexin
Amodiaquine Tablets Cetostearyl Alcohol
Arginine Cetyl Alcohol
Arteether
Carbimazole Tablets
Artemether
Cefadroxil Tablets
Artemesinin
Chlordiazepoxide
Atorvastatin Calcium
Cisplatin
Azithromycin
Clopidogrel Bisulphate
Azithromycin Oral Suspension Clopidogrel Tablets
Azithromycin Tablets Clotrimazole Cream
Bacitracin Cresol with Soap Solution
Bacitracin Zinc Cytarabine
Benzyl alcohol Danazol
Bromhexine Hydrochloride Danazol Capsules
Bromhexine Tablets Desferrioxamine Mesylate
Bromocriptine Mesylate Desferrioxamine Injection
Bromocriptine Capsules Dexamethasone Sodium phosphate
Bromocriptine Tablets Dextromethorphan Hydrobromide
Bisacodyl Dibutyl Phthalate
Bisacodyl Tablets Dicyclomine Injection
Buprenorphine Hydrochloride Digoxin
Benzhexol Hydrochloride Disodium Edetate
Calcium Gluconate Tablets Diphenhydramine Hydrochloride
Calcium Levulinate Erythromycin Estolate
Calcium Stearate Esomeprazole Magnesium Trihydrate
Captopril Esomeprazole Tablets
Citric Acid Ethambutol Hydrochloride
Citric Acid Monohydrate Ferrous Gluconate
Cellulose Acetate Phthalate Ferrous Sulphate
Clofazimine Capsules Dried Ferrous Sulphate
v
INTRODUCTION
Fexofenadine Hydrochloride
Fluocinolone Acetonide
Fluorescein Injection
Folic Acid
Frusemide
Frusemide Injection
Frusemide Tablets
Gallamine Triethiodide
Gallamine Injection
Gentamycin Sulphate
Glibenclamide
Glibenclamide Tablets
Guaiphenesin
Heparin Sodium
Heparin Injection
Ibuprofen
Ibuprofen Tablets
Imipenem
Imipenem and Cilastatin Injection
Isoxsuprine Hydrochloride
Ketamine Hydrochloride
Ketamine Injection
Ketonazole
Ketonazole Tablets
Ketoprofen
Ketoprofen Capsules
Lactose
Levamisole Tablets
Levocitrizine Hydrochloride
Levocetirizine Tablets
Levofloxacin Tablets
Magnesium Stearate
Magnesium Trisilicate
Mannitol
Mannitol Injection
Mebendazole
Mebendazole Tablets
Megestrol Acetate
Mercaptopurine
Methotrexate Injection
Methylergometrine Tablets
Metronidazole
Metronidazole Tablets
Metronidazole Injection
Morphine Sulphate
INTRODUCTION IP 2010

