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EUROPEAN PHARMACOPOEIA 5.

INDEX
To aid users the index includes a reference to the supplement where the latest version of a text can be found.
For example: Acetone...............................................5.1-2875
means the monograph Acetone can be found on page 2875 of Supplement 5.1.
Note that where no reference for a supplement is made, the text can be found in the principal volume.

General Notices (1) apply to all monographs and other texts 3045
EUROPEAN PHARMACOPOEIA 5.1 Index

Numerics 2.2.56. Amino acid analysis ....................................................... 86


1.1. General statements.................................................................5 2.2.5. Relative density................................................................. 27
1.2. Other provisions applying to general chapters and 2.2.6. Refractive index ................................................................ 28
monographs ...................................................................................5 2.2.7. Optical rotation ................................................................. 28
1.3. General chapters .....................................................................6 2.2.8. Viscosity.............................................................................. 29
1.4. Monographs .............................................................................7 2.2.9. Capillary viscometer method ......................................... 29
1.5. Abbreviations and symbols...................................................9 2.2. Physical and physicochemical methods.......................... 23
1.6. Units of the International System (SI) used in the 2.3.1. Identification reactions of ions and functional
Pharmacopoeia and equivalence with other units..............10 groups .......................................................................................... 95
1,8-Cineole in essential oils, assay of (2.8.11.) ......................216 2.3.2. Identification of fatty oils by thin-layer
1. General notices ...........................................................................5 chromatography......................................................................... 98
2.1.1. Droppers..............................................................................17 2.3.3. Identification of phenothiazines by thin-layer
2.1.2. Comparative table of porosity of sintered-glass chromatography......................................................................... 99
filters..............................................................................................17 2.3.4. Odour .................................................................................. 99
2.1.3. Ultraviolet ray lamps for analytical purposes..............17 2.3. Identification......................................................................... 95
2.1.4. Sieves ...................................................................................18 2.4.10. Lead in sugars............................................................... 107
2.1.5. Tubes for comparative tests ............................................19 2.4.11. Phosphates..................................................................... 108
2.1.6. Gas detector tubes.............................................................19 2.4.12. Potassium....................................................................... 108
2.1. Apparatus ...............................................................................17 2.4.13. Sulphates ....................................................................... 108
2.2.10. Rotating viscometer method ....................................... 30 2.4.14. Sulphated ash ............................................................... 108
2.2.11. Distillation range ............................................................ 30 2.4.15. Nickel in polyols ........................................................... 108
2.2.12. Boiling point ....................................................................31 2.4.16. Total ash......................................................................... 108
2.2.13. Determination of water by distillation....................... 32 2.4.17. Aluminium...................................................................... 108
2.2.14. Melting point - capillary method................................. 32 2.4.18. Free formaldehyde ....................................................... 109
2.2.15. Melting point - open capillary method ...................... 33 2.4.19. Alkaline impurities in fatty oils ................................. 109
2.2.16. Melting point - instantaneous method ...................... 33 2.4.1. Ammonium....................................................................... 103
2.2.17. Drop point ........................................................................ 33 2.4.21. Foreign oils in fatty oils by thin-layer
2.2.18. Freezing point................................................................. 34 chromatography....................................................................... 109
2.2.19. Amperometric titration ................................................. 34 2.4.22. Composition of fatty acids by gas
2.2.1. Clarity and degree of opalescence of liquids.............. 23 chromatography........................................................................110
2.2.20. Potentiometric titration ................................................ 35 2.4.23. Sterols in fatty oils ..............................................5.1-2787
2.2.21. Fluorimetry...................................................................... 35 2.4.24. Identification and control of residual solvents...... 113
2.2.22. Atomic emission spectrometry.................................... 35 2.4.25. Ethylene oxide and dioxan..........................................118
2.2.23. Atomic absorption spectrometry ................................ 36 2.4.26. N,N-Dimethylaniline .....................................................119
2.2.24. Absorption spectrophotometry, infrared .................. 37 2.4.27. Heavy metals in herbal drugs and fatty oils............119
2.2.25. Absorption spectrophotometry, ultraviolet and 2.4.28. 2-Ethylhexanoic acid ................................................... 120
visible............................................................................................ 38 2.4.29. Composition of fatty acids in oils rich in
2.2.26. Paper chromatography ................................................. 40 omega-3-acids............................................................................ 121
2.2.27. Thin-layer chromatography .......................................... 40 2.4.2. Arsenic .............................................................................. 103
2.2.28. Gas chromatography ..................................................... 42 2.4.30. Ethylene glycol and diethylene glycol in ethoxylated
2.2.29. Liquid chromatography ................................................ 43 substances ................................................................................. 122
2.2.2. Degree of coloration of liquids...................................... 24 2.4.3. Calcium............................................................................. 103
2.2.30. Size-exclusion chromatography .................................. 45 2.4.4. Chlorides .......................................................................... 104
2.2.31. Electrophoresis ............................................................... 45 2.4.5. Fluorides .......................................................................... 104
2.2.32. Loss on drying ................................................................ 50 2.4.6. Magnesium....................................................................... 104
2.2.33. Nuclear magnetic resonance spectrometry ...............51 2.4.7. Magnesium and alkaline-earth metals ....................... 104
2.2.34. Thermal analysis............................................................. 52 2.4.8. Heavy metals ................................................................... 104
2.2.35. Osmolality ........................................................................ 54 2.4.9. Iron .................................................................................... 107
2.2.36. Potentiometric determination of ionic 2.4. Limit tests............................................................................ 103
concentration using ion-selective electrodes....................... 55 2.5.10. Oxygen-flask method................................................... 130
2.2.37. X-ray fluorescence spectrometry................................. 56 2.5.11. Complexometric titrations.......................................... 130
2.2.38. Conductivity .........................................................5.1-2783 2.5.12. Water: semi-micro determination ............................. 130
2.2.39. Molecular mass distribution in dextrans .................. 57 2.5.13. Aluminium in adsorbed vaccines...............................131
2.2.3. Potentiometric determination of pH ............................ 26 2.5.14. Calcium in adsorbed vaccines ....................................131
2.2.40. Near-infrared spectrophotometry ............................... 59 2.5.15. Phenol in immunosera and vaccines ........................131
2.2.41. Circular dichroism.......................................................... 63 2.5.16. Protein in polysaccharide vaccines ...........................131
2.2.42. Density of solids ............................................................. 64 2.5.17. Nucleic acids in polysaccharide vaccines ................ 132
2.2.43. Mass spectrometry ......................................................... 65 2.5.18. Phosphorus in polysaccharide vaccines.................. 132
2.2.44. Total organic carbon in water for pharmaceutical 2.5.19. O-Acetyl in polysaccharide vaccines......................... 132
use................................................................................................. 68 2.5.1. Acid value......................................................................... 127
2.2.45. Supercritical fluid chromatography........................... 68 2.5.20. Hexosamines in polysaccharide vaccines................ 132
2.2.46. Chromatographic separation techniques.................. 69 2.5.21. Methylpentoses in polysaccharide vaccines ........... 133
2.2.47. Capillary electrophoresis ...............................................74 2.5.22. Uronic acids in polysaccharide vaccines ................. 133
2.2.48. Raman spectrometry ..................................................... 79 2.5.23. Sialic acid in polysaccharide vaccines ..................... 133
2.2.49. Falling ball viscometer method................................... 80 2.5.24. Carbon dioxide in gases.............................................. 134
2.2.4. Relationship between reaction of solution, 2.5.25. Carbon monoxide in gases......................................... 134
approximate pH and colour of certain indicators .............. 27 2.5.26. Nitrogen monoxide and nitrogen dioxide in
2.2.54. Isoelectric focusing.........................................................81 gases ........................................................................................... 135
2.2.55. Peptide mapping............................................................. 82 2.5.27. Oxygen in gases ............................................................ 136

General Notices (1) apply to all monographs and other texts 3047
Index EUROPEAN PHARMACOPOEIA 5.1

2.5.28. Water in gases............................................................... 136 2.7.8. Assay of tetanus vaccine (adsorbed)..................5.1-2791


2.5.29. Sulphur dioxide ............................................................ 136 2.7.9. Test for Fc function of immunoglobulin ................... 202
2.5.2. Ester value ....................................................................... 127 2.7. Biological assays ................................................................ 187
2.5.30. Oxidising substances................................................... 137 2.8.10. Solubility in alcohol of essential oils ........................216
2.5.31. Ribose in polysaccharide vaccines............................ 137 2.8.11. Assay of 1,8-cineole in essential oils .........................216
2.5.32. Water: micro determination ...................................... 137 2.8.12. Determination of essential oils in vegetable
2.5.33. Total protein.................................................................. 138 drugs............................................................................................217
2.5.34. Acetic acid in synthetic peptides ...............................141 2.8.13. Pesticide residues..........................................................218
2.5.35. Nitrous oxide in gases..................................................141 2.8.14. Determination of tannins in herbal drugs .............. 221
2.5.36. Anisidine value ............................................................. 142 2.8.15. Bitterness value ............................................................ 221
2.5.3. Hydroxyl value ................................................................ 127 2.8.16. Dry residue of extracts................................................ 222
2.5.4. Iodine value ..................................................................... 127 2.8.17. Loss on drying of extracts .......................................... 222
2.5.5. Peroxide value................................................................. 128 2.8.1. Ash insoluble in hydrochloric acid ............................. 215
2.5.6. Saponification value ...................................................... 129 2.8.2. Foreign matter ................................................................ 215
2.5.7. Unsaponifiable matter ................................................... 129 2.8.3. Stomata and stomatal index ........................................ 215
2.5.8. Determination of primary aromatic 2.8.4. Swelling index ................................................................. 215
amino-nitrogen ......................................................................... 129 2.8.5. Water in essential oils.....................................................216
2.5.9. Determination of nitrogen by sulphuric acid 2.8.6. Foreign esters in essential oils .....................................216
digestion .................................................................................... 129 2.8.7. Fatty oils and resinified essential oils in essential
2.5. Assays ................................................................................... 127 oils................................................................................................216
2.6.10. Histamine ....................................................................... 153 2.8.8. Odour and taste of essential oils..................................216
2.6.11. Depressor substances.................................................. 153 2.8.9. Residue on evaporation of essential oils....................216
2.6.12. Microbiological examination of non-sterile products 2.8. Methods in pharmacognosy ............................................ 215
(total viable aerobic count).................................................... 154 2.9.10. Ethanol content and alcoholimetric tables ............ 237
2.6.13. Microbiological examination of non-sterile products 2.9.11. Test for methanol and 2-propanol ............................ 239
(test for specified micro-organisms)..................................... 156 2.9.12. Sieve test ........................................................................ 239
2.6.14. Bacterial endotoxins .....................................................161 2.9.13. Limit test of particle size by microscopy................. 239
2.6.15. Prekallikrein activator................................................. 168 2.9.14. Specific surface area by air permeability ................ 239
2.6.16. Tests for extraneous agents in viral vaccines for 2.9.15. Apparent volume .......................................................... 241
human use................................................................................. 169 2.9.16. Flowability...................................................................... 242
2.6.17. Test for anticomplementary activity of 2.9.17. Test for extractable volume of parenteral
immunoglobulin....................................................................... 170 preparations.............................................................................. 243
2.6.18. Test for neurovirulence of live virus vaccines........ 172 2.9.18. Preparations for inhalation : aerodynamic assessment
2.6.19. Test for neurovirulence of poliomyelitis vaccine of fine particles ...............................................................5.1-2799
(oral) ........................................................................................... 172 2.9.19. Particulate contamination : sub-visible particles... 253
2.6.1. Sterility ............................................................................. 145 2.9.1. Disintegration of tablets and capsules....................... 225
2.6.20. Anti-A and anti-B haemagglutinins 2.9.20. Particulate contamination : visible particles.......... 255
(indirect method) ......................................................................174 2.9.22. Softening time determination of lipophilic
2.6.21. Nucleic acid amplification techniques ......................174 suppositories............................................................................. 256
2.6.22. Activated coagulation factors .................................... 177 2.9.23. Pycnometric density of solids.................................... 257
2.6.24. Avian viral vaccines : tests for extraneous agents in 2.9.24. Resistance to rupture of suppositories and
seed lots ..................................................................................... 177 pessaries .................................................................................... 258
2.6.25. Avian live virus vaccines : tests for extraneous agents 2.9.25. Chewing gum, medicated, drug release from ........ 260
in batches of finished product .............................................. 180 2.9.26. Specific surface area by gas adsorption......... 5.1-2811
2.6.2. Mycobacteria ................................................................... 149 2.9.27. Uniformity of mass of delivered doses from multidose
2.6.7. Mycoplasmas.................................................................... 149 containers.................................................................................. 263
2.6.8. Pyrogens........................................................................... 152 2.9.28. Test for deliverable mass or volume of liquid and
2.6.9. Abnormal toxicity ........................................................... 153 semi-solid preparations........................................................... 263
2.6. Biological tests ................................................................... 145 2.9.2. Disintegration of suppositories and pessaries ......... 227
2.7.10. Assay of human coagulation factor VII ................... 203 2.9.3. Dissolution test for solid dosage forms ..................... 228
2.7.11. Assay of human coagulation factor IX ..................... 204 2.9.4. Dissolution test for transdermal patches .................. 231
2.7.12. Assay of heparin in coagulation factors .................. 204 2.9.5. Uniformity of mass of single-dose preparations....... 233
2.7.13. Assay of human anti-D immunoglobulin................. 205 2.9.6. Uniformity of content of single-dose preparations.. 234
2.7.14. Assay of hepatitis A vaccine ..............................5.1-2795 2.9.7. Friability of uncoated tablets ....................................... 234
2.7.15. Assay of hepatitis B vaccine (rDNA)......................... 207 2.9.8. Resistance to crushing of tablets................................ 235
2.7.16. Assay of pertussis vaccine (acellular)....................... 208 2.9.9. Measurement of consistency by penetrometry ........ 235
2.7.17. Assay of human antithrombin III .............................. 209 2.9. Pharmaceutical technical procedures ........................... 225
2.7.18. Assay of human coagulation factor II ...................... 209 2-Ethylhexanoic acid (2.4.28.) ................................................. 120
2.7.19. Assay of human coagulation factor X .......................210 2-Propanol and methanol, test for (2.9.11.).......................... 239
2.7.1. Immunochemical methods ........................................... 187 3.1.10. Materials based on non-plasticised poly(vinyl chloride)
2.7.20. In vivo assay of poliomyelitis vaccine for containers for non-injectable, aqueous solutions ...... 289
(inactivated) ...............................................................................210 3.1.11. Materials based on non-plasticised poly(vinyl
2.7.21. Assay of human von Willebrand factor.....................211 chloride) for containers for dry dosage forms for oral
2.7.22. Assay of human coagulation factor XI..................... 212 administration .......................................................................... 291
2.7.2. Microbiological assay of antibiotics............................ 188 3.1.1.1. Materials based on plasticised poly(vinyl chloride) for
2.7.4. Assay of human coagulation factor VIII .................... 194 containers for human blood and blood components....... 269
2.7.5. Assay of heparin.............................................................. 195 3.1.1.2. Materials based on plasticised poly(vinyl chloride)
2.7.6. Assay of diphtheria vaccine (adsorbed) ..................... 196 for tubing used in sets for the transfusion of blood and
2.7.7. Assay of pertussis vaccine............................................. 197 blood components ................................................................... 272

3048 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

3.1.13. Plastic additives ............................................................ 293 5.2.5. Substances of animal origin for the production of
3.1.14. Materials based on plasticised poly(vinyl chloride) veterinary vaccines.................................................................. 460
for containers for aqueous solutions for intravenous 5.2.6. Evaluation of safety of veterinary vaccines and
infusion ...................................................................................... 296 immunosera ....................................................................5.1-2827
3.1.15. Polyethylene terephthalate for containers for 5.2.7. Evaluation of efficacy of veterinary vaccines and
preparations not for parenteral use..................................... 298 immunosera .....................................................................5.1-2829
3.1.1. Materials for containers for human blood and blood 5.2.8. Minimising the risk of transmitting animal spongiform
components............................................................................... 269 encephalopathy agents via human and veterinary medicinal
3.1.3. Polyolefines...................................................................... 274 products ..................................................................................... 463
3.1.4. Polyethylene without additives for containers 5.2.9. Evaluation of safety of each batch of veterinary
for parenteral preparations and for ophthalmic vaccines and immunosera.............................................5.1-2830
preparations.............................................................................. 278 5.2. General texts on vaccines................................................. 453
3.1.5. Polyethylene with additives for containers 5.3. Statistical analysis of results of biological assays and
for parenteral preparations and for ophthalmic tests............................................................................................. 475
preparations.............................................................................. 279 5.4. Residual solvents ............................................................... 507
3.1.6. Polypropylene for containers and closures for 5.5. Alcoholimetric tables .........................................................519
parenteral preparations and ophthalmic preparations ... 282 5.6. Assay of interferons........................................................... 533
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing 5.7. Table of physical characteristics of radionuclides
for total parenteral nutrition preparations ........................ 285 mentioned in the European Pharmacopoeia..................... 539
3.1.8. Silicone oil used as a lubricant ................................... 287 5.8. Pharmacopoeial harmonisation ..................................... 551
3.1.9. Silicone elastomer for closures and tubing .............. 288 5.9. Polymorphism..................................................................... 555
3.1. Materials used for the manufacture of containers ..... 269
3.2.1. Glass containers for pharmaceutical use .................. 303 A
3.2.2.1. Plastic containers for aqueous solutions for Abbreviations and symbols (1.5.).................................................9
parenteral infusion .................................................................. 309 Abnormal toxicity (2.6.9.)......................................................... 153
3.2.2. Plastic containers and closures for pharmaceutical Absinthii herba ........................................................................ 2710
use............................................................................................... 308 Absorption spectrophotometry, infrared (2.2.24.)................ 37
3.2.3. Sterile plastic containers for human blood and blood Absorption spectrophotometry, ultraviolet and visible
components............................................................................... 309 (2.2.25.) ........................................................................................ 38
3.2.4. Empty sterile containers of plasticised poly(vinyl Acacia............................................................................................ 905
chloride) for human blood and blood components...........311 Acaciae gummi .......................................................................... 905
3.2.5. Sterile containers of plasticised poly (vinyl chloride) Acaciae gummi dispersione desiccatum............................. 905
for human blood containing anticoagulant solution....... 312 Acacia, spray-dried ..................................................................... 905
3.2.6. Sets for the transfusion of blood and blood Acamprosate calcium ................................................................ 906
components................................................................................313 Acamprosatum calcicum......................................................... 906
3.2.8. Sterile single-use plastic syringes ................................314 Acarbose..............................................................................5.1-2873
3.2.9. Rubber closures for containers for aqueous parenteral Acarbosum .........................................................................5.1-2873
preparations, for powders and for freeze-dried powders ..316 Acebutolol hydrochloride......................................................... 907
3.2. Containers ........................................................................... 303 Acebutololi hydrochloridum .................................................. 907
4.1.1. Reagents ........................................................................... 321 Aceclofenac.................................................................................. 909
4.1.1. Reagents .................................................................. 5.1-2817 Aceclofenacum........................................................................... 909
4.1.2. Standard solutions for limit tests................................ 426 Acesulfame potassium ...............................................................911
4.1.2. Standard solutions for limit tests....................... 5.1-2818 Acesulfamum kalicum ..............................................................911
4.1.3. Buffer solutions .............................................................. 430 Acetazolamide............................................................................. 912
4.1. Reagents, standard solutions, buffer solutions ........... 321 Acetazolamidum........................................................................ 912
4.2.1. Primary standards for volumetric solutions............. 435 Acetic acid, glacial ......................................................................913
4.2.2. Volumetric solutions...................................................... 435 Acetic acid in synthetic peptides (2.5.34.) .............................141
4.2. Volumetric analysis............................................................ 435 Acetone................................................................................5.1-2875
4-Aminobenzoic acid ................................................................. 973 Acetonum ...........................................................................5.1-2875
4. Reagents.................................................................................. 321 Acetylcholine chloride ...............................................................914
5.10. Control of impurities in substances for pharmaceutical Acetylcholini chloridum...........................................................914
use............................................................................................... 559 Acetylcysteine ..............................................................................915
5.11. Characters section in monographs .............................. 565 Acetylcysteinum .........................................................................915
5.1.1. Methods of preparation of sterile products .............. 445 Acetylsalicylic acid ......................................................................917
5.1.2. Biological indicators of sterilisation........................... 447 Acetyltryptophan, N- ..................................................................918
5.1.3. Efficacy of antimicrobial preservation ....................... 447 Acetyltyrosine, N- ....................................................................... 920
5.1.4. Microbiological quality of pharmaceutical Aciclovir ....................................................................................... 921
preparations.............................................................................. 449 Aciclovirum ................................................................................ 921
5.1.5. Application of the F0 concept to steam sterilisation of Acidum 4-aminobenzoicum ................................................... 973
aqueous preparations ....................................................5.1-2821 Acidum aceticum glaciale........................................................913
5.1. General texts on sterility .................................................. 445 Acidum acetylsalicylicum ........................................................917
5.2.1. Terminology used in monographs on vaccines ....... 453 Acidum adipicum...................................................................... 926
5.2.2. Chicken flocks free from specified pathogens for the Acidum alginicum..................................................................... 942
production and quality control of vaccines...............5.1-2825 Acidum amidotrizoicum dihydricum .................................. 967
5.2.3. Cell substrates for the production of vaccines for Acidum aminocaproicum ....................................................... 974
human use................................................................................. 455 Acidum ascorbicum................................................................ 1025
5.2.4. Cell cultures for the production of veterinary Acidum asparticum ................................................................ 1029
vaccines...................................................................................... 458 Acidum benzoicum................................................................. 1072
Acidum boricum.......................................................................1117

General Notices (1) apply to all monographs and other texts 3049
Index EUROPEAN PHARMACOPOEIA 5.1

Acidum caprylicum ................................................................ 1172 Aer medicinalis.......................................................................... 929


Acidum chenodeoxycholicum..............................................1247 Aer medicinalis artificiosus ................................................... 932
Acidum citricum anhydricum .............................................1306 Aerodynamic assessment of fine particles in preparations for
Acidum citricum monohydricum .......................................1307 inhalation (2.9.18.) .........................................................5.1-2799
Acidum edeticum .................................................................... 1494 Aether .........................................................................................1548
Acidum etacrynicum..............................................................1542 Aether anaestheticus ..............................................................1549
Acidum folicum ....................................................................... 1630 Agar............................................................................................... 928
Acidum fusidicum ................................................................... 1645 Agrimoniae herba ..................................................................... 929
Acidum glutamicum ............................................................... 1670 Agrimony ..................................................................................... 929
Acidum hydrochloridum concentratum............................ 1755 Air, medicinal .............................................................................. 929
Acidum hydrochloridum dilutum ....................................... 1756 Air, synthetic medicinal ............................................................ 932
Acidum iopanoicum............................................................... 1824 Alanine ......................................................................................... 933
Acidum iotalamicum.............................................................. 1825 Alaninum..................................................................................... 933
Acidum ioxaglicum................................................................. 1826 Albendazole................................................................................. 934
Acidum lacticum ..................................................................... 1882 Albendazolum ............................................................................ 934
Acidum lactobionicum........................................................... 1885 Albumini humani solutio...................................................... 1731
Acidum maleicum ................................................................... 1966 Albumin solution, human ..................................................... 1731
Acidum malicum ..................................................................... 1966 Alchemilla .................................................................................... 935
Acidum mefenamicum........................................................... 1984 Alchemillae herba ..................................................................... 935
Acidum methacrylicum et ethylis acrylas polymerisatum Alcohol benzylicus ...........................................................5.1-2886
1:1 .............................................................................................2005 Alcohol cetylicus......................................................................1243
Acidum methacrylicum et ethylis acrylas polymerisatum Alcohol cetylicus et stearylicus ...........................................1239
1:1 dispersio 30 per centum ..............................................2005 Alcohol cetylicus et stearylicus emulsificans A ..............1239
Acidum methacrylicum et methylis methacrylas Alcohol cetylicus et stearylicus emulsificans B .............. 1241
polymerisatum 1:1................................................................2006 Alcoholes adipis lanae ...........................................................2703
Acidum methacrylicum et methylis methacrylas Alcoholimetric tables (2.9.10.) ................................................ 237
polymerisatum 1:2................................................................2007 Alcoholimetric tables (5.5.) .......................................................519
Acidum nalidixicum...............................................................2080 Alcohol isopropylicus............................................................. 1841
Acidum nicotinicum...............................................................2097 Alcohol oleicus......................................................................... 2134
Acidum nitricum ..................................................................... 2105 Alcohol stearylicus..................................................................2492
Acidum oleicum....................................................................... 2132 Alcuronii chloridum................................................................. 935
Acidum oxolinicum ................................................................ 2165 Alcuronium chloride.................................................................. 935
Acidum palmiticum ................................................................ 2179 Alexandrian senna pods .........................................................2404
Acidum phosphoricum concentratum...............................2237 Alfacalcidol .................................................................................. 937
Acidum phosphoricum dilutum ..........................................2238 Alfacalcidolum ........................................................................... 937
Acidum pipemidicum trihydricum.....................................2249 Alfadex.......................................................................................... 938
Acidum salicylicum .........................................................5.1-3007 Alfadexum ................................................................................... 938
Acidum (S)-lacticum ............................................................... 1883 Alfentanil hydrochloride........................................................... 939
Acidum sorbicum ....................................................................2467 Alfentanili hydrochloridum.................................................... 939
Acidum stearicum ...................................................................2490 Alfuzosin hydrochloride ........................................................... 941
Acidum sulfuricum .................................................................2520 Alfuzosini hydrochloridum .................................................... 941
Acidum tartaricum .................................................................2534 Alginic acid .................................................................................. 942
Acidum tiaprofenicum...........................................................2578 Alkaline-earth metals and magnesium (2.4.7.) .................... 104
Acidum tolfenamicum............................................................ 2601 Alkaline impurities in fatty oils (2.4.19.)............................... 109
Acidum tranexamicum ..........................................................2609 Allantoin....................................................................................... 942
Acidum trichloraceticum ......................................................2620 Allantoinum................................................................................ 942
Acidum undecylenicum ........................................................2658 Allergen products....................................................................... 569
Acidum ursodeoxycholicum.................................................2662 Allii sativi bulbi pulvis ........................................................... 1651
Acidum valproicum ................................................................2669 Allium sativum ad praeparationes homoeopathicas ....... 897
Acid value (2.5.1.)....................................................................... 127 Allopurinol................................................................................... 943
Acitretin........................................................................................ 922 Allopurinolum............................................................................ 943
Acitretinum ................................................................................. 922 all-rac-α-Tocopherol..........................................................5.1-3023
Acriflavinii monochloridum .................................................. 924 all-rac-α-Tocopheryl acetate ...........................................5.1-3024
Acriflavinium monochloride.................................................... 924 Almagate ...................................................................................... 945
Actinobacillosis vaccine (inactivated), porcine .................... 784 Almagatum.................................................................................. 945
Activated charcoal....................................................................1246 Almond oil, refined .................................................................... 946
Activated coagulation factors (2.6.22.).................................. 177 Almond oil, virgin ...................................................................... 947
Additives, plastic (3.1.13.)......................................................... 293 Aloe barbadensis ....................................................................... 947
Adenine ........................................................................................ 924 Aloe capensis.............................................................................. 948
Adeninum.................................................................................... 924 Aloes, barbados .......................................................................... 947
Adenosine .................................................................................... 925 Aloes, Cape .................................................................................. 948
Adenosinum ............................................................................... 925 Aloes dry extract, standardised............................................... 949
Adeps lanae ..............................................................................2704 Aloes extractum siccum normatum...................................... 949
Adeps lanae cum aqua...........................................................2709 Alphacyclodextrin ...................................................................... 938
Adeps lanae hydrogenatus ...................................................2708 Alprazolam .................................................................................. 950
Adeps solidus............................................................................ 1711 Alprazolamum ........................................................................... 950
Adipic acid ................................................................................... 926 Alprenolol hydrochloride ......................................................... 952
Adrenaline tartrate .................................................................... 927 Alprenololi hydrochloridum................................................... 952
Adrenalini tartras...................................................................... 927 Alprostadil ................................................................................... 953

3050 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Alprostadilum............................................................................. 953 Amoxicillinum natricum......................................................... 990


Alteplase for injection ............................................................... 956 Amoxicillinum trihydricum.................................................... 992
Alteplasum ad iniectabile........................................................ 956 Amperometric titration (2.2.19.) ............................................... 34
Althaeae folium........................................................................ 1974 Amphotericin B .......................................................................... 995
Althaeae radix .......................................................................... 1975 Amphotericinum B ................................................................... 995
Alum.............................................................................................. 959 Ampicillin, anhydrous .............................................................. 996
Alumen......................................................................................... 959 Ampicillin sodium ...................................................................... 998
Aluminii chloridum hexahydricum ..................................... 960 Ampicillin trihydrate ............................................................... 1001
Aluminii hydroxidum hydricum ad adsorptionem.......... 960 Ampicillinum anhydricum ..................................................... 996
Aluminii magnesii silicas ....................................................... 961 Ampicillinum natricum........................................................... 998
Aluminii oxidum hydricum.................................................... 962 Ampicillinum trihydricum.................................................... 1001
Aluminii phosphas hydricus .................................................. 963 Amygdalae oleum raffinatum ................................................ 946
Aluminii sulfas........................................................................... 964 Amygdalae oleum virginale ................................................... 947
Aluminium (2.4.17.) ................................................................... 108 Amylum pregelificatum .........................................................2490
Aluminium chloride hexahydrate........................................... 960 Anaesthetic ether .....................................................................1549
Aluminium hydroxide, hydrated, for adsorption................. 960 Analysis, thermal (2.2.34.).......................................................... 52
Aluminium in adsorbed vaccines (2.5.13.).............................131 Angelicae radix........................................................................ 1003
Aluminium magnesium silicate............................................... 961 Angelica root............................................................................. 1003
Aluminium oxide, hydrated...................................................... 962 Animal anti-T lymphocyte immunoglobulin for human
Aluminium phosphate, hydrated ............................................ 963 use............................................................................................. 1010
Aluminium sulphate .................................................................. 964 Animal spongiform encephalopathies, products with risk of
Amantadine hydrochloride ...................................................... 964 transmitting agents of............................................................. 577
Amantadini hydrochloridum ................................................. 964 Animal spongiform encephalopathy agents, minimising the
Ambroxol hydrochloride........................................................... 965 risk of transmitting via human and veterinary medicinal
Ambroxoli hydrochloridum .................................................... 965 products (5.2.8.) ....................................................................... 463
Amfetamine sulphate ................................................................ 966 Aniseed ....................................................................................... 1006
Amfetamini sulfas ..................................................................... 966 Anise oil...................................................................................... 1004
Amidotrizoic acid dihydrate..................................................... 967 Anisi aetheroleum................................................................... 1004
Amikacin ...................................................................................... 968 Anisidine value (2.5.36.) ........................................................... 142
Amikacini sulfas ........................................................................ 970 Anisi fructus ............................................................................. 1006
Amikacin sulphate ..................................................................... 970 Anisi stellati aetheroleum .....................................................2488
Amikacinum ............................................................................... 968 Anisi stellati fructus................................................................2487
Amiloride hydrochloride........................................................... 972 Antazoline hydrochloride....................................................... 1006
Amiloridi hydrochloridum...................................................... 972 Antazolini hydrochloridum.................................................. 1006
Amino acid analysis (2.2.56.)..................................................... 86 Anthrax spore vaccine (live) for veterinary use................... 715
Aminocaproic acid ..................................................................... 974 Anti-A and anti-B haemagglutinins (indirect method)
Aminoglutethimide.................................................................... 975 (2.6.20.) .......................................................................................174
Aminoglutethimidum............................................................... 975 Antibiotics, microbiological assay of (2.7.2.) ........................ 188
Amiodarone hydrochloride ...................................................... 977 Anticoagulant and preservative solutions for human blood
Amiodaroni hydrochloridum ................................................. 977 ................................................................................................... 1007
Amisulpride ................................................................................. 978 Anticomplementary activity of immunoglobulin (2.6.17.).. 170
Amisulpridum ............................................................................ 978 Anti-D immunoglobulin, human ........................................... 1732
Amitriptyline hydrochloride .................................................... 980 Anti-D immunoglobulin, human, assay of (2.7.13.)............. 205
Amitriptylini hydrochloridum ............................................... 980 Anti-D immunoglobulin, human, for intravenous
Amlodipine besilate ................................................................... 981 administration ........................................................................ 1733
Amlodipini besilas .................................................................... 981 Antimicrobial preservation, efficacy of (5.1.3.) .................... 447
Ammonia (13N) injection ............................................................817 Antiserum, European viper venom ........................................ 806
Ammoniae (13N) solutio iniectabilis ......................................817 Antithrombin III concentrate, human ................................. 1733
Ammoniae solutio concentrata ............................................. 983 Antithrombin III, human, assay of (2.7.17.) .......................... 209
Ammonia solution, concentrated ........................................... 983 Antithrombinum III humanum densatum ....................... 1733
Ammonii bromidum ................................................................. 985 Anti-T lymphocyte immunoglobulin for human use,
Ammonii chloridum ................................................................. 986 animal....................................................................................... 1010
Ammonii glycyrrhizas ....................................................5.1-2876 Apis mellifera ad praeparationes homoeopathicas.......... 898
Ammonii hydrogenocarbonas ............................................... 988 Apomorphine hydrochloride ..................................................1014
Ammonio methacrylate copolymer (type A) ........................ 983 Apomorphini hydrochloridum .............................................1014
Ammonio methacrylate copolymer (type B) ........................ 984 Apparatus (2.1.) .............................................................................17
Ammonio methacrylatis copolymerum A........................... 983 Apparent volume (2.9.15.)........................................................ 241
Ammonio methacrylatis copolymerum B .......................... 984 Application of the F0 concept to steam sterilisation of
Ammonium (2.4.1.) .................................................................... 103 aqueous preparations (5.1.5.).......................................5.1-2821
Ammonium bromide.................................................................. 985 Aprotinin .................................................................................... 1015
Ammonium chloride.................................................................. 986 Aprotinin concentrated solution........................................... 1016
Ammonium glycyrrhizate................................................5.1-2876 Aprotinini solutio concentrata ............................................ 1016
Ammonium hydrogen carbonate ............................................ 988 Aprotininum ............................................................................. 1015
Amobarbital................................................................................. 988 Aqua ad dilutionem solutionium concentratarum ad
Amobarbital sodium .................................................................. 989 haemodialysim ...................................................................... 1699
Amobarbitalum .......................................................................... 988 Aqua ad iniectabilia ...............................................................2692
Amobarbitalum natricum ....................................................... 989 Aquae (15O) solutio iniectabilis.............................................. 868
Amoxicillin sodium .................................................................... 990 Aquae tritiatae (3H) solutio iniectabilis............................... 867
Amoxicillin trihydrate ............................................................... 992 Aqua purificata........................................................................2697

General Notices (1) apply to all monographs and other texts 3051
Index EUROPEAN PHARMACOPOEIA 5.1

Aqua valde purificata.............................................................2695 Auricularia.................................................................................. 601