Mosapride Citrate Dihydrate Rabeprazole Tablets Monographs on Vaccines for Human

Naphazoline Nitrate Riboflavine Sodium Phosphate Use
Nebivolol Hydrochloride Ritonavir Tablets Diphtheria and Tetanus Vaccine
Nebivolol Tablets Salbutamol (Adsorbed) for Adults and
Nefedipine Sustained- release Tablets Salbutamol Sulphate Adolescents
Niclosamide Salbutamol Injection Diphtheria, Tetanus and Pertussis
Niclosamide Tablets Salmeterol and Fluticasone Propionate Vaccine (Adsorbed)
Nitrazepam Powder for Inhalation Diphtheria, Tetanus, Pertussis (Whole
Secnidazole Cell), Hepatitis B (rDNA) and
Nitrazepam Tablets
Haemophilus Type b Conjugate
Nitrofurazone Sodium Alginate
Vaccine (Adsorbed)
Norethisterone Sorbitol
Hepatitis B Vaccine (rDNA)
Noscapine Soritol Solution (70 per cent)
(Crystallizing) Measles, Mumps and Rubella Vaccine
Nystatin (Live)
Soritol Solution (70 per cent) (Non-
Ofloxacin Tetanus Vaccine (Adsorbed)
crystallizing)
Olanzapine
Spironolactone
Omeprazole Monographs on Vaccines for Veterinary
Spironolactone Tablets Use
Ondansetron Tablets Sodium Fusidate
Oxytocin Avian Infectious Bronchitis Vaccine,
Sodium Fusidate Capsules Inactivated
Oxytocin Injection Sodium Propylparaben Avian Infectious Bronchitis Vaccine,
Oxytocin Nasal Solution Sodium Methylparaben Live
Phenobarbitone Methylparaben Avian Spirochaetosis Vaccine
Phenobarbitone Sodium Propylparaben Egg Drop Syndrome’76 (Adenovirus)
Paracetamol Stearyl Alcohol Vaccine, Inactivated
Paracetamol Tablets Sucrose Foot-and-Mouth Disease Vaccine,
Diluted Pentaerythritol Tetranitrate Sulphacetamide Sodium Inactivated
Pentamidine Isethionate Sulphacetamide Eye drops Fowl Cholera Vaccine, Inactivated
Pentamidine Injection Talc Fowl Pox Vaccine, Live
Pethidine Hydrochloride Terbutaline Tablets Inclusion Body Hepatitis (IBH)
Pethidine Injection Theophylline Vaccine, Inactivated
Phenolphthalein Theophylline Tablets Infectious Avian Encephalomyelitis
Phenylbutazone Thiamine Hydrochloride Vaccine, Live
Piracetam Thiamine Nitrate Infectious Bursal Disease Vaccine,
Piroxicam Tenofovir and Emtricitabine Tablets Inactivated
Polysorbate 20 Terbutaline Sulphate Infectious Coryza Vaccine
Polysorbate 80 Thiotepa Peste Des Petits Ruminants Vaccine,
Potassium Iodide Topiramate Tablets Live
Povidone Verapamil Hydrochloride Ranikhet Disease Vaccine, Inactivated
Prednisolone Verapamil Tablets Ranikhet Disease Vaccine, Live
Propranolol Hydrochloride Vessopressin Injection (Lentogenic Strain)
Propranolol Injection Vincristine Sulphate Ranikhet Disease Vaccine, Live
Propranolol Tablets Vincristine Injection (Mesogenic Strain)
Pseudoephedrine Hydrochloride Xylometazoline Hydrochloride
Monographs on Veterinary Diagnostics
Pyrantel Pamoate Warfarin Sodium
Quetiapine Fumarate Warfarin Sodium Clatharate Avian Mycoplasma Antigen
Quinine Dihydrochloride Injection Zidovudine Tablets Salmonella Pullorum Antigen

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IP 2010
Changed Titles of Monographs Dibutyl Phthalate
From ‘Leptospira Veterinary Vaccine, Emetine Hydrochloride
Inactivated’ to ‘ Canine Leptospirosis Emetine Injection
Vaccine, Inactivated’ Ephedrine
From ‘Avian Pleuropneumonia Live Erythromycin Estolate
Antigen’ to ‘ Avian Mycoplasma Erythromycin Estolate Tablets
Antigen’ Fusidic Acid Oral Solution
From ‘Salmonella Pullorum Coloured 2- Deoxy- D- Glucose
Antigen’ to ‘Salmonella Pullorum
Protamine Zinc Insulin Injection
Antigen’
Lanatoside C
Lanatoside C Tablets
Omissions
Laryngotracheitis Vaccine, Live
Adenine Menadione
Aluminium Sulphate Methdilazine Hydrochloride
Analgin Methdilazine Tablets
Analgin Tablets Oxyphenbutazone
Butylated Hydroxyanisole Oxyphenbutazone Tablets
Caramel Phenindamine Tartrate
Cyclopropane Phenindamine Tablets
Deslanoside Phenylbutazone
Deslanoside Injection Phenylbutazone Tablets
vii
INTRODUCTION
Propantheline Bromide
Propantheline Tablets
Sodium Aurothiomalate
Sodium Aurothiomalate Injection
Sodium Cromoglycate
Sodium Cromoglycate Powder for
Inhalation
Sodium Fusidate Capsules
Prepared Storax
Sulphadimethoxine
Sulphadimethoxine Tablets
Sulphadimidine
Sulphadimidine Sodium
Sulphadimidine Injection
Sulphadimidine Tablets
Sulphafurazole
Sulphafurazole Tablets
Sulphalene
Sulphaphenazole
Sulphaphenazole Tablets
Sulphobromophthalein Sodium
Sulphobromophthalein Sodium
Injection