Arachidis oleum hydrogenatum.......................................... 1018 Avian infectious bronchitis vaccine (inactivated)................ 718
Arachidis oleum raffinatum ................................................. 1018 Avian infectious bronchitis vaccine (live) ............................. 720
Arachis oil, hydrogenated ...................................................... 1018 Avian infectious bursal disease vaccine (inactivated) ....... 722
Arachis oil, refined................................................................... 1018 Avian infectious bursal disease vaccine (live) ...................... 723
Argenti nitras ........................................................................... 2412 Avian infectious encephalomyelitis vaccine (live) ............... 725
Arginine...................................................................................... 1019 Avian infectious laryngotracheitis vaccine (live)................. 727
Arginine aspartate ................................................................... 1020 Avian live virus vaccines : tests for extraneous agents in
Arginine hydrochloride........................................................... 1021 batches of finished product (2.6.25.)................................... 180
Arginini aspartas .................................................................... 1020 Avian paramyxovirus 3 vaccine (inactivated)....................... 728
Arginini hydrochloridum...................................................... 1021 Avian viral tenosynovitis vaccine (live).................................. 729
Argininum................................................................................. 1019 Avian viral vaccines : tests for extraneous agents in seed lots
Arnicae flos............................................................................... 1022 (2.6.24.) ...................................................................................... 177
Arnicae tinctura ...............................................................5.1-2877 Azaperone for veterinary use ................................................ 1036
Arnica flower............................................................................. 1022 Azaperonum ad usum veterinarium.................................. 1036
Arnica tincture...................................................................5.1-2877 Azathioprine.............................................................................. 1037
Arsenic (2.4.2.)............................................................................ 103 Azathioprinum......................................................................... 1037
Arsenii trioxidum ad praeparationes homoeopathicas .. 895 Azelastine hydrochloride........................................................ 1037
Arsenious trioxide for homoeopathic preparations............ 895 Azelastini hydrochloridum................................................... 1037
Articaine hydrochloride.......................................................... 1023 Azithromycin............................................................................. 1039
Articaini hydrochloridum..................................................... 1023 Azithromycinum...................................................................... 1039
Ascorbic acid ............................................................................. 1025
Ascorbylis palmitas................................................................. 1026 B
Ascorbyl palmitate ................................................................... 1026 Bacampicillin hydrochloride.................................................. 1043
Ash insoluble in hydrochloric acid (2.8.1.)........................... 215 Bacampicillini hydrochloridum.......................................... 1043
Ash leaf....................................................................................... 1026 Bacitracin................................................................................... 1045
Asparagine monohydrate ....................................................... 1027 Bacitracinum............................................................................ 1045
Asparaginum monohydricum.............................................. 1027 Bacitracinum zincum ............................................................ 1047
Aspartame.................................................................................. 1028 Bacitracin zinc .......................................................................... 1047
Aspartamum ............................................................................. 1028 Baclofen ..................................................................................... 1050
Aspartic acid.............................................................................. 1029 Baclofenum............................................................................... 1050
Assay of 1,8-cineole in essential oils (2.8.11.) .......................216 Bacterial endotoxins (2.6.14.)...................................................161
Assay of diphtheria vaccine (adsorbed) (2.7.6.) ................... 196 Ballotae nigrae herba ............................................................ 1113
Assay of heparin (2.7.5.) ........................................................... 195 Balsamum peruvianum......................................................... 2215
Assay of heparin in coagulation factors (2.7.12.)................ 204 Balsamum tolutanum ............................................................2603
Assay of hepatitis A vaccine (2.7.14.) ............................5.1-2795 Bambuterol hydrochloride..................................................... 1051
Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 207 Bambuteroli hydrochloridum .............................................. 1051
Assay of human anti-D immunoglobulin (2.7.13.)............... 205 Barbados aloes ........................................................................... 947
Assay of human antithrombin III (2.7.17.) ............................ 209 Barbital....................................................................................... 1052
Assay of human coagulation factor II (2.7.18.).................... 209 Barbitalum ................................................................................ 1052
Assay of human coagulation factor IX (2.7.11.)................... 204 Barii sulfas................................................................................ 1053
Assay of human coagulation factor VII (2.7.10.) ................. 203 Barium sulphate....................................................................... 1053
Assay of human coagulation factor VIII (2.7.4.).................. 194 Basic butylated methacrylate copolymer............................ 1053
Assay of human coagulation factor X (2.7.19.) .....................210 BCG ad immunocurationem .................................................. 635
Assay of human coagulation factor XI (2.7.22.) .................. 212 BCG for immunotherapy .......................................................... 635
Assay of human von Willebrand factor (2.7.21.) ..................211 BCG vaccine, freeze-dried ........................................................ 636
Assay of interferons (5.6.)......................................................... 533 Bearberry leaf ........................................................................... 1054
Assay of pertussis vaccine (2.7.7.)........................................... 197 Beclometasone dipropionate, anhydrous ....................5.1-2881
Assay of pertussis vaccine (acellular) (2.7.16.) .................... 208 Beclometasone dipropionate monohydrate ................5.1-2883
Assay of tetanus vaccine (adsorbed) (2.7.8.) ...............5.1-2791 Beclometasoni dipropionas anhydricus ....................5.1-2881
Assays (2.5.)................................................................................. 127 Beclometasoni dipropionas monohydricus ..............5.1-2883
Astemizole ................................................................................. 1030 Bee for homoeopathic preparations, honey......................... 898
Astemizolum............................................................................. 1030 Beeswax, white ......................................................................... 1057
Atenolol...................................................................................... 1032 Beeswax, yellow........................................................................ 1058
Atenololum................................................................................ 1032 Belladonnae folii extractum siccum normatum ............. 1060
Atomic absorption spectrometry (2.2.23.) .............................. 36 Belladonnae folii tinctura normata ................................... 1061
Atomic emission spectrometry (2.2.22.).................................. 35 Belladonnae folium ................................................................ 1058
Atropine ..................................................................................... 1033 Belladonnae pulvis normatus.............................................. 1062
Atropine sulphate..................................................................... 1035 Belladonna leaf......................................................................... 1058
Atropini sulfas.......................................................................... 1035 Belladonna leaf dry extract, standardised .......................... 1060
Atropinum................................................................................. 1033 Belladonna leaf tincture, standardised................................ 1061
Aujeszky’s disease vaccine (inactivated) for pigs................ 715 Belladonna, prepared .............................................................. 1062
Aujeszky’s disease vaccine (live) for pigs for parenteral Bendroflumethiazide .......................................................5.1-2885
administration, freeze-dried....................................................717 Bendroflumethiazidum ..................................................5.1-2885
Aurantii amari epicarpii et mesocarpii tinctura ............ 1110 Benfluorex hydrochloride ...................................................... 1064
Aurantii amari epicarpium et mesocarpium................... 1110 Benfluorexi hydrochloridum ............................................... 1064
Aurantii amari floris aetheroleum ..................................... 1112 Benperidol ................................................................................. 1065
Aurantii amari flos ..................................................................1111 Benperidolum .......................................................................... 1065
Aurantii dulcis aetheroleum.................................................2526 Benserazide hydrochloride .................................................... 1067

3052 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Benserazidi hydrochloridum ............................................... 1067 Bismuthi subcarbonas ........................................................... 1105


Bentonite ................................................................................... 1068 Bismuthi subgallas ................................................................. 1106
Bentonitum............................................................................... 1068 Bismuthi subnitras ponderosum......................................... 1107
Benzalkonii chloridi solutio ................................................ 1069 Bismuthi subsalicylas ............................................................ 1107
Benzalkonii chloridum.......................................................... 1068 Bismuth subcarbonate............................................................ 1105
Benzalkonium chloride........................................................... 1068 Bismuth subgallate.................................................................. 1106
Benzalkonium chloride solution .......................................... 1069 Bismuth subnitrate, heavy ..................................................... 1107
Benzathine benzylpenicillin .................................................. 1077 Bismuth subsalicylate ............................................................. 1107
Benzbromarone........................................................................ 1070 Bitter fennel ..............................................................................1580
Benzbromaronum................................................................... 1070 Bitter-fennel fruit oil................................................................ 1108
Benzethonii chloridum ......................................................... 1071 Bitterness value (2.8.15.).......................................................... 221
Benzethonium chloride .......................................................... 1071 Bitter-orange epicarp and mesocarp.................................... 1110
Benzocaine ................................................................................ 1072 Bitter-orange-epicarp and mesocarp tincture .................... 1110
Benzocainum ........................................................................... 1072 Bitter-orange flower .................................................................1111
Benzoic acid .............................................................................. 1072 Bitter-orange-flower oil........................................................... 1112
Benzoylis peroxidum cum aqua ......................................... 1073 Black horehound ..................................................................... 1113
Benzoyl peroxide, hydrous .................................................... 1073 Bleomycini sulfas.....................................................................1114
Benzyl alcohol ...................................................................5.1-2886 Bleomycin sulphate ..................................................................1114
Benzyl benzoate ....................................................................... 1076 Blood and blood components, empty sterile containers of
Benzylis benzoas..................................................................... 1076 plasticised poly(vinyl chloride) for (3.2.4.) ..........................311
Benzylpenicillin, benzathine ................................................. 1077 Blood and blood components, materials for containers for
Benzylpenicillin potassium.................................................... 1078 (3.1.1.)......................................................................................... 269
Benzylpenicillin, procaine...................................................... 1080 Blood and blood components, sets for the transfusion of
Benzylpenicillin sodium ......................................................... 1082 (3.2.6.) .........................................................................................313
Benzylpenicillinum benzathinum...................................... 1077 Blood and blood components, sterile plastic containers for
Benzylpenicillinum kalicum................................................ 1078 (3.2.3.) ........................................................................................ 309
Benzylpenicillinum natricum ............................................. 1082 Blood, anticoagulant and preservative solutions for ....... 1007
Benzylpenicillinum procainum.......................................... 1080 Blood, sterile containers of plasticised poly (vinyl chloride)
Betacarotene ............................................................................. 1083 containing anticoagulant solution (3.2.5.) ......................... 312
Betacarotenum ........................................................................ 1083 Bogbean leaf ............................................................................. 1115
Betacyclodextrin ...................................................................... 1084 Boiling point (2.2.12.) ..................................................................31
Betadex ...................................................................................... 1084 Boldi folium.......................................................................5.1-2888
Betadexum ................................................................................ 1084 Boldo leaf............................................................................5.1-2888
Betahistine dihydrochloride ...........................................5.1-2887 Borage (starflower) oil, refined......................................5.1-2889
Betahistine mesilate ................................................................ 1086 Borago officinalis oleum raffinatum ..........................5.1-2889
Betahistini dihydrochloridum ......................................5.1-2887 Borax .......................................................................................... 1116
Betahistini mesilas ................................................................. 1086 Boric acid....................................................................................1117
Betamethasone......................................................................... 1087 Botulinum antitoxin .................................................................. 801
Betamethasone acetate .......................................................... 1089 Botulinum toxin type A for injection....................................1117
Betamethasone dipropionate ................................................ 1090 Bovine infectious rhinotracheitis vaccine (live),
Betamethasone sodium phosphate...................................... 1092 freeze-dried................................................................................ 768
Betamethasone valerate ......................................................... 1094 Bovine insulin ........................................................................... 1797
Betamethasoni acetas ............................................................ 1089 Bovine leptospirosis vaccine (inactivated)............................ 730
Betamethasoni dipropionas ................................................. 1090 Bovine parainfluenza virus vaccine (live), freeze-dried ..... 732
Betamethasoni natrii phosphas .......................................... 1092 Bovine respiratory syncytial virus vaccine (live),
Betamethasoni valeras........................................................... 1094 freeze-dried................................................................................ 733
Betamethasonum .................................................................... 1087 Bovine viral diarrhoea vaccine (inactivated)........................ 734
Betaxolol hydrochloride ......................................................... 1095 Bromazepam ............................................................................. 1119
Betaxololi hydrochloridum................................................... 1095 Bromazepamum...................................................................... 1119
Betulae folium.......................................................................... 1103 Bromhexine hydrochloride .................................................... 1120
Bezafibrate ................................................................................ 1096 Bromhexini hydrochloridum ............................................... 1120
Bezafibratum............................................................................ 1096 Bromocriptine mesilate .......................................................... 1121
Bifonazole.................................................................................. 1098 Bromocriptini mesilas ........................................................... 1121
Bifonazolum............................................................................. 1098 Bromperidol .............................................................................. 1124
Bilberry fruit, dried ................................................................. 1099 Bromperidol decanoate .......................................................... 1125
Bilberry fruit, fresh.................................................................. 1099 Bromperidoli decanoas ......................................................... 1125
Biological assays (2.7.) .............................................................. 187 Bromperidolum ....................................................................... 1124
Biological assays and tests, statistical analysis of (5.3.) .... 475 Brompheniramine maleate..................................................... 1127
Biological indicators of sterilisation (5.1.2.) ........................ 447 Brompheniramini maleas .................................................... 1127
Biological tests (2.6.)................................................................. 145 Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain),
Biotin .......................................................................................... 1100 freeze-dried, for veterinary use ...................................5.1-2859
Biotinum ................................................................................... 1100 Buccal tablets and sublingual tablets.................................... 613
Biperiden hydrochloride..........................................................1101 Budesonide................................................................................ 1128
Biperideni hydrochloridum ..................................................1101 Budesonidum ........................................................................... 1128
Biphasic insulin injection....................................................... 1802 Bufexamac ................................................................................. 1130
Biphasic isophane insulin injection ..................................... 1803 Bufexamacum .......................................................................... 1130
Birch leaf.................................................................................... 1103 Buffer solutions (4.1.3.) ............................................................ 430
Bisacodyl.................................................................................... 1104 Buflomedil hydrochloride ...................................................... 1131
Bisacodylum............................................................................. 1104 Buflomedili hydrochloridum ............................................... 1131

General Notices (1) apply to all monographs and other texts 3053
Index EUROPEAN PHARMACOPOEIA 5.1

Bumetanide ............................................................................... 1132 Calcium in adsorbed vaccines (2.5.14.) ..................................131


Bumetanidum .......................................................................... 1132 Calcium lactate, anhydrous ............................................5.1-2894
Bupivacaine hydrochloride .................................................... 1133 Calcium lactate monohydrate ........................................5.1-2895
Bupivacaini hydrochloridum............................................... 1133 Calcium lactate pentahydrate ........................................5.1-2896
Buprenorphine ......................................................................... 1135 Calcium lactate trihydrate...............................................5.1-2897
Buprenorphine hydrochloride .............................................. 1136 Calcium levofolinate pentahydrate ...................................... 1163
Buprenorphini hydrochloridum ......................................... 1136 Calcium levulinate dihydrate................................................. 1165
Buprenorphinum ................................................................... 1135 Calcium pantothenate............................................................. 1166
Buserelin.................................................................................... 1137 Calcium phosphate .................................................................. 1167
Buserelinum ............................................................................. 1137 Calcium stearate....................................................................... 1167
Busulfan..................................................................................... 1138 Calcium sulphate dihydrate................................................... 1169
Busulfanum .............................................................................. 1138 Calendulae flos ........................................................................ 1169
Butcher’s broom....................................................................... 1138 Calendula flower ...................................................................... 1169
Butylhydroxyanisole.................................................................1141 Calf coronavirus diarrhoea vaccine (inactivated)................ 736
Butylhydroxyanisolum ...........................................................1141 Calf rotavirus diarrhoea vaccine (inactivated)..................... 737
Butylhydroxytoluene................................................................1141 Calicivirosis vaccine (inactivated), feline............................... 757
Butylhydroxytoluenum...........................................................1141 Calicivirosis vaccine (live), feline, freeze-dried..................... 758
Butylis parahydroxybenzoas................................................ 1140 Camphora racemica ............................................................... 1172
Butyl parahydroxybenzoate................................................... 1140 Camphor, D- ............................................................................... 1170
Camphor, racemic .................................................................... 1172
C Canine adenovirus vaccine (inactivated) .............................. 738
Cachets ......................................................................................... 601 Canine adenovirus vaccine (live) ............................................ 738
Caffeine ...................................................................................... 1145 Canine distemper vaccine (live), freeze-dried....................... 740
Caffeine monohydrate............................................................. 1146 Canine leptospirosis vaccine (inactivated)............................ 740
Calcifediol .................................................................................. 1147 Canine parainfluenza virus vaccine (live)............................. 742
Calcifediolum ........................................................................... 1147 Canine parvovirosis vaccine (inactivated)............................. 743
Calcii acetas ......................................................................5.1-2893 Canine parvovirosis vaccine (live) .......................................... 744
Calcii ascorbas......................................................................... 1150 Cape aloes.................................................................................... 948
Calcii carbonas .................................................................5.1-2894 Capillary electrophoresis (2.2.47.).............................................74
Calcii chloridum dihydricum .............................................. 1152 Capillary viscometer method (2.2.9.)....................................... 29
Calcii chloridum hexahydricum ......................................... 1153 Caprylic acid.............................................................................. 1172
Calcii dobesilas monohydricum.......................................... 1153 Caprylocaproyl macrogolglycerides..................................... 1173
Calcii folinas ............................................................................ 1154 Capsici fructus ..........................................................................1174
Calcii glucoheptonas.............................................................. 1156 Capsicum.....................................................................................1174
Calcii gluconas ........................................................................ 1157 Capsulae ...................................................................................... 599
Calcii gluconas ad iniectabile ............................................. 1158 Capsules ....................................................................................... 599
Calcii glycerophosphas.......................................................... 1159 Capsules and tablets, disintegration of (2.9.1.) ................... 225
Calcii hydrogenophosphas anhydricus............................. 1160 Capsules, gastro-resistant......................................................... 600
Calcii hydrogenophosphas dihydricus.............................. 1160 Capsules, hard ............................................................................ 600
Calcii hydroxidum .................................................................. 1161 Capsules, modified-release ....................................................... 600
Calcii lactas anhydricus.................................................5.1-2894 Capsules, oromucosal ............................................................... 613
Calcii lactas monohydricus...........................................5.1-2895 Capsules, rectal........................................................................... 623
Calcii lactas pentahydricus ...........................................5.1-2896 Capsules, soft .............................................................................. 600
Calcii lactas trihydricus .................................................5.1-2897 Capsules, vaginal........................................................................ 629
Calcii laevulinas dihydricum............................................... 1165 Captopril .....................................................................................1176
Calcii levofolinas pentahydricus ........................................ 1163 Captoprilum ..............................................................................1176
Calcii pantothenas.................................................................. 1166 Caraway fruit............................................................................. 1177
Calcii stearas ............................................................................ 1167 Carbachol................................................................................... 1177
Calcii sulfas dihydricus ......................................................... 1169 Carbacholum............................................................................ 1177
Calcitonin (salmon).................................................................. 1148 Carbamazepine ......................................................................... 1178
Calcitoninum salmonis ......................................................... 1148 Carbamazepinum ................................................................... 1178
Calcitriol..................................................................................... 1149 Carbasalate calcium................................................................. 1179
Calcitriolum.............................................................................. 1149 Carbasalatum calcicum......................................................... 1179
Calcium (2.4.3.)........................................................................... 103 Carbidopa .................................................................................. 1180
Calcium acetate .................................................................5.1-2893 Carbidopum.............................................................................. 1180
Calcium ascorbate.................................................................... 1150 Carbimazole .............................................................................. 1182
Calcium carbonate ............................................................5.1-2894 Carbimazolum ......................................................................... 1182
Calcium carboxymethylcellulose .......................................... 1188 Carbo activatus ........................................................................1246
Calcium chloride dihydrate.................................................... 1152 Carbocisteine ............................................................................ 1182
Calcium chloride hexahydrate .............................................. 1153 Carbocisteinum ....................................................................... 1182
Calcium dobesilate monohydrate ......................................... 1153 Carbomera ................................................................................ 1183
Calcium folinate ....................................................................... 1154 Carbomers ................................................................................. 1183
Calcium glucoheptonate......................................................... 1156 Carbon dioxide ......................................................................... 1185
Calcium gluconate ................................................................... 1157 Carbon dioxide in gases (2.5.24.) ........................................... 134
Calcium gluconate for injection............................................ 1158 Carbonei dioxidum................................................................. 1185
Calcium glycerophosphate..................................................... 1159 Carbonei monoxidum (15O) .....................................................818
Calcium hydrogen phosphate, anhydrous .......................... 1160 Carbon monoxide (15O) ..............................................................818
Calcium hydrogen phosphate dihydrate ............................. 1160 Carbon monoxide in gases (2.5.25.)....................................... 134
Calcium hydroxide ................................................................... 1161 Carboplatin................................................................................ 1186

3054 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Carboplatinum......................................................................... 1186 Cefuroximum natricum.........................................................1223


Carboxymethylamylum natricum A...................................2450 Celiprolol hydrochloride.........................................................1224
Carboxymethylamylum natricum B................................... 2451 Celiprololi hydrochloridum..................................................1224
Carboxymethylamylum natricum C................................... 2451 Cell cultures for the production of veterinary vaccines
Carboxymethylcellulose calcium .......................................... 1188 (5.2.4.) ........................................................................................ 458
Carboxymethylcellulose sodium........................................... 1189 Cell substrates for the production of vaccines for human use
Carboxymethylcellulose sodium, cross-linked ................... 1371 (5.2.3.) ........................................................................................ 455
Carboxymethylcellulose sodium, low-substituted............. 1190 Cellulose acetate ......................................................................1226
Carisoprodol.............................................................................. 1187 Cellulose acetate butyrate......................................................1227
Carisoprodolum....................................................................... 1187 Cellulose acetate phthalate....................................................1227
Carmellose calcium.................................................................. 1188 Cellulose, microcrystalline.....................................................1228
Carmellose sodium .................................................................. 1189 Cellulose, powdered ................................................................1232
Carmellose sodium, low-substituted .................................... 1190 Cellulosi acetas ........................................................................1226
Carmellosum calcicum .......................................................... 1188 Cellulosi acetas butyras.........................................................1227
Carmellosum natricum ......................................................... 1189 Cellulosi acetas phthalas.......................................................1227
Carmellosum natricum conexum ....................................... 1371 Cellulosi pulvis ........................................................................1232
Carmellosum natricum, substitutum humile................... 1190 Cellulosum microcristallinum .............................................1228
Carmustine ................................................................................ 1191 Centaurii herba .......................................................................1235
Carmustinum ........................................................................... 1191 Centaury ....................................................................................1235
Carnauba wax ........................................................................... 1191 Centella ......................................................................................1236
Carteolol hydrochloride.......................................................... 1192 Centellae asiaticae herba......................................................1236
Carteololi hydrochloridum ................................................... 1192 Cera alba ................................................................................... 1057
Carthami oleum raffinatum .................................................2389 Cera carnauba ......................................................................... 1191
Carvedilol................................................................................... 1193 Cera flava .................................................................................. 1058
Carvedilolum............................................................................ 1193 Cetirizine dihydrochloride .....................................................1237
Carvi fructus............................................................................. 1177 Cetirizini dihydrochloridum................................................1237
Caryophylli floris aetheroleum ...........................................1335 Cetobemidoni hydrochloridum ........................................... 1871
Caryophylli flos .......................................................................1334 Cetostearyl alcohol ..................................................................1239
Cascara ....................................................................................... 1194 Cetostearyl alcohol (type A), emulsifying ...........................1239
Cassia oil .................................................................................... 1196 Cetostearyl alcohol (type B), emulsifying........................... 1241
Castor oil, hydrogenated ........................................................ 1197 Cetostearylis isononanoas....................................................1242
Castor oil, polyoxyl .................................................................. 1949 Cetostearyl isononanoate.......................................................1242
Castor oil, polyoxyl hydrogenated........................................ 1948 Cetrimide ...................................................................................1243
Castor oil, virgin....................................................................... 1197 Cetrimidum...............................................................................1243
Catgut, sterile.............................................................................. 873 Cetyl alcohol .............................................................................1243
Catgut, sterile, in distributor for veterinary use ................. 885 Cetylis palmitas .......................................................................1244
Cefaclor ...................................................................................... 1198 Cetyl palmitate..........................................................................1244
Cefaclorum ............................................................................... 1198 Cetylpyridinii chloridum ......................................................1244
Cefadroxil monohydrate .........................................................1200 Cetylpyridinium chloride........................................................1244
Cefadroxilum monohydricum .............................................1200 Ceylon cinnamon bark oil ......................................................1295
Cefalexin monohydrate...........................................................1202 Ceylon cinnamon leaf oil........................................................1296
Cefalexinum monohydricum ...............................................1202 Chamomile flower, Roman.....................................................1245
Cefalotin sodium ......................................................................1203 Chamomillae romanae flos ..................................................1245
Cefalotinum natricum ...........................................................1203 Characters section in monographs (5.11.)............................ 565
Cefamandole nafate.................................................................1204 Charcoal, activated ..................................................................1246
Cefamandoli nafas..................................................................1204 Chelidonii herba...................................................................... 1690
Cefapirin sodium......................................................................1206 Chenodeoxycholic acid ..........................................................1247
Cefapirinum natricum...........................................................1206 Chewing gum, medicated, drug release from (2.9.25.) ...... 260
Cefatrizine propylene glycol..................................................1207 Chewing gums, medicated ....................................................... 601
Cefatrizinum propylen glycolum........................................1207 Chicken flocks free from specified pathogens for
Cefazolin sodium......................................................................1209 the production and quality control of vaccines
Cefazolinum natricum...........................................................1209 (5.2.2.) ...............................................................................5.1-2825
Cefixime ..................................................................................... 1211 Chicken infectious anaemia vaccine (live)............................ 769
Cefiximum................................................................................. 1211 Chinidini sulfas .......................................................................2347
Cefoperazone sodium ............................................................. 1212 Chinini hydrochloridum .......................................................2348
Cefoperazonum natricum..................................................... 1212 Chinini sulfas...........................................................................2350
Cefotaxime sodium .................................................................. 1214 Chitosan hydrochloride ..........................................................1248
Cefotaximum natricum ......................................................... 1214 Chitosani hydrochloridum ...................................................1248
Cefoxitin sodium ...................................................................... 1216 Chloral hydrate.........................................................................1249
Cefoxitinum natricum ........................................................... 1216 Chlorali hydras ........................................................................1249
Cefradine.................................................................................... 1217 Chlorambucil.............................................................................1250
Cefradinum............................................................................... 1217 Chlorambucilum......................................................................1250
Ceftazidime................................................................................ 1218 Chloramine ................................................................................2605
Ceftazidimum........................................................................... 1218 Chloramphenicol......................................................................1250
Ceftriaxone sodium..................................................................1220 Chloramphenicoli natrii succinas ......................................1252
Ceftriaxonum natricum.........................................................1220 Chloramphenicoli palmitas.................................................. 1251
Cefuroxime axetil .....................................................................1222 Chloramphenicol palmitate ................................................... 1251
Cefuroxime sodium..................................................................1223 Chloramphenicol sodium succinate.....................................1252
Cefuroximum axetili...............................................................1222 Chloramphenicolum...............................................................1250

General Notices (1) apply to all monographs and other texts 3055
Index EUROPEAN PHARMACOPOEIA 5.1

Chlorcyclizine hydrochloride ................................................1253 Cilastatinum natricum ..........................................................1286


Chlorcyclizini hydrochloridum...........................................1253 Cilazapril....................................................................................1288
Chlordiazepoxide .....................................................................1254 Cilazaprilum ............................................................................1288
Chlordiazepoxide hydrochloride ..........................................1255 Cimetidine..................................................................................1289
Chlordiazepoxidi hydrochloridum .....................................1255 Cimetidine hydrochloride.......................................................1290
Chlordiazepoxidum ................................................................1254 Cimetidini hydrochloridum .................................................1290
Chlorhexidine diacetate..........................................................1256 Cimetidinum ............................................................................1289
Chlorhexidine digluconate solution ....................................1258 Cinchocaine hydrochloride.................................................... 1291
Chlorhexidine dihydrochloride .............................................1259 Cinchocaini hydrochloridum .............................................. 1291
Chlorhexidini diacetas...........................................................1256 Cinchona bark ..........................................................................1292
Chlorhexidini digluconatis solutio.....................................1258 Cinchonae cortex ....................................................................1292
Chlorhexidini dihydrochloridum........................................1259 Cineole........................................................................................1294
Chlorides (2.4.4.) ........................................................................ 104 Cineole in essential oils, assay of, 1,8- (2.8.11.)....................216
Chlorobutanol, anhydrous ..................................................... 1261 Cineolum...................................................................................1294
Chlorobutanol hemihydrate .................................................. 1261 Cinnamomi cassiae aetheroleum ....................................... 1196
Chlorobutanolum anhydricum............................................ 1261 Cinnamomi cortex ..................................................................1295
Chlorobutanolum hemihydricum ....................................... 1261 Cinnamomi corticis tinctura................................................1297
Chlorocresol ..............................................................................1262 Cinnamomi zeylanici folii aetheroleum...........................1296
Chlorocresolum .......................................................................1262 Cinnamomi zeylanicii corticis aetheroleum ...................1295
Chloroquine phosphate ..........................................................1262 Cinnamon ..................................................................................1295
Chloroquine sulphate..............................................................1263 Cinnamon bark oil, Ceylon ....................................................1295
Chloroquini phosphas ...........................................................1262 Cinnamon leaf oil, Ceylon ......................................................1296
Chloroquini sulfas...................................................................1263 Cinnamon tincture...................................................................1297
Chlorothiazide ..........................................................................1264 Cinnarizine ................................................................................1297
Chlorothiazidum .....................................................................1264 Cinnarizinum ..........................................................................1297
Chlorphenamine maleate ................................................5.1-2899 Ciprofibrate ...............................................................................1299
Chlorphenamini maleas.................................................5.1-2899 Ciprofibratum...........................................................................1299
Chlorpromazine hydrochloride.............................................1266 Ciprofloxacin.............................................................................1300
Chlorpromazini hydrochloridum .......................................1266 Ciprofloxacin hydrochloride..................................................1302
Chlorpropamide........................................................................1266 Ciprofloxacini hydrochloridum ..........................................1302
Chlorpropamidum ..................................................................1266 Ciprofloxacinum .....................................................................1300
Chlorprothixene hydrochloride ............................................1267 Circular dichroism (2.2.41.) ....................................................... 63
Chlorprothixeni hydrochloridum .......................................1267 Cisapride monohydrate...........................................................1303
Chlortalidone ............................................................................1269 Cisapride tartrate .....................................................................1304
Chlortalidonum .......................................................................1269 Cisapridi tartras ......................................................................1304
Chlortetracycline hydrochloride...........................................1270 Cisapridum monohydricum.................................................1303
Chlortetracyclini hydrochloridum......................................1270 Cisplatin .....................................................................................1306
Cholecalciferol ..........................................................................1272 Cisplatinum ..............................................................................1306
Cholecalciferol concentrate (oily form)...............................1273 Citric acid, anhydrous .............................................................1306
Cholecalciferol concentrate (powder form)........................1275 Citric acid monohydrate .........................................................1307
Cholecalciferol concentrate (water-dispersible form).......1277 Citronellae aetheroleum........................................................1308
Cholecalciferoli pulvis ...........................................................1275 Citronella oil..............................................................................1308
Cholecalciferolum ...................................................................1272 Clarithromycin...................................................................5.1-2900
Cholecalciferolum densatum oleosum ..............................1273 Clarithromycinum ...........................................................5.1-2900
Cholecalciferolum in aqua dispergibile ............................1277 Clarity and degree of opalescence of liquids (2.2.1.)............ 23
Cholera vaccine .......................................................................... 637 Clary sage oil............................................................................. 1311
Cholera vaccine, freeze-dried .................................................. 638 Clazuril for veterinary use ..................................................... 1312
Cholesterol ................................................................................1279 Clazurilum ad usum veterinarium..................................... 1312
Cholesterolum ..........................................................................1279 Clebopride malate.................................................................... 1314
Chorda resorbilis sterilis ......................................................... 873 Clebopridi malas ..................................................................... 1314
Chorda resorbilis sterilis in fuso ad usum veterinarium.. 885 Clemastine fumarate ............................................................... 1315
Chromatographic separation techniques (2.2.46.) ............... 69 Clemastini fumaras ................................................................ 1315
Chromatography, gas (2.2.28.).................................................. 42 Clenbuterol hydrochloride..............................................5.1-2902
Chromatography, liquid (2.2.29.) ............................................. 43 Clenbuteroli hydrochloridum .......................................5.1-2902
Chromatography, paper (2.2.26.).............................................. 40 Clindamycin hydrochloride.................................................... 1318
Chromatography, size-exclusion (2.2.30.)............................... 45 Clindamycini hydrochloridum............................................ 1318
Chromatography, supercritical fluid (2.2.45.) ....................... 68 Clindamycini phosphas......................................................... 1319
Chromatography, thin-layer (2.2.27.) ....................................... 40 Clindamycin phosphate .......................................................... 1319
Chromii (51Cr) edetatis solutio iniectabilis..........................819 Clioquinol .................................................................................. 1321
Chromium (51Cr) edetate injection ..........................................819 Clioquinolum ........................................................................... 1321
Chymotrypsin............................................................................1280 Clobazam ...................................................................................1322
Chymotrypsinum ....................................................................1280 Clobazamum ............................................................................1322
Ciclopirox...................................................................................1282 Clobetasone butyrate ..............................................................1323
Ciclopirox olamine ...................................................................1283 Clobetasoni butyras ................................................................1323
Ciclopirox olaminum .............................................................1283 Clofazimine................................................................................1324
Ciclopiroxum............................................................................1282 Clofaziminum ..........................................................................1324
Ciclosporin ................................................................................1285 Clofibrate ...................................................................................1325
Ciclosporinum .........................................................................1285 Clofibratum...............................................................................1325
Cilastatin sodium .....................................................................1286 Clomifene citrate ......................................................................1326

3056 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Clomifeni citras .......................................................................1326 Cod-liver oil (type B)................................................................1352


Clomipramine hydrochloride.................................................1328 Coffeinum.................................................................................. 1145
Clomipramini hydrochloridum ...........................................1328 Coffeinum monohydricum ................................................... 1146
Clonazepam...............................................................................1330 Cola .............................................................................................1356
Clonazepamum .......................................................................1330 Colae semen .............................................................................1356
Clonidine hydrochloride......................................................... 1331 Colchicine ..................................................................................1357
Clonidini hydrochloridum.................................................... 1331 Colchicinum .............................................................................1357
Closantel sodium dihydrate for veterinary use ..........5.1-2903 Colestyramine ...........................................................................1359
Closantelum natricum dihydricum Colestyraminum ......................................................................1359
ad usum veterinarium..................................................5.1-2903 Colibacillosis vaccine (inactivated), neonatal piglet........... 776
Clostridium botulinum vaccine for veterinary use ............. 745 Colibacillosis vaccine (inactivated), neonatal ruminant .... 778
Clostridium chauvoei vaccine for veterinary use................ 745 Colistimethate sodium ............................................................1360
Clostridium novyi alpha antitoxin for veterinary use ........5.1- Colistimethatum natricum ...................................................1360
2865 Colistini sulfas ......................................................................... 1361
Clostridium novyi (type B) vaccine for veterinary use....... 746 Colistin sulphate ...................................................................... 1361
Clostridium perfringens beta antitoxin for veterinary use Colloidal anhydrous silica ...................................................... 2410
............................................................................................5.1-2866 Colloidal hydrated silica ......................................................... 2411
Clostridium perfringens epsilon antitoxin for veterinary use Colophonium ...........................................................................1362
............................................................................................5.1-2867 Colophony .................................................................................1362
Clostridium perfringens vaccine for veterinary use ........... 747 Coloration of liquids (2.2.2.)...................................................... 24
Clostridium septicum vaccine for veterinary use................ 749 Common stinging nettle for homoeopathic preparations.. 895
Closures and containers for parenteral preparations and Comparative table of porosity of sintered-glass filters
ophthalmic preparations, polypropylene for (3.1.6.)........ 282 (2.1.2.)............................................................................................17
Closures and containers for pharmaceutical use, plastic Complexometric titrations (2.5.11.)........................................ 130
(3.2.2.) ........................................................................................ 308 Composition of fatty acids by gas chromatography
Closures and tubing, silicone elastomer for (3.1.9.)........... 288 (2.4.22.) .......................................................................................110
Closures for containers for aqueous parenteral preparations, Composition of fatty acids in oils rich in omega-3-acids
for powders and for freeze-dried powders, rubber (2.4.29.) ...................................................................................... 121
(3.2.9.) .........................................................................................316 Compressed lozenges................................................................ 613
Clotrimazole..............................................................................1333 Compressi.................................................................................... 626
Clotrimazolum .........................................................................1333 Concentrated solutions for haemodialysis ......................... 1700
Clove ...........................................................................................1334 Concentrates for injections or infusions......................5.1-2842
Clove oil .....................................................................................1335 Conductivity (2.2.38.).......................................................5.1-2783
Cloxacillin sodium....................................................................1335 Conjugated estrogens .............................................................1539
Cloxacillinum natricum ........................................................1335 Containers (3.2.)......................................................................... 303
Clozapine ...................................................................................1337 Containers and closures for parenteral preparations and
Clozapinum ..............................................................................1337 ophthalmic preparations, polypropylene for (3.1.6.)........ 282
Coagulation factor II, assay of (2.7.18.)................................. 209 Containers and closures for pharmaceutical use, plastic
Coagulation factor IX, assay of (2.7.11.)................................ 204 (3.2.2.) ........................................................................................ 308
Coagulation factor IX, human............................................... 1738 Containers and tubing for total parenteral nutrition
Coagulation factors, activated (2.6.22.)................................. 177 preparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285
Coagulation factors, assay of heparin (2.7.12.) ................... 204 Containers for aqueous solutions for intravenous infusion,
Coagulation factor VII, assay of (2.7.10.).............................. 203 materials based on plasticised poly(vinyl chloride) for
Coagulation factor VII, human ............................................. 1734 (3.1.14.) ...................................................................................... 296
Coagulation factor VIII, assay of (2.7.4.)............................... 194 Containers for aqueous solutions for parenteral infusion,
Coagulation factor VIII, human............................................ 1736 plastic (3.2.2.1.) ........................................................................ 309
Coagulation factor VIII (rDNA), human ............................. 1737 Containers for dry dosage forms for oral administration,
Coagulation factor X, assay of (2.7.19.)..................................210 materials based on non-plasticised poly(vinyl chloride) for
Coagulation factor XI, assay of (2.7.22.) ............................... 212 (3.1.11.)....................................................................................... 291
Coagulation factor XI, human............................................... 1739 Containers for human blood and blood components,
Coated granules ......................................................................... 606 materials based on plasticised poly(vinyl chloride) for
Coated tablets ............................................................................. 627 (3.1.1.1.) ..................................................................................... 269
Cocaine hydrochloride............................................................1338 Containers for human blood and blood components,
Cocaini hydrochloridum.......................................................1338 materials for (3.1.1.) ................................................................ 269
Cocois oleum raffinatum.......................................................1339 Containers for human blood and blood components, plastic,
Coconut oil, refined.................................................................1339 sterile (3.2.3.) ............................................................................ 309
Cocoyl caprylocaprate.............................................................1340 Containers for non-injectable aqueous solutions, materials
Cocoylis caprylocapras..........................................................1340 based on non-plasticised poly(vinyl chloride) for
Codeine ...............................................................................5.1-2905 (3.1.10.) ...................................................................................... 289
Codeine hydrochloride dihydrate..................................5.1-2906 Containers for parenteral preparations and for ophthalmic
Codeine phosphate hemihydrate...................................5.1-2908 preparations, polyethylene with additives for (3.1.5.) ..... 279
Codeine phosphate sesquihydrate ................................5.1-2909 Containers for parenteral preparations and for ophthalmic
Codeini hydrochloridum dihydricum.........................5.1-2906 preparations, polyethylene without additives for
Codeini phosphas hemihydricus .................................5.1-2908 (3.1.4.)......................................................................................... 278
Codeini phosphas sesquihydricus ...............................5.1-2909 Containers for pharmaceutical use, glass (3.2.1.)............... 303
Codeinum...........................................................................5.1-2905 Containers for preparations not for parenteral use,
Codergocrine mesilate ............................................................1347 polyethylene terephthalate for (3.1.15) .............................. 298
Codergocrini mesilas .............................................................1347 Containers of plasticised poly(vinyl chloride) for human
Cod-liver oil (type A)................................................................1348 blood and blood components, empty sterile (3.2.4.).........311

General Notices (1) apply to all monographs and other texts 3057
Index EUROPEAN PHARMACOPOEIA 5.1

Containers of plasticised poly (vinyl chloride) for human Cysteini hydrochloridum monohydricum........................ 1381
blood containing anticoagulant solution, sterile (3.2.5.).. 312 Cystine........................................................................................1382
Contamination, microbial, test for specified micro-organisms Cystinum ...................................................................................1382
(2.6.13.) ...................................................................................... 156 Cytarabine .................................................................................1383
Contamination, microbial, total viable aerobic count Cytarabinum.............................................................................1383
(2.6.12.) ...................................................................................... 154
Content uniformity of single-dose preparations (2.9.6.).... 234 D
Control of impurities in substances for pharmaceutical use Dalteparin sodium ...................................................................1387
(5.10.).......................................................................................... 559 Dalteparinum natricum ........................................................1387
Copolymerum methacrylatis butylati basicum ............... 1053 Dapsone .....................................................................................1388
Copovidone................................................................................1363 Dapsonum.................................................................................1388
Copovidonum...........................................................................1363 Daunorubicin hydrochloride .................................................1389
Copper for homoeopathic preparations................................ 896 Daunorubicini hydrochloridum..........................................1389
Copper sulphate, anhydrous..................................................1364 D-Camphor ................................................................................. 1170
Copper sulphate pentahydrate..............................................1365 D-Camphora .............................................................................. 1170
Coriander ...................................................................................1365 Decylis oleas.............................................................................1390
Coriander oil .............................................................................1366 Decyl oleate ...............................................................................1390
Coriandri aetheroleum ..........................................................1366 Deferoxamine mesilate............................................................1390
Coriandri fructus ....................................................................1365 Deferoxamini mesilas ............................................................1390
Corpora ad usum pharmaceuticum ..................................... 586 Degree of coloration of liquids (2.2.2.).................................... 24
Cortisone acetate .....................................................................1367 Deliverable mass or volume of liquid and semi-solid
Cortisoni acetas.......................................................................1367 preparations, test for (2.9.28.)............................................... 263
Cotton, absorbent ....................................................................1369 Demeclocycline hydrochloride..............................................1392
Cottonseed oil, hydrogenated ..............................................1370 Demeclocyclini hydrochloridum ........................................1392
Couch grass rhizome .............................................................. 1371 Density of solids (2.2.42.)........................................................... 64
Crataegi folii cum flore extractum siccum....................... 1714 Density, relative (2.2.5.) .............................................................. 27
Crataegi folium cum flore..................................................... 1713 Dental type silica...................................................................... 2411
Crataegi fructus ....................................................................... 1712 Depressor substances (2.6.11.)................................................ 153
Creams.......................................................................................... 625 Deptropine citrate....................................................................1393
Cresol, crude ............................................................................. 1371 Deptropini citras .....................................................................1393
Cresolum crudum ................................................................... 1371 Dequalinii chloridum.............................................................1394
Croci stigma ad praeparationes homoeopathicas............ 900 Dequalinium chloride..............................................................1394
Croscarmellose sodium........................................................... 1371 Desipramine hydrochloride ...................................................1395
Crospovidone ............................................................................1373 Desipramini hydrochloridum ..............................................1395
Crospovidonum .......................................................................1373 Deslanoside ...............................................................................1396
Crotamiton ................................................................................ 1374 Deslanosidum ..........................................................................1396
Crotamitonum.......................................................................... 1374 Desmopressin............................................................................1397
Cupri sulfas anhydricus ........................................................1364 Desmopressinum.....................................................................1397
Cupri sulfas pentahydricus ..................................................1365 Desoxycortone acetate............................................................1399
Cuprum ad praeparationes homoeopathicas .................... 896 Desoxycortoni acetas .............................................................1399
Curcumae xanthorrhizae rhizoma.....................................2645 Detector tubes, gas (2.1.6.) .........................................................19
Cutaneous application, liquid preparations for................... 607 Determination of essential oils in vegetable drugs
Cutaneous application, powders for .......................................616 (2.8.12.) .......................................................................................217
Cutaneous application, semi-solid preparations for ........... 624 Determination of nitrogen by sulphuric acid digestion
Cutaneous application, veterinary liquid preparations (2.5.9.) ........................................................................................ 129
for ................................................................................................ 630 Determination of primary aromatic amino-nitrogen
Cutaneous foams........................................................................ 608 (2.5.8.) ........................................................................................ 129
Cyamopsidis seminis pulvis................................................. 1694 Determination of tannins in herbal drugs (2.8.14.)............ 221
Cyanocobalamin .......................................................................1375 Determination of water by distillation (2.2.13.) .................... 32
Cyanocobalamin (57Co) capsules .............................................819 Detomidine hydrochloride for veterinary use ................... 1400
Cyanocobalamin (57Co) solution ............................................. 820 Detomidini hydrochloridum ad usum veterinarium..... 1400
Cyanocobalamin (58Co) capsules ............................................ 821 Devil’s claw root ....................................................................... 1401
Cyanocobalamin (58Co) solution ............................................. 822 Dexamethasone ........................................................................ 1402
Cyanocobalamini (57Co) capsulae .........................................819 Dexamethasone acetate.......................................................... 1403
Cyanocobalamini (57Co) solutio ............................................ 820 Dexamethasone sodium phosphate ..................................... 1404
Cyanocobalamini (58Co) capsulae ........................................ 821 Dexamethasoni acetas ........................................................... 1403
Cyanocobalamini (58Co) solutio ............................................ 822 Dexamethasoni natrii phosphas ......................................... 1404
Cyanocobalaminum ...............................................................1375 Dexamethasonum ................................................................... 1402
Cyclizine hydrochloride.......................................................... 1376 Dexchlorpheniramine maleate .............................................. 1406
Cyclizini hydrochloridum..................................................... 1376 Dexchlorpheniramini maleas .............................................. 1406
Cyclopentolate hydrochloride ...............................................1377 Dexpanthenol............................................................................ 1407
Cyclopentolati hydrochloridum ..........................................1377 Dexpanthenolum..................................................................... 1407
Cyclophosphamide...................................................................1378 Dextran 1 for injection............................................................ 1408
Cyclophosphamidum .............................................................1378 Dextran 40 for injection ......................................................... 1409
Cyproheptadine hydrochloride .............................................1379 Dextran 60 for injection ......................................................... 1410
Cyproheptadini hydrochloridum ........................................1379 Dextran 70 for injection ..........................................................1411
Cyproterone acetate ................................................................1380 Dextrans, molecular mass distribution in (2.2.39.) .............. 57
Cyproteroni acetas..................................................................1380 Dextranum 1 ad iniectabile ................................................. 1408
Cysteine hydrochloride monohydrate ................................. 1381 Dextranum 40 ad iniectabile ............................................... 1409

3058 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Dextranum 60 ad iniectabile ............................................... 1410 Dimethylacetamide ...........................................................5.1-2915


Dextranum 70 ad iniectabile ................................................1411 Dimethylacetamidum......................................................5.1-2915
Dextrin........................................................................................ 1412 Dimethylaniline, N,N- (2.4.26.).................................................119
Dextrinum ................................................................................. 1412 Dimethylis sulfoxidum........................................................... 1445
Dextromethorphan hydrobromide ....................................... 1412 Dimethyl sulfoxide ................................................................... 1445
Dextromethorphani hydrobromidum ................................ 1412 Dimeticone ................................................................................ 1447
Dextromoramide tartrate ........................................................1414 Dimeticonum............................................................................ 1447
Dextromoramidi tartras..........................................................1414 Dimetindene maleate .............................................................. 1448
Dextropropoxyphene hydrochloride.....................................1414 Dimetindeni maleas ............................................................... 1448
Dextropropoxypheni hydrochloridum................................1414 Dinatrii edetas ......................................................................... 1462
Diazepam ................................................................................... 1415 Dinatrii phosphas anhydricus............................................. 1463
Diazepamum ............................................................................ 1415 Dinatrii phosphas dihydricus .............................................. 1464
Diazoxide ................................................................................... 1416 Dinatrii phosphas dodecahydricus ............................. 5.1-2916
Diazoxidum .............................................................................. 1416 Dinitrogenii oxidum........................................................5.1-2981
Dibutylis phthalas ....................................................................1417 Dinoprostone ............................................................................ 1450
Dibutyl phthalate ......................................................................1417 Dinoprostonum........................................................................ 1450
Dichloromethane...................................................................... 2017 Dinoprost trometamol............................................................. 1449
Diclazuril for veterinary use.................................................. 1418 Dinoprostum trometamolum ............................................... 1449
Diclazurilum ad usum veterinarium................................. 1418 Diosmin ...................................................................................... 1452
Diclofenac potassium .............................................................. 1419 Diosminum ............................................................................... 1452
Diclofenac sodium ................................................................... 1420 Dioxan and ethylene oxide (2.4.25.) .......................................118
Diclofenacum kalicum........................................................... 1419 Dip concentrates ........................................................................ 630
Diclofenacum natricum ........................................................ 1420 Diphenhydramine hydrochloride.......................................... 1454
Dicloxacillin sodium ................................................................ 1422 Diphenhydramini hydrochloridum.................................... 1454
Dicloxacillinum natricum..................................................... 1422 Diphenoxylate hydrochloride ................................................ 1455
Dicycloverine hydrochloride.................................................. 1423 Diphenoxylati hydrochloridum........................................... 1455
Dicycloverini hydrochloridum ............................................ 1423 Diphtheria and tetanus vaccine (adsorbed) ......................... 639
Dienestrol .................................................................................. 1424 Diphtheria and tetanus vaccine (adsorbed) for adults and
Dienestrolum............................................................................ 1424 adolescents................................................................................ 639
Diethylcarbamazine citrate.................................................... 1426 Diphtheria antitoxin .................................................................. 801
Diethylcarbamazini citras .................................................... 1426 Diphtheria, tetanus and hepatitis B (rDNA) vaccine
Diethylene glycol and ethylene glycol in ethoxylated (adsorbed).................................................................................. 641
substances (2.4.30.)................................................................. 122 Diphtheria, tetanus and pertussis (acellular, component)
Diethylene glycol monoethyl ether...................................... 1426 vaccine (adsorbed)................................................................... 642
Diethylene glycol monopalmitostearate ............................. 1428 Diphtheria, tetanus and pertussis vaccine (adsorbed) ..... 643
Diethylenglycoli monoethylicum aetherum .................... 1426 Diphtheria, tetanus, pertussis (acellular, component) and
Diethylenglycoli monopalmitostearas............................... 1428 haemophilus type b conjugate vaccine (adsorbed) .......... 645
Diethylis phthalas ................................................................... 1425 Diphtheria, tetanus, pertussis (acellular, component) and
Diethyl phthalate ..................................................................... 1425 hepatitis B (rDNA) vaccine (adsorbed) ............................... 647
Diethylstilbestrol ...................................................................... 1429 Diphtheria, tetanus, pertussis (acellular, component) and
Diethylstilbestrolum ............................................................... 1429 poliomyelitis (inactivated) vaccine (adsorbed) .................. 648
Diflunisal.................................................................................... 1429 Diphtheria, tetanus, pertussis (acellular, component),
Diflunisalum ............................................................................ 1429 hepatitis B (rDNA), poliomyelitis (inactivated) and
Digitalis leaf .............................................................................. 1431 haemophilus type b conjugate vaccine (adsorbed) .......... 650
Digitalis purpureae folium ................................................... 1431 Diphtheria, tetanus, pertussis (acellular, component),
Digitoxin..................................................................................... 1432 poliomyelitis (inactivated) and haemophilus type b
Digitoxinum.............................................................................. 1432 conjugate vaccine (adsorbed)................................................ 653
Digoxin ....................................................................................... 1433 Diphtheria, tetanus, pertussis and poliomyelitis (inactivated)
Digoxinum ................................................................................ 1433 vaccine (adsorbed)................................................................... 656
Dihydralazine sulphate, hydrated ........................................ 1434 Diphtheria, tetanus, pertussis, poliomyelitis (inactivated) and
Dihydralazini sulfas hydricus.............................................. 1434 haemophilus type b conjugate vaccine (adsorbed) .......... 657
Dihydrocodeine hydrogen tartrate....................................... 1435 Diphtheria vaccine (adsorbed) ................................................ 660
Dihydrocodeini hydrogenotartras ...................................... 1435 Diphtheria vaccine (adsorbed), assay of (2.7.6.).................. 196
Dihydroergocristine mesilate ................................................ 1437 Diphtheria vaccine (adsorbed) for adults and
Dihydroergocristini mesilas................................................. 1437 adolescents................................................................................ 661
Dihydroergotamine mesilate ................................................. 1439 Dipivefrine hydrochloride ...................................................... 1456
Dihydroergotamine tartrate .................................................. 1440 Dipivefrini hydrochloridum ................................................. 1456
Dihydroergotamini mesilas.................................................. 1439 Dipotassium clorazepate ........................................................ 1457
Dihydroergotamini tartras.................................................... 1440 Dipotassium phosphate .......................................................... 1458
Dihydrostreptomycini sulfas ad usum veterinarium..... 1441 Diprophylline ............................................................................ 1459
Dihydrostreptomycin sulphate for veterinary use ............ 1441 Diprophyllinum ....................................................................... 1459
Dikalii clorazepas ................................................................... 1457 Dipyridamole............................................................................. 1460
Dikalii phosphas...................................................................... 1458 Dipyridamolum ....................................................................... 1460
Diltiazem hydrochloride ......................................................... 1443 Dirithromycin............................................................................ 1461
Diltiazemi hydrochloridum.................................................. 1443 Dirithromycinum .................................................................... 1461
Dimenhydrinate........................................................................ 1444 Disintegration of suppositories and pessaries (2.9.2.)....... 227
Dimenhydrinatum .................................................................. 1444 Disintegration of tablets and capsules (2.9.1.) .................... 225
Dimercaprol............................................................................... 1445 Disodium edetate ..................................................................... 1462
Dimercaprolum........................................................................ 1445 Disodium phosphate, anhydrous.......................................... 1463

General Notices (1) apply to all monographs and other texts 3059
Index EUROPEAN PHARMACOPOEIA 5.1

Disodium phosphate dihydrate............................................. 1464 Edrophonium chloride............................................................ 1495


Disodium phosphate dodecahydrate ............................ 5.1-2916 Effervescent granules................................................................ 606
Disopyramide ............................................................................ 1465 Effervescent powders .................................................................617
Disopyramide phosphate........................................................ 1466 Effervescent tablets ................................................................... 627
Disopyramidi phosphas......................................................... 1466 Efficacy of antimicrobial preservation (5.1.3.)..................... 447
Disopyramidum....................................................................... 1465 Egg drop syndrome ’76 vaccine (inactivated)...................... 753
Dispersible tablets ..................................................................... 628 Elder flower............................................................................... 1496
Dissolution test for solid dosage forms (2.9.3.)................... 228 Electrophoresis (2.2.31.)............................................................. 45
Dissolution test for transdermal patches (2.9.4.)................ 231 Electrophoresis, capillary (2.2.47.)............................................74
Distemper vaccine (live), canine, freeze-dried...................... 740 Eleutherococci radix .............................................................. 1497
Distemper vaccine (live) for mustelids, freeze-dried........... 751 Eleutherococcus....................................................................... 1497
Distillation range (2.2.11.).......................................................... 30 Emetine hydrochloride heptahydrate.................................. 1499
Disulfiram .................................................................................. 1467 Emetine hydrochloride pentahydrate..................................1500
Disulfiramum ........................................................................... 1467 Emetini hydrochloridum heptahydricum......................... 1499
Dithranol.................................................................................... 1468 Emetini hydrochloridum pentahydricum ........................1500
Dithranolum ............................................................................. 1468 Emplastra transcutanea ...........................................................616
DL-Methionine ........................................................................... 2010 Empty sterile containers of plasticised poly(vinyl chloride)
DL-Methioninum ...................................................................... 2010 for human blood and blood components (3.2.4.) ..............311
DL-α-Tocopheryl hydrogen succinate...................................2597 Emulsifying cetostearyl alcohol (type A) ............................1239
DL-α-Tocopherylis hydrogenosuccinas..............................2597 Emulsifying cetostearyl alcohol (type B)............................ 1241
Dobutamine hydrochloride.................................................... 1469 Enalaprili maleas............................................................. 5.1-2919
Dobutamini hydrochloridum ............................................... 1469 Enalapril maleate .............................................................. 5.1-2919
Docusate sodium...................................................................... 1471 Endotoxins, bacterial (2.6.14.)..................................................161
Dodecyl gallate ......................................................................... 1472 Enilconazole for veterinary use............................................1503
Dodecylis gallas....................................................................... 1472 Enilconazolum ad usum veterinarium .............................1503
Dog rose..................................................................................... 1472 Enoxaparin sodium..................................................................1504
Domperidone ............................................................................ 1473 Enoxaparinum natricum ......................................................1504
Domperidone maleate............................................................. 1475 Enoxolone..................................................................................1505
Domperidoni maleas.............................................................. 1475 Enoxolonum .............................................................................1505
Domperidonum ....................................................................... 1473 Ephedrine, anhydrous.............................................................1506
Dopamine hydrochloride........................................................ 1476 Ephedrine hemihydrate ..........................................................1507
Dopamini hydrochloridum................................................... 1476 Ephedrine hydrochloride .......................................................1508
Dosulepin hydrochloride........................................................ 1477 Ephedrine hydrochloride, racemic.......................................1509
Dosulepini hydrochloridum ................................................. 1477 Ephedrini hydrochloridum ..................................................1508
Doxapram hydrochloride........................................................ 1479 Ephedrini racemici hydrochloridum.................................1509
Doxaprami hydrochloridum ................................................ 1479 Ephedrinum anhydricum .....................................................1506
Doxepin hydrochloride ........................................................... 1480 Ephedrinum hemihydricum ................................................1507
Doxepini hydrochloridum .................................................... 1480 Epirubicin hydrochloride .......................................................1509
Doxorubicin hydrochloride.................................................... 1481 Epirubicini hydrochloridum................................................1509
Doxorubicini hydrochloridum............................................. 1481 Equine herpesvirus vaccine (inactivated) ............................. 754
Doxycycline hyclate ................................................................. 1482 Equine influenza vaccine (inactivated) ................................. 755
Doxycycline monohydrate...................................................... 1484 Equiseti herba .......................................................................... 1511
Doxycyclini hyclas.................................................................. 1482 Equisetum stem........................................................................ 1511
Doxycyclinum monohydricum............................................ 1484 Ergocalciferol............................................................................ 1512
Doxylamine hydrogen succinate........................................... 1486 Ergocalciferolum..................................................................... 1512
Doxylamini hydrogenosuccinas ......................................... 1486 Ergometrine maleate............................................................... 1514
Droperidol.................................................................................. 1487 Ergometrini maleas................................................................ 1514
Droperidolum........................................................................... 1487 Ergotamine tartrate................................................................. 1515
Droppers (2.1.1.)............................................................................17 Ergotamini tartras .................................................................. 1515
Drop point (2.2.17.)...................................................................... 33 Erysipelas vaccine (inactivated), swine ................................. 793
Dry extracts ................................................................................. 572 Erythritol ................................................................................... 1516
Dry residue of extracts (2.8.16.).............................................. 222 Erythritolum............................................................................. 1516
Duck viral hepatitis type I vaccine (live)............................... 751 Erythromycin ............................................................................ 1518
Erythromycin estolate.............................................................1520
E Erythromycin ethylsuccinate................................................. 1521
Ear-drops and sprays................................................................. 602 Erythromycini estolas............................................................1520
Ear powders ................................................................................ 602 Erythromycini ethylsuccinas............................................... 1521
Ear preparations......................................................................... 601 Erythromycini lactobionas...................................................1523
Ear preparations, semi-solid .................................................... 602 Erythromycini stearas ...........................................................1526
Ear tampons................................................................................ 602 Erythromycin lactobionate ....................................................1523
Ear washes................................................................................... 602 Erythromycin stearate ............................................................1526
Ebastine ..................................................................................... 1491 Erythromycinum..................................................................... 1518
Ebastinum ................................................................................. 1491 Erythropoietin concentrated solution.................................1528
Econazole .................................................................................. 1492 Erythropoietini solutio concentrata...................................1528
Econazole nitrate..................................................................... 1493 Eserine salicylate .....................................................................2239
Econazoli nitras ...................................................................... 1493 Eserine sulphate.......................................................................2240
Econazolum.............................................................................. 1492 Eserini salicylas ......................................................................2239
Edetic acid ................................................................................. 1494 Eserini sulfas............................................................................2240
Edrophonii chloridum ........................................................... 1495 Esketamine hydrochloride .....................................................1533

3060 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Esketamini hydrochloridum ................................................1533 Etofenamate .............................................................................. 1561


Essential oils, assay of 1,8-cineole (2.8.11.)...........................216 Etofenamatum ......................................................................... 1561
Essential oils, fatty oils and resinified essential oils in Etofylline....................................................................................1563
(2.8.7.)..........................................................................................216 Etofyllinum ...............................................................................1563
Essential oils, foreign esters in (2.8.6.) ..................................216 Etomidate ..................................................................................1564
Essential oils in vegetable drugs, determination of Etomidatum ..............................................................................1564
(2.8.12.) .......................................................................................217 Etoposide ...................................................................................1565
Essential oils, odour and taste (2.8.8.) ...................................216 Etoposidum...............................................................................1565
Essential oils, residue on evaporation (2.8.9.)......................216 Eucalypti aetheroleum ..........................................................1570
Essential oils, solubility in alcohol (2.8.10.)..........................216 Eucalypti folium......................................................................1569
Essential oils, water in (2.8.5.) .................................................216 Eucalyptus leaf .........................................................................1569
Ester value (2.5.2.) ..................................................................... 127 Eucalyptus oil ...........................................................................1570
Estradiol benzoate...................................................................1534 Eugenol ...................................................................................... 1571
Estradiol hemihydrate.............................................................1535 Eugenolum................................................................................ 1571
Estradioli benzoas...................................................................1534 European Goldenrod............................................................... 1682
Estradioli valeras.....................................................................1536 European viper venom antiserum.......................................... 806
Estradiolum hemihydricum .................................................1535 Evaluation of efficacy of veterinary vaccines and immunosera
Estradiol valerate .....................................................................1536 (5.2.7.)................................................................................5.1-2829
Estriol .........................................................................................1537 Evaluation of safety of each batch of veterinary vaccines and
Estriolum...................................................................................1537 immunosera (5.2.9.) .......................................................5.1-2830
Estrogeni coniuncti ................................................................1539 Evaluation of safety of veterinary vaccines and immunosera
Estrogens, conjugated ............................................................1539 (5.2.6.) ...............................................................................5.1-2827
Etacrynic acid ...........................................................................1542 Evening primrose oil, refined.........................................5.1-2921
Etamsylate .................................................................................1542 Extracta........................................................................................ 570
Etamsylatum ............................................................................1542 Extractable volume of parenteral preparations, test for
Ethacridine lactate monohydrate.........................................1543 (2.9.17.)....................................................................................... 243
Ethacridini lactas monohydricus .......................................1543 Extracta fluida ........................................................................... 571
Ethambutol hydrochloride.....................................................1544 Extracta sicca ............................................................................. 572
Ethambutoli hydrochloridum ..............................................1544 Extracta spissa ........................................................................... 572
Ethanol (96 per cent) ..............................................................1545 Extracts ........................................................................................ 570
Ethanol, anhydrous .................................................................1547 Extracts, dry ................................................................................ 572
Ethanol content and alcoholimetric tables (2.9.10.) .......... 237 Extracts, dry residue of (2.8.16.)............................................. 222
Ethanolum (96 per centum).................................................1545 Extracts, liquid............................................................................ 571
Ethanolum anhydricum ........................................................1547 Extracts, loss on drying of (2.8.17.)........................................ 222
Ether ...........................................................................................1548 Extracts, soft ............................................................................... 572
Ether, anaesthetic....................................................................1549 Extraneous agents in viral vaccines for human use, tests for
Ethinylestradiol ........................................................................1550 (2.6.16.) ...................................................................................... 169
Ethinylestradiolum .................................................................1550 Extraneous agents : tests in batches of finished product of
Ethionamide.............................................................................. 1551 avian live virus vaccines (2.6.25.)......................................... 180
Ethionamidum......................................................................... 1551 Extraneous agents : tests in seed lots of avian viral vaccines
Ethosuximide ............................................................................ 1551 (2.6.24.) ...................................................................................... 177
Ethosuximidum ....................................................................... 1551 Eye-drops ..................................................................................... 603
Ethoxylated substances, ethylene glycol and diethylene Eye lotions................................................................................... 603
glycol in (2.4.30.) ..................................................................... 122 Eye preparations ........................................................................ 602
Ethyl acetate .............................................................................1553 Eye preparations, semi-solid .................................................... 604
Ethylcellulose ...........................................................................1555
Ethylcellulosum .......................................................................1555 F
Ethylendiaminum ...................................................................1556 F0 concept to steam sterilisation of aqueous preparations,
Ethylenediamine ......................................................................1556 application of (5.1.5.) .....................................................5.1-2821
Ethylene glycol and diethylene glycol in ethoxylated Factor II, human coagulation, assay of (2.7.18.) ................. 209
substances (2.4.30.)................................................................. 122 Factor IX coagulationis humanus ...................................... 1738
Ethylene glycol monopalmitostearate.................................1556 Factor IX, human coagulation .............................................. 1738
Ethylene glycol monostearate...............................................1556 Factor IX, human coagulation, assay of (2.7.11.) ................ 204
Ethylene oxide and dioxan (2.4.25.) .......................................118 Factor VII coagulationis humanus .................................... 1734
Ethylenglycoli monopalmitostearas...................................1556 Factor VII, human coagulation............................................. 1734
Ethylhexanoic acid, 2- (2.4.28.)............................................... 120 Factor VII, human coagulation, assay of (2.7.10.) .............. 203
Ethylis acetas ...........................................................................1553 Factor VIII coagulationis humanus................................... 1736
Ethylis oleas..............................................................................1553 Factor VIII coagulationis humanus (ADNr) .................... 1737
Ethylis parahydroxybenzoas................................................1554 Factor VIII, human coagulation ........................................... 1736
Ethylis parahydroxybenzoas natricum ......................5.1-2920 Factor VIII, human coagulation, assay of (2.7.4.) ............... 194
Ethylmorphine hydrochloride...............................................1557 Factor VIII (rDNA), human coagulation ............................. 1737
Ethylmorphini hydrochloridum..........................................1557 Factor X, human coagulation, assay of (2.7.19.) ..................210
Ethyl oleate ...............................................................................1553 Factor XI coagulationis humanus ...................................... 1739
Ethyl parahydroxybenzoate...................................................1554 Factor XI, human coagulation .............................................. 1739
Ethyl parahydroxybenzoate sodium .............................5.1-2920 Factor XI, human coagulation, assay of (2.7.22.)................ 212
Etilefrine hydrochloride .........................................................1558 Falling ball viscometer method (2.2.49.) ................................ 80
Etilefrini hydrochloridum.....................................................1558 Famotidine.................................................................................1575
Etodolac .....................................................................................1560 Famotidinum............................................................................1575
Etodolacum...............................................................................1560

General Notices (1) apply to all monographs and other texts 3061
Index EUROPEAN PHARMACOPOEIA 5.1

Fatty acids, composition by gas chromatography Filum polyamidicum-6/6 sterile in fuso ad usum
(2.4.22.) .......................................................................................110 veterinarium ............................................................................ 887
Fatty oils, alkaline impurities in (2.4.19.) ............................. 109 Filum polyamidicum-6 sterile in fuso ad usum
Fatty oils and herbal drugs, heavy metals in (2.4.27.) ........119 veterinarium ............................................................................ 886
Fatty oils and resinified essential oils in essential oils Finasteride.................................................................................1594
(2.8.7.)..........................................................................................216 Finasteridum............................................................................1594
Fatty oils, foreign oils in, by thin-layer chromatography Fish oil, rich in omega-3-acids...............................................1595
(2.4.21.) ...................................................................................... 109 Flecainide acetate ....................................................................1598
Fatty oils, identification by thin-layer chromatography Flecainidi acetas .....................................................................1598
(2.3.2.) .......................................................................................... 98 Flowability (2.9.16.) ................................................................... 242
Fatty oils, sterols in (2.4.23.) ..........................................5.1-2787 Flubendazole ............................................................................1599
Fc function of immunoglobulin, test for (2.7.9.) ................. 202 Flubendazolum........................................................................1599
Feline calicivirosis vaccine (inactivated) ............................... 757 Flucloxacillin sodium .......................................................5.1-2925
Feline calicivirosis vaccine (live), freeze-dried ..................... 758 Flucloxacillinum natricum............................................5.1-2925
Feline infectious enteritis (feline panleucopenia) vaccine Flucytosine ................................................................................ 1602
(inactivated) .............................................................................. 759 Flucytosinum ........................................................................... 1602
Feline infectious enteritis (feline panleucopenia) vaccine Fludarabine phosphate....................................................5.1-2926
(live) ............................................................................................ 760 Fludarabini phosphas .....................................................5.1-2926
Feline leukaemia vaccine (inactivated)...................................761 Fludeoxyglucose (18F) injection .............................................. 822
Feline panleucopenia vaccine (inactivated).......................... 759 Fludeoxyglucosi (18F) solutio iniectabilis ........................... 822
Feline panleucopenia vaccine (live) ....................................... 760 Fludrocortisone acetate.......................................................... 1603
Feline viral rhinotracheitis vaccine (inactivated) ................ 762 Fludrocortisoni acetas ........................................................... 1603
Feline viral rhinotracheitis vaccine (live), freeze-dried ...... 763 Flumazenil................................................................................. 1604
Felodipine .................................................................................. 1576 Flumazenil (N-[11C]methyl) injection ..................................... 825
Felodipinum ............................................................................. 1576 Flumazenil (N-[11C]methyl) solutio iniectabilis................. 825
Fenbendazole for veterinary use ..........................................1577 Flumazenilum.......................................................................... 1604
Fenbendazolum ad usum veterinarium............................1577 Flumequine ............................................................................... 1605
Fenbufen ....................................................................................1578 Flumequinum........................................................................... 1605
Fenbufenum..............................................................................1578 Flumetasone pivalate .............................................................. 1607
Fennel, bitter.............................................................................1580 Flumetasoni pivalas ............................................................... 1607
Fennel, sweet.............................................................................1580 Flunarizine dihydrochloride.................................................. 1608
Fenofibrate ................................................................................ 1581 Flunarizini dihydrochloridum ............................................ 1608
Fenofibratum............................................................................ 1581 Flunitrazepam........................................................................... 1609
Fenoterol hydrobromide.........................................................1583 Flunitrazepamum ................................................................... 1609
Fenoteroli hydrobromidum ..................................................1583 Flunixini megluminum ad usum veterinarium.......5.1-2929
Fentanyl .....................................................................................1584 Flunixin meglumine for veterinary use........................5.1-2929
Fentanyl citrate.........................................................................1585 Fluocinolone acetonide .......................................................... 1610
Fentanyli citras........................................................................1585 Fluocinoloni acetonidum ..................................................... 1610
Fentanylum...............................................................................1584 Fluocortolone pivalate............................................................ 1611
Fenticonazole nitrate ..............................................................1586 Fluocortoloni pivalas ............................................................. 1611
Fenticonazoli nitras ...............................................................1586 Fluorescein sodium ................................................................. 1613
Fenugreek..................................................................................1588 Fluoresceinum natricum ...................................................... 1613
Fermentation, products of ....................................................... 576 Fluorides (2.4.5.) ........................................................................ 104
Ferric chloride hexahydrate ..................................................1588 Fluorimetry (2.2.21.) ................................................................... 35
Ferri chloridum hexahydricum...........................................1588 Fluorouracil............................................................................... 1614
Ferrosi fumaras .......................................................................1589 Fluorouracilum........................................................................ 1614
Ferrosi gluconas......................................................................1590 Fluoxetine hydrochloride ....................................................... 1615
Ferrosi sulfas heptahydricus................................................ 1591 Fluoxetini hydrochloridum .................................................. 1615
Ferrous fumarate .....................................................................1589 Flupentixol dihydrochloride ...................................................1617
Ferrous gluconate....................................................................1590 Flupentixoli dihydrochloridum ............................................1617
Ferrous sulphate heptahydrate............................................. 1591 Fluphenazine decanoate ........................................................ 1619
Ferrum ad praeparationes homoeopathicas ..................... 899 Fluphenazine enantate ........................................................... 1620
Feverfew .....................................................................................1592 Fluphenazine hydrochloride ................................................. 1621
Fibrini glutinum......................................................................1593 Fluphenazini decanoas ......................................................... 1619
Fibrinogen, human .................................................................. 1740 Fluphenazini enantas............................................................ 1620
Fibrinogenum humanum ..................................................... 1740 Fluphenazini hydrochloridum ............................................ 1621
Fibrin sealant kit ......................................................................1593 Flurazepami monohydrochloridum................................... 1622
Fila non resorbilia sterilia...................................................... 874 Flurazepam monohydrochloride .......................................... 1622
Fila non resorbilia sterilia in fuso ad usum Flurbiprofen .............................................................................. 1623
veterinarium ............................................................................ 888 Flurbiprofenum ....................................................................... 1623
Fila resorbilia synthetica monofilamenta sterilia............ 880 Fluspirilene ............................................................................... 1625
Fila resorbilia synthetica torta sterilia................................ 878 Fluspirilenum .......................................................................... 1625
Filipendulae ulmariae herba ............................................... 1980 Flutamide................................................................................... 1626
Filum bombycis tortum sterile in fuso ad usum Flutamidum .............................................................................. 1626
veterinarium ............................................................................ 887 Fluticasone propionate........................................................... 1627
Filum ethyleni polyterephthalici sterile in fuso ad usum Fluticasoni propionas............................................................ 1627
veterinarium ............................................................................ 887 Flutrimazole.............................................................................. 1629
Filum lini sterile in fuso ad usum veterinarium .............. 886 Flutrimazolum ......................................................................... 1629
Foams, cutaneous ...................................................................... 608

3062 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Foams, medicated ...................................................................... 604 Gas-gangrene antitoxin, mixed ................................................ 802


Foams, rectal............................................................................... 624 Gas-gangrene antitoxin (novyi) ............................................... 802
Foams, vaginal ............................................................................ 630 Gas-gangrene antitoxin (perfringens) .................................... 803
Foeniculi amari fructus.........................................................1580 Gas-gangrene antitoxin (septicum)......................................... 804
Foeniculi amari fructus aetheroleum................................ 1108 Gastro-resistant capsules.......................................................... 600
Foeniculi dulcis fructus.........................................................1580 Gastro-resistant granules.......................................................... 606
Folic acid.................................................................................... 1630 Gastro-resistant tablets ............................................................. 628
Foot-and-mouth disease (ruminants) vaccine Gelatin ........................................................................................ 1651
(inactivated) .....................................................................5.1-2860 Gelatina ..................................................................................... 1651
Foreign esters in essential oils (2.8.6.) ...................................216 Gels................................................................................................ 625
Foreign matter (2.8.2.) .............................................................. 215 Gels for injections .............................................................5.1-2843
Foreign oils in fatty oils by thin-layer chromatography General chapters (1.3.)...................................................................6
(2.4.21.) ...................................................................................... 109 General notices (1.).........................................................................5
Formaldehyde, free (2.4.18.) .................................................... 109 General statements (1.1.)...............................................................5
Formaldehyde solution (35 per cent) .................................. 1632 General texts on sterility (5.1.)................................................ 445
Formaldehydi solutio (35 per centum).............................. 1632 General texts on vaccines (5.2.) .............................................. 453
Formoterol fumarate dihydrate ............................................ 1632 Gentamicini sulfas .................................................................. 1653
Formoteroli fumaras dihydricus ......................................... 1632 Gentamicin sulphate................................................................ 1653
Foscarnet sodium hexahydrate............................................. 1634 Gentianae radix ....................................................................... 1654
Foscarnetum natricum hexahydricum.............................. 1634 Gentianae tinctura.................................................................. 1655
Fosfomycin calcium ................................................................. 1636 Gentian root .............................................................................. 1654
Fosfomycin sodium.................................................................. 1637 Gentian tincture ....................................................................... 1655
Fosfomycin trometamol .......................................................... 1638 Ginger ......................................................................................... 1656
Fosfomycinum calcicum ....................................................... 1636 Gingival solutions ...................................................................... 612
Fosfomycinum natricum....................................................... 1637 Ginkgo folium .......................................................................... 1657
Fosfomycinum trometamolum ............................................ 1638 Ginkgo leaf ................................................................................ 1657
Fowl cholera vaccine (inactivated) ................................5.1-2861 Ginseng................................................................................5.1-2935
Fowl-pox vaccine (live) .............................................................. 766 Ginseng radix ....................................................................5.1-2935
Framycetini sulfas .................................................................. 1639 Glass containers for pharmaceutical use (3.2.1.) ................ 303
Framycetin sulphate................................................................ 1639 Glibenclamide ........................................................................... 1659
Frangula bark ........................................................................... 1641 Glibenclamidum ...................................................................... 1659
Frangula bark dry extract, standardised ............................ 1642 Gliclazide.................................................................................... 1660
Frangulae cortex ..................................................................... 1641 Gliclazidum............................................................................... 1660
Frangulae corticis extractum siccum normatum ........... 1642 Glipizide ..................................................................................... 1662
Fraxini folium .......................................................................... 1026 Glipizidum ................................................................................ 1662
Free formaldehyde (2.4.18.)..................................................... 109 Glossary (dosage forms) ........................................................... 599
Freezing point (2.2.18.)............................................................... 34 Glucagon .................................................................................... 1663
Friability of uncoated tablets (2.9.7.)..................................... 234 Glucagon, human..................................................................... 1665
Fructose .................................................................................... 1643 Glucagonum ............................................................................. 1663
Fructosum ................................................................................. 1643 Glucagonum humanum ........................................................ 1665
Fucus .......................................................................................... 1869 Glucose, anhydrous ................................................................. 1666
Fucus vel Ascophyllum.......................................................... 1869 Glucose, liquid .......................................................................... 1667
Functional groups and ions, identification reactions Glucose, liquid, spray-dried.................................................... 1668
(2.3.1.)........................................................................................... 95 Glucose monohydrate ............................................................. 1669
Furosemide.........................................................................5.1-2930 Glucosum anhydricum .......................................................... 1666
Furosemidum....................................................................5.1-2930 Glucosum liquidum ................................................................ 1667
Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) Glucosum liquidum dispersione desiccatum................... 1668
for salmonids ............................................................................ 767 Glucosum monohydricum .................................................... 1669
Fusidic acid ............................................................................... 1645 Glutamic acid ............................................................................ 1670
Glutathione.........................................................................5.1-2936
G Glutathionum ....................................................................5.1-2936
Galactose.................................................................................... 1649 Glycerol ...................................................................................... 1671
Galactosum ............................................................................... 1649 Glycerol (85 per cent).............................................................. 1672
Gallamine triethiodide ............................................................ 1649 Glycerol dibehenate..........................................................5.1-2938
Gallamini triethiodidum ....................................................... 1649 Glycerol distearate .................................................................. 1674
Gallii (67Ga) citratis solutio iniectabilis ............................... 826 Glyceroli dibehenas .........................................................5.1-2938
Gallium (67Ga) citrate injection ............................................... 826 Glyceroli distearas .................................................................. 1674
Gargles.......................................................................................... 612 Glyceroli monolinoleas ........................................................ 1675
Garlic for homoeopathic preparations .................................. 897 Glyceroli mono-oleates .......................................................... 1676
Garlic powder............................................................................ 1651 Glyceroli monostearas 40-55................................................ 1677
Gas chromatography (2.2.28.) ................................................... 42 Glyceroli trinitratis solutio ................................................... 1678
Gas detector tubes (2.1.6.) ..........................................................19 Glycerol monolinoleate........................................................... 1675
Gases, carbon dioxide in (2.5.24.)........................................... 134 Glycerol mono-oleates ............................................................ 1676
Gases, carbon monoxide in (2.5.25.)...................................... 134 Glycerol monostearate 40-55................................................. 1677
Gases, nitrogen monoxide and nitrogen dioxide in Glycerol triacetate.................................................................... 2612
(2.5.26.) ...................................................................................... 135 Glycerolum................................................................................ 1671
Gases, nitrous oxide in (2.5.35.)...............................................141 Glycerolum (85 per centum) ................................................ 1672
Gases, oxygen in (2.5.27.) ......................................................... 136 Glyceryl trinitrate solution..................................................... 1678
Gases, water in (2.5.28.)............................................................ 136 Glycine........................................................................................ 1680

General Notices (1) apply to all monographs and other texts 3063
Index EUROPEAN PHARMACOPOEIA 5.1

Glycinum ................................................................................... 1680 Hawthorn leaf and flower dry extract ................................. 1714
Glycyrrhizate ammonium ................................................5.1-2876 Heavy bismuth subnitrate ...................................................... 1107
Goldenrod .................................................................................. 1680 Heavy kaolin.............................................................................. 1869
Goldenrod, European.............................................................. 1682 Heavy magnesium carbonate ................................................ 1954
Goldenseal rhizome................................................................. 1683 Heavy magnesium oxide......................................................... 1958
Gonadorelin acetate ................................................................ 1684 Heavy metals (2.4.8.) ................................................................. 104
Gonadorelini acetas ............................................................... 1684 Heavy metals in herbal drugs and fatty oils (2.4.27.)..........119
Gonadotrophin, chorionic ...................................................... 1686 Hederae folium .................................................................5.1-2954
Gonadotrophin, equine serum, for veterinary use............ 1686 Helianthi annui oleum raffinatum.....................................2524
Gonadotropinum chorionicum ........................................... 1686 Heparina massae molecularis minoris ..............................1717
Gonadotropinum sericum equinum ad usum Heparin, assay of (2.7.5.) .......................................................... 195
veterinarium .......................................................................... 1686 Heparin calcium ....................................................................... 1715
Goserelin .................................................................................... 1687 Heparin in coagulation factors, assay of (2.7.12.)............... 204
Goserelinum ............................................................................. 1687 Heparins, low-molecular-mass ................................................1717
Gossypii oleum hydrogenatum............................................1370 Heparin sodium ........................................................................ 1716
Gramicidin ................................................................................. 1689 Heparinum calcicum ............................................................. 1715
Gramicidinum.......................................................................... 1689 Heparinum natricum ............................................................. 1716
Graminis rhizoma................................................................... 1371 Hepatitis A immunoglobulin, human ...................................1741
Granisetron hydrochloride..............................................5.1-2939 Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine
Granisetroni hydrochloridum.......................................5.1-2939 (adsorbed).................................................................................. 664
Granulata .................................................................................... 605 Hepatitis A vaccine, assay of (2.7.14.)...........................5.1-2795
Granules ....................................................................................... 605 Hepatitis A vaccine (inactivated, adsorbed) ......................... 665
Granules, coated......................................................................... 606 Hepatitis A vaccine (inactivated, virosome) ......................... 667
Granules, effervescent............................................................... 606 Hepatitis B immunoglobulin for intravenous administration,
Granules, gastro-resistant......................................................... 606 human .......................................................................................1741
Granules, modified-release....................................................... 606 Hepatitis B immunoglobulin, human ...................................1741
Greater celandine..................................................................... 1690 Hepatitis B (rDNA), diphtheria and tetanus vaccine
Griseofulvin ............................................................................... 1691 (adsorbed).................................................................................. 641
Griseofulvinum ........................................................................ 1691 Hepatitis B (rDNA), diphtheria, tetanus and pertussis
Guaifenesin................................................................................ 1692 (acellular, component) vaccine (adsorbed) ........................ 647
Guaifenesinum ........................................................................ 1692 Hepatitis B vaccine (rDNA)...................................................... 670
Guanethidine monosulphate ................................................. 1694 Hepatitis B vaccine (rDNA), assay of (2.7.15.) ..................... 207
Guanethidini monosulfas ..................................................... 1694 Hepatitis C virus (HCV), validation of nucleic acid
Guar ............................................................................................ 1694 amplification techniques for the detection of HCV RNA in
Guar galactomannan ............................................................... 1695 plasma pools : Guidelines........................................................176
Guar galactomannanum....................................................... 1695 Heptaminol hydrochloride..................................................... 1719
Heptaminoli hydrochloridum.............................................. 1719
H Herbal drug preparations......................................................... 572
Haemodiafiltration and for haemofiltration, solutions Herbal drugs ............................................................................... 572
for .............................................................................................. 1703 Herbal drugs and fatty oils, heavy metals in (2.4.27.).........119
Haemodialysis, concentrated solutions for ........................ 1700 Herbal drugs, determination of tannins (2.8.14.) ............... 221
Haemodialysis solutions, concentrated, water for Herbal drugs for homoeopathic preparations ..................... 893
diluting..................................................................................... 1699 Herbal teas................................................................................... 573
Haemodialysis, solutions for.................................................. 1700 Hexamidine diisetionate ......................................................... 1720
Haemofiltration and for haemodiafiltration, solutions Hexamidini diisetionas ......................................................... 1720
for .............................................................................................. 1703 Hexetidine.................................................................................. 1721
Haemophilus type b (conjugate), diphtheria, tetanus, Hexetidinum............................................................................. 1721
pertussis (acellular, component) and poliomyelitis Hexobarbital.............................................................................. 1722
(inactivated) vaccine (adsorbed) ........................................... 653 Hexobarbitalum ....................................................................... 1722
Haemophilus type b (conjugate), diphtheria, tetanus, Hexosamines in polysaccharide vaccines (2.5.20.) ............. 132
pertussis and poliomyelitis (inactivated) vaccine Hexylresorcinol......................................................................... 1723
(adsorbed).................................................................................. 657 Hexylresorcinolum ................................................................. 1723
Haemophilus type b conjugate vaccine................................. 662 Hibisci sabdariffae flos .......................................................... 2376
Halofantrine hydrochloride ................................................... 1705 Highly purified water ..............................................................2695
Halofantrini hydrochloridum .............................................. 1705 Histamine (2.6.10.)..................................................................... 153
Haloperidol................................................................................ 1706 Histamine dihydrochloride .................................................... 1724
Haloperidol decanoate............................................................ 1708 Histamine phosphate .............................................................. 1725
Haloperidoli decanoas........................................................... 1708 Histamini dihydrochloridum ............................................... 1724
Haloperidolum......................................................................... 1706 Histamini phosphas................................................................ 1725
Halothane .................................................................................. 1709 Histidine..............................................................................5.1-2945
Halothanum.............................................................................. 1709 Histidine hydrochloride monohydrate ................................ 1727
Hamamelidis folium............................................................... 1711 Histidini hydrochloridum monohydricum....................... 1727
Hamamelis leaf ......................................................................... 1711 Histidinum .........................................................................5.1-2945
Hard capsules.............................................................................. 600 Homatropine hydrobromide .................................................. 1728
Hard fat ...................................................................................... 1711 Homatropine methylbromide ................................................ 1729
Hard paraffin............................................................................. 2186 Homatropini hydrobromidum ............................................. 1728
Harpagophyti radix ................................................................ 1401 Homatropini methylbromidum ........................................... 1729
Hawthorn berries ..................................................................... 1712 Homoeopathic preparations .................................................... 893
Hawthorn leaf and flower ...................................................... 1713 Homoeopathic preparations, arsenious trioxide for .......... 895

3064 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Homoeopathic preparations, common stinging nettle Hydrogenated arachis oil ....................................................... 1018
for ................................................................................................ 895 Hydrogenated castor oil ......................................................... 1197
Homoeopathic preparations, copper for............................... 896 Hydrogenated cottonseed oil ................................................1370
Homoeopathic preparations, garlic for ................................. 897 Hydrogenated soya-bean oil...................................................2475
Homoeopathic preparations, herbal drugs for .................... 893 Hydrogenated wool fat............................................................2708
Homoeopathic preparations, honey bee for......................... 898 Hydrogenii peroxidum 30 per centum.............................. 1763
Homoeopathic preparations, hypericum for ........................ 898 Hydrogenii peroxidum 3 per centum ................................ 1762
Homoeopathic preparations, iron for .................................... 899 Hydrogen peroxide solution (30 per cent) ......................... 1763
Homoeopathic preparations, mother tinctures for............. 894 Hydrogen peroxide solution (3 per cent)............................ 1762
Homoeopathic preparations, saffron for............................... 900 Hydromorphone hydrochloride ............................................ 1763
Honey ..................................................................................5.1-2946 Hydromorphoni hydrochloridum ....................................... 1763
Honey bee for homoeopathic preparations.......................... 898 Hydrous wool fat......................................................................2709
Hop strobile............................................................................... 1730 Hydroxocobalamin acetate..................................................... 1765
Human albumin injection, iodinated (125I)............................ 827 Hydroxocobalamin chloride................................................... 1766
Human albumin solution ....................................................... 1731 Hydroxocobalamini acetas ................................................... 1765
Human anti-D immunoglobulin ............................................ 1732 Hydroxocobalamini chloridum ........................................... 1766
Human anti-D immunoglobulin, assay of (2.7.13.).............. 205 Hydroxocobalamini sulfas .................................................... 1767
Human anti-D immunoglobulin for intravenous Hydroxocobalamin sulphate .................................................. 1767
administration ........................................................................ 1733 Hydroxycarbamide ................................................................... 1768
Human antithrombin III, assay of (2.7.17.)........................... 209 Hydroxycarbamidum ............................................................. 1768
Human antithrombin III concentrate .................................. 1733 Hydroxyethylcellulose......................................................5.1-2947
Human coagulation factor II, assay of (2.7.18.)................... 209 Hydroxyethylcellulosum.................................................5.1-2947
Human coagulation factor IX................................................ 1738 Hydroxyethylis salicylas........................................................ 1769
Human coagulation factor IX, assay of (2.7.11.).................. 204 Hydroxyethylmethylcellulose ................................................ 2018
Human coagulation factor VII .............................................. 1734 Hydroxyethyl salicylate........................................................... 1769
Human coagulation factor VII, assay of (2.7.10.) ................ 203 Hydroxyl value (2.5.3.) .............................................................. 127
Human coagulation factor VIII............................................. 1736 Hydroxypropylbetadex............................................................ 1771
Human coagulation factor VIII, assay of (2.7.4.)................. 194 Hydroxypropylbetadexum .................................................... 1771
Human coagulation factor VIII (rDNA)............................... 1737 Hydroxypropylcellulose .......................................................... 1773
Human coagulation factor X, assay of (2.7.19.) ....................210 Hydroxypropylcellulosum .................................................... 1773
Human coagulation factor XI................................................ 1739 Hydroxypropylmethylcellulose.............................................. 1780
Human coagulation factor XI, assay of (2.7.22.) ................. 212 Hydroxypropylmethylcellulose phthalate........................... 1781
Human fibrinogen.................................................................... 1740 Hydroxyzine hydrochloride ................................................... 1774
Human hepatitis A immunoglobulin ....................................1741 Hydroxyzini hydrochloridum .............................................. 1774
Human hepatitis B immunoglobulin ....................................1741 Hymecromone........................................................................... 1775
Human hepatitis B immunoglobulin for intravenous Hymecromonum...................................................................... 1775
administration .........................................................................1741 Hyoscine butylbromide ........................................................... 1776
Human insulin .......................................................................... 1800 Hyoscine hydrobromide.......................................................... 1777
Human measles immunoglobulin......................................... 1742 Hyoscini butylbromidum ...................................................... 1776
Human normal immunoglobulin.......................................... 1742 Hyoscini hydrobromidum..................................................... 1777
Human normal immunoglobulin for intravenous Hyoscyamine sulphate ............................................................ 1778
administration ........................................................................ 1744 Hyoscyamini sulfas ................................................................ 1778
Human plasma for fractionation........................................... 1746 Hyperici herba .........................................................................2485
Human plasma (pooled and treated for virus Hypericum .................................................................................2485
inactivation) ............................................................................ 1747 Hypericum for homoeopathic preparations ......................... 898
Human prothrombin complex............................................... 1748 Hypericum perforatum
Human rabies immunoglobulin............................................ 1750 ad praeparationes homoeopathicas................................... 898
Human rubella immunoglobulin .......................................... 1751 Hypromellose ............................................................................ 1780
Human tetanus immunoglobulin ......................................... 1751 Hypromellose phthalate ......................................................... 1781
Human varicella immunoglobulin........................................ 1752 Hypromellosi phthalas........................................................... 1781
Human varicella immunoglobulin for intravenous Hypromellosum ....................................................................... 1780
administration ........................................................................ 1753
Human von Willebrand factor, assay of (2.7.21.) .................211 I
Hyaluronidase .......................................................................... 1753 Ibuprofen ................................................................................... 1785
Hyaluronidasum ..................................................................... 1753 Ibuprofenum............................................................................. 1785
Hydralazine hydrochloride .................................................... 1754 Iceland moss.............................................................................. 1787
Hydralazini hydrochloridum ............................................... 1754 ICH (5.8.)...................................................................................... 551
Hydrargyri dichloridum ........................................................ 1995 Ichthammol ............................................................................... 1787
Hydrastis rhizoma .................................................................. 1683 Ichthammolum ........................................................................ 1787
Hydrochloric acid, concentrated........................................... 1755 Identification (2.3.) ...................................................................... 95
Hydrochloric acid, dilute ........................................................ 1756 Identification and control of residual solvents (2.4.24.).... 113
Hydrochlorothiazide................................................................ 1756 Identification of fatty oils by thin-layer chromatography
Hydrochlorothiazidum .......................................................... 1756 (2.3.2.) .......................................................................................... 98
Hydrocortisone......................................................................... 1757 Identification of phenothiazines by thin-layer
Hydrocortisone acetate........................................................... 1759 chromatography (2.3.3.) ........................................................... 99
Hydrocortisone hydrogen succinate.....................................1761 Identification reactions of ions and functional groups
Hydrocortisoni acetas............................................................ 1759 (2.3.1.)........................................................................................... 95
Hydrocortisoni hydrogenosuccinas ....................................1761 Idoxuridine ................................................................................ 1788
Hydrocortisonum .................................................................... 1757 Idoxuridinum ........................................................................... 1788

General Notices (1) apply to all monographs and other texts 3065
Index EUROPEAN PHARMACOPOEIA 5.1

Iecoris aselli oleum A.............................................................1348 Immunoserum contra venena viperarum


Iecoris aselli oleum B ............................................................1352 europaearum ........................................................................... 806
Ifosfamide .................................................................................. 1789 Immunoserum diphthericum ................................................ 801
Ifosfamidum ............................................................................. 1789 Immunoserum gangraenicum (Clostridium novyi) ........ 802
Imipenem ................................................................................... 1791 Immunoserum gangraenicum
Imipenemum............................................................................ 1791 (Clostridium perfringens)..................................................... 803
Imipramine hydrochloride ..................................................... 1792 Immunoserum gangraenicum (Clostridium septicum).. 804
Imipramini hydrochloridum................................................ 1792 Immunoserum gangraenicum mixtum............................... 802
Immunochemical methods (2.7.1.) ......................................... 187 Immunoserum tetanicum ad usum humanum................. 805
Immunoglobulin, animal, anti-T lymphocyte, for human Immunoserum tetanicum ad usum veterinarium...5.1-2868
use............................................................................................. 1010 Implants ..............................................................................5.1-2843
Immunoglobulin for intravenous administration, human Impurities in substances for pharmaceutical use, control of
hepatitis B ................................................................................1741 (5.10.).......................................................................................... 559
Immunoglobulin for intravenous administration, human Indapamide................................................................................ 1793
normal ...................................................................................... 1744 Indapamidum .......................................................................... 1793
Immunoglobulin for intravenous administration, human Indicators, relationship between approximate pH and colour
varicella.................................................................................... 1753 (2.2.4.) .......................................................................................... 27
Immunoglobulin, human anti-D ........................................... 1732 Indii (111In) chloridi solutio .................................................... 828
Immunoglobulin, human anti-D, assay of (2.7.13.)............. 205 Indii (111In) oxini solutio ......................................................... 829
Immunoglobulin, human anti-D, for intravenous Indii (111In) pentetatis solutio iniectabilis .......................... 830
administration ........................................................................ 1733 Indium (111In) chloride solution .............................................. 828
Immunoglobulin, human hepatitis A....................................1741 Indium (111In) oxine solution ................................................... 829
Immunoglobulin, human hepatitis B ...................................1741 Indium (111In) pentetate injection........................................... 830
Immunoglobulin, human measles ........................................ 1742 Indometacin .............................................................................. 1794
Immunoglobulin, human normal ......................................... 1742 Indometacinum ....................................................................... 1794
Immunoglobulin, human rabies ........................................... 1750 Infectious bovine rhinotracheitis vaccine (live),
Immunoglobulin, human rubella ......................................... 1751 freeze-dried................................................................................ 768
Immunoglobulin, human tetanus......................................... 1751 Infectious bronchitis vaccine (inactivated), avian ............... 718
Immunoglobulin, human varicella ....................................... 1752 Infectious bronchitis vaccine (live), avian............................. 720
Immunoglobulin, test for anticomplementary activity of Infectious bursal disease vaccine (inactivated), avian........ 722
(2.6.17.)....................................................................................... 170 Infectious bursal disease vaccine (live), avian ..................... 723
Immunoglobulin, test for Fc function of (2.7.9.)................. 202 Infectious chicken anaemia vaccine (live) ............................ 769
Immunoglobulinum anti-T lymphocytorum ex animale ad Infectious encephalomyelitis vaccine (live), avian .............. 725
usum humanum.................................................................... 1010 Infectious laryngotracheitis vaccine (live), avian ................ 727
Immunoglobulinum humanum anti-D.............................. 1732 Influenza vaccine (split virion, inactivated) ......................... 671
Immunoglobulinum humanum anti-D ad usum Influenza vaccine (surface antigen, inactivated)................. 673
intravenosum ......................................................................... 1733 Influenza vaccine (surface antigen, inactivated,
Immunoglobulinum humanum hepatitidis A ..................1741 virosome) ................................................................................... 674
Immunoglobulinum humanum hepatitidis B ..................1741 Influenza vaccine (whole virion, inactivated) ...................... 676
Immunoglobulinum humanum hepatitidis B ad usum Infrared absorption spectrophotometry (2.2.24.) ................. 37
intravenosum ..........................................................................1741 Infusions .............................................................................5.1-2842
Immunoglobulinum humanum morbillicum .................. 1742 Inhalanda...........................................................................5.1-2843
Immunoglobulinum humanum normale ......................... 1742 Inhalation gas, krypton (81MKr) ............................................... 833
Immunoglobulinum humanum normale ad usum Inhalation, preparations for............................................5.1-2843
intravenosum ......................................................................... 1744 Inhalation, preparations for : aerodynamic assessment of fine
Immunoglobulinum humanum rabicum.......................... 1750 particles (2.9.18.) ............................................................5.1-2799
Immunoglobulinum humanum rubellae.......................... 1751 Injections ............................................................................5.1-2841
Immunoglobulinum humanum tetanicum ...................... 1751 Injections, gels for.............................................................5.1-2843
Immunoglobulinum humanum varicellae....................... 1752 Injections or infusions, concentrates for .....................5.1-2842
Immunoglobulinum humanum varicellae ad usum Injections or infusions, powders for .............................5.1-2842
intravenosum ......................................................................... 1753 Inserts, ophthalmic.................................................................... 604
Immunosera ad usum veterinarium.................................... 575 Insulin aspart ............................................................................ 1795
Immunosera and vaccines, phenol in (2.5.15.) .....................131 Insulin, bovine .......................................................................... 1797
Immunosera and vaccines, veterinary, evaluation of safety Insulin, human.......................................................................... 1800
(5.2.6.) ...............................................................................5.1-2827 Insulini biphasici iniectabilium.......................................... 1802
Immunosera and vaccines, veterinary, evaluation of the Insulini isophani biphasici iniectabilium ........................ 1803
efficacy (5.2.7) .................................................................5.1-2829 Insulini isophani iniectabilium .......................................... 1803
Immunosera and vaccines, veterinary, evaluation of the Insulin injection, biphasic ...................................................... 1802
safety of each batch (5.2.9.)..........................................5.1-2830 Insulin injection, biphasic isophane .................................... 1803
Immunosera ex animale ad usum humanum ................... 573 Insulin injection, isophane..................................................... 1803
Immunosera for human use, animal...................................... 573 Insulin injection, soluble ........................................................ 1803
Immunosera for veterinary use ............................................. 575 Insulini solubilis iniectabilium ........................................... 1803
Immunoserum botulinicum ................................................... 801 Insulini zinci amorphi suspensio iniectabilis................. 1811
Immunoserum clostridii novyi alpha ad usum Insulini zinci cristallini suspensio iniectabilis............... 1812
veterinarium ...................................................................5.1-2865 Insulini zinci suspensio iniectabilis .................................. 1811
Immunoserum clostridii perfringentis beta ad usum Insulin lispro ............................................................................. 1804
veterinarium ...................................................................5.1-2866 Insulin, porcine......................................................................... 1806
Immunoserum clostridii perfringentis epsilon ad usum Insulin preparations, injectable ........................................... 1808
veterinarium ...................................................................5.1-2867 Insulinum aspartum .............................................................. 1795

3066 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Insulinum bovinum................................................................ 1797 Isoniazid..................................................................................... 1839


Insulinum humanum............................................................. 1800 Isoniazidum ............................................................................. 1839
Insulinum lisprum.................................................................. 1804 Isophane insulin injection...................................................... 1803
Insulinum porcinum.............................................................. 1806 Isoprenaline hydrochloride.................................................... 1839
Insulin zinc injectable suspension ....................................... 1811 Isoprenaline sulphate.............................................................. 1840
Insulin zinc injectable suspension (amorphous) .............. 1811 Isoprenalini hydrochloridum .............................................. 1839
Insulin zinc injectable suspension (crystalline) ................ 1812 Isoprenalini sulfas .................................................................. 1840
Interferon alfa-2 concentrated solution .............................. 1812 Isopropyl alcohol...................................................................... 1841
Interferon gamma-1b concentrated solution ..................... 1815 Isopropylis myristas ........................................................5.1-2952
Interferoni alfa-2 solutio concentrata................................ 1812 Isopropylis palmitas........................................................5.1-2953
Interferoni gamma-1b solutio concentrata ...................... 1815 Isopropyl myristate...........................................................5.1-2952
Interferons, assay of (5.6.)........................................................ 533 Isopropyl palmitate...........................................................5.1-2953
int-rac-α-Tocopherolum ..................................................5.1-3023 Isosorbide dinitrate, diluted ................................................. 1844
int-rac-α-Tocopherylis acetas ........................................5.1-3024 Isosorbide mononitrate, diluted .......................................... 1845
Intramammary preparations for veterinary use.................. 606 Isosorbidi dinitras dilutus..................................................... 1844
Intraruminal devices ................................................................. 607 Isosorbidi mononitras dilutus ............................................. 1845
In vivo assay of poliomyelitis vaccine (inactivated) Isotretinoin ................................................................................ 1847
(2.7.20.) .......................................................................................210 Isotretinoinum ......................................................................... 1847
Iobenguane (123I) injection....................................................... 831 Isoxsuprine hydrochloride ..................................................... 1848
Iobenguane (131I) injection for diagnostic use ..................... 832 Isoxsuprini hydrochloridum ................................................ 1848
Iobenguane (131I) injection for therapeutic use................... 833 Ispaghula husk ......................................................................... 1849
Iobenguani (123I) solutio iniectabilis.................................... 831 Ispaghula seed .......................................................................... 1850
Iobenguani (131I) solutio iniectabilis ad usum Isradipine ................................................................................... 1851
diagnosticum ........................................................................... 832 Isradipinum .............................................................................. 1851
Iobenguani (131I) solutio iniectabilis ad usum Itraconazole .............................................................................. 1852
therapeuticum.......................................................................... 833 Itraconazolum.......................................................................... 1852
Iodinated (125I) human albumin injection ............................. 827 Iuniperi aetheroleum............................................................. 1863
Iodinated povidone.................................................................. 2291 Iuniperi pseudo-fructus......................................................... 1862
Iodinati (125I) humani albumini solutio iniectabilis ........ 827 Ivermectin.................................................................................. 1854
Iodine.......................................................................................... 1819 Ivermectinum........................................................................... 1854
Iodine value (2.5.4.) ................................................................... 127 Ivy leaf .................................................................................5.1-2954
Iodum ......................................................................................... 1819
Iohexol........................................................................................ 1819 J
Iohexolum ................................................................................. 1819 Javanese turmeric ....................................................................2645
Ionic concentration, potentiometric determination of using Java tea ....................................................................................... 1859
ion-selective electrodes (2.2.36.)............................................. 55 Josamycin................................................................................... 1860
Ions and functional groups, identification reactions Josamycini propionas............................................................ 1861
(2.3.1.)........................................................................................... 95 Josamycin propionate.............................................................. 1861
Ion-selective electrodes, potentiometric determination of Josamycinum ........................................................................... 1860
ionic concentration (2.2.36.) ................................................... 55 Juniper........................................................................................ 1862
Iopamidol................................................................................... 1822 Juniper oil .................................................................................. 1863
Iopamidolum............................................................................ 1822
Iopanoic acid............................................................................. 1824
K
Iotalamic acid............................................................................ 1825
Ioxaglic acid .............................................................................. 1826 Kalii acetas ...............................................................................2273
Ipecacuanhae extractum fluidum normatum ..........5.1-2951 Kalii bromidum........................................................................2273
Ipecacuanhae pulvis normatus........................................... 1829 Kalii carbonas.......................................................................... 2274
Ipecacuanhae radix................................................................ 1829 Kalii chloridum........................................................................2275
Ipecacuanhae tinctura normata ..................................5.1-2951 Kalii citras.................................................................................2275
Ipecacuanha liquid extract, standardised ....................5.1-2951 Kalii clavulanas....................................................................... 2276
Ipecacuanha, prepared............................................................ 1829 Kalii clavulanas dilutus.........................................................2278
Ipecacuanha root ..................................................................... 1829 Kalii dihydrogenophosphas .................................................2280
Ipecacuanha tincture, standardised..............................5.1-2951 Kalii hydrogenoaspartas hemihydricus............................2280
Ipratropii bromidum .............................................................. 1831 Kalii hydrogenocarbonas...................................................... 2281
Ipratropium bromide............................................................... 1831 Kalii hydrogenotartras...........................................................2282
Iron (2.4.9.).................................................................................. 107 Kalii hydroxidum ....................................................................2283
Iron for homoeopathic preparations ..................................... 899 Kalii iodidum ...........................................................................2283
Irrigation, preparations for ...................................................... 622 Kalii metabisulfis ....................................................................2284
Isoconazole................................................................................ 1833 Kalii natrii tartras tetrahydricus.........................................2286
Isoconazole nitrate .................................................................. 1834 Kalii nitras ................................................................................2284
Isoconazoli nitras ................................................................... 1834 Kalii perchloras .......................................................................2285
Isoconazolum........................................................................... 1833 Kalii permanganas .................................................................2286
Isoelectric focusing (2.2.54.).......................................................81 Kalii sorbas ...............................................................................2287
Isoflurane................................................................................... 1835 Kalii sulfas ................................................................................2288
Isofluranum.............................................................................. 1835 Kanamycin acid sulphate ....................................................... 1867
Isoleucine................................................................................... 1836 Kanamycini monosulfas ....................................................... 1868
Isoleucinum.............................................................................. 1836 Kanamycini sulfas acidus..................................................... 1867
Isomalt........................................................................................ 1837 Kanamycin monosulphate...................................................... 1868
Isomaltum ................................................................................. 1837 Kaolin, heavy............................................................................. 1869

General Notices (1) apply to all monographs and other texts 3067
Index EUROPEAN PHARMACOPOEIA 5.1

Kaolinum ponderosum.......................................................... 1869 Levonorgestrel.......................................................................... 1911


Kelp ............................................................................................. 1869 Levonorgestrelum ................................................................... 1911
Ketamine hydrochloride......................................................... 1870 Levothyroxine sodium ............................................................ 1912
Ketamini hydrochloridum .................................................... 1870 Levothyroxinum natricum ................................................... 1912
Ketobemidone hydrochloride................................................ 1871 Lichen islandicus.................................................................... 1787
Ketoconazole ............................................................................ 1872 Lidocaine ................................................................................... 1913
Ketoconazolum........................................................................ 1872 Lidocaine hydrochloride......................................................... 1914
Ketoprofen................................................................................. 1874 Lidocaini hydrochloridum ................................................... 1914
Ketoprofenum .......................................................................... 1874 Lidocainum .............................................................................. 1913
Ketotifen hydrogen fumarate ................................................ 1875 Light liquid paraffin ................................................................ 2186
Ketotifeni hydrogenofumaras .............................................. 1875 Light magnesium carbonate.................................................. 1954
Knotgrass................................................................................... 1877 Light magnesium oxide .......................................................... 1958
Krypton (81mKr) inhalation gas................................................ 833 Lime flower ............................................................................... 1914
Kryptonum (81mKr) ad inhalationem .................................. 833 Limit test of particle size by microscopy (2.9.13.) .............. 239
Limit tests (2.4.).......................................................................... 103
L Limit tests, standard solutions for (4.1.2.)............................ 426
Labetalol hydrochloride ......................................................... 1881 Limit tests, standard solutions for (4.1.2.)...................5.1-2818
Labetaloli hydrochloridum................................................... 1881 Limonis aetheroleum............................................................. 1895
Lacca ..........................................................................................2409 Lincomycin hydrochloride ..................................................... 1915
Lactic acid.................................................................................. 1882 Lincomycini hydrochloridum.............................................. 1915
Lactic acid, (S)- ......................................................................... 1883 Lindane ...................................................................................... 1916
Lactitol monohydrate.............................................................. 1883 Lindanum ................................................................................. 1916
Lactitolum monohydricum................................................... 1883 Linen thread, sterile, in distributor for veterinary use ..... 886
Lactobionic acid ....................................................................... 1885 Lini oleum virginale .............................................................. 1918
Lactose, anhydrous.................................................................. 1886 Lini semen .........................................................................5.1-2960
Lactose monohydrate.............................................................. 1887 Linoleoyl macrogolglycerides.................................................1917
Lactosum anhydricum........................................................... 1886 Linseed ................................................................................5.1-2960
Lactosum monohydricum..................................................... 1887 Linseed oil, virgin .................................................................... 1918
Lactulose.................................................................................... 1888 Liothyronine sodium............................................................... 1919
Lactulose, liquid ....................................................................... 1890 Liothyroninum natricum ..................................................... 1919
Lactulosum ............................................................................... 1888 Liquid and semi-solid preparations, test for deliverable mass
Lactulosum liquidum............................................................. 1890 or volume (2.9.28.) .................................................................. 263
Lanugo cellulosi absorbens.................................................. 2681 Liquid chromatography (2.2.29.).............................................. 43
Lanugo gossypii absorbens ..................................................1369 Liquid extracts............................................................................ 571
Lauroyl macrogolglycerides .................................................. 1892 Liquid glucose .......................................................................... 1667
Lavandulae aetheroleum ...................................................... 1894 Liquid glucose, spray-dried.................................................... 1668
Lavandulae flos ....................................................................... 1893 Liquid lactulose ........................................................................ 1890
Lavender flower........................................................................ 1893 Liquid maltitol .......................................................................... 1969
Lavender oil............................................................................... 1894 Liquid paraffin .......................................................................... 2187
Lead in sugars (2.4.10.) ............................................................ 107 Liquid preparations for cutaneous application ................... 607
Lemon oil................................................................................... 1895 Liquid preparations for cutaneous application,
Leonuri cardiacae herba.......................................................2063 veterinary .................................................................................. 630
Leptospirosis vaccine (inactivated), bovine.......................... 730 Liquid preparations for inhalation ................................5.1-2843
Leptospirosis vaccine (inactivated), canine .......................... 740 Liquid preparations for oral use............................................. 608
Leucine....................................................................................... 1897 Liquid sorbitol (crystallising) ................................................2471
Leucinum .................................................................................. 1897 Liquid sorbitol (non-crystallising) ........................................2472
Leuprorelin................................................................................ 1898 Liquid sorbitol, partially dehydrated ...................................2473
Leuprorelinum......................................................................... 1898 Liquiritiae extractum fluidum
Levamisole for veterinary use ............................................... 1899 ethanolicum normatum ...................................................... 1920
Levamisole hydrochloride...................................................... 1900 Liquiritiae radix ...................................................................... 1921
Levamisoli hydrochloridum................................................. 1900 Liquorice ethanolic liquid extract, standardised .............. 1920
Levamisolum ad usum veterinarium ................................ 1899 Liquorice root ........................................................................... 1921
Levistici radix........................................................................... 1932 Lisinopril dihydrate ................................................................. 1922
Levocabastine hydrochloride ................................................ 1902 Lisinoprilum dihydricum ..................................................... 1922
Levocabastini hydrochloridum ........................................... 1902 Lithii carbonas......................................................................... 1923
Levocarnitine .....................................................................5.1-2959 Lithii citras ............................................................................... 1924
Levocarnitinum................................................................5.1-2959 Lithium carbonate ................................................................... 1923
Levodopa.................................................................................... 1904 Lithium citrate.......................................................................... 1924
Levodopum ............................................................................... 1904 L-Methionine ([11C]methyl) injection...................................... 834
Levodropropizine ..................................................................... 1905 L-Methionini ([11C]methyl) solutio iniectabilis .................. 834
Levodropropizinum................................................................ 1905 Lobeline hydrochloride........................................................... 1925
Levomenthol ............................................................................. 1907 Lobelini hydrochloridum...................................................... 1925
Levomentholum....................................................................... 1907 Lomustine.................................................................................. 1926
Levomepromazine hydrochloride......................................... 1908 Lomustinum ............................................................................. 1926
Levomepromazine maleate .................................................... 1908 Loosestrife ................................................................................. 1927
Levomepromazini hydrochloridum ................................... 1908 Loperamide hydrochloride..................................................... 1928
Levomepromazini maleas .................................................... 1908 Loperamide oxide monohydrate........................................... 1930
Levomethadone hydrochloride ............................................. 1909 Loperamidi hydrochloridum................................................ 1928
Levomethadoni hydrochloridum ........................................ 1909 Loperamidi oxidum monohydricum.................................. 1930

3068 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Lorazepam................................................................................. 1931 Magnesium (2.4.6.) .................................................................... 104


Lorazepamum.......................................................................... 1931 Magnesium acetate tetrahydrate .......................................... 1952
Loss on drying (2.2.32.).............................................................. 50 Magnesium and alkaline-earth metals (2.4.7.) ..................... 104
Loss on drying of extracts (2.8.17.)........................................ 222 Magnesium aspartate dihydrate ........................................... 1953
Lovage root................................................................................ 1932 Magnesium carbonate, heavy ................................................ 1954
Lovastatin .................................................................................. 1933 Magnesium carbonate, light .................................................. 1954
Lovastatinum ........................................................................... 1933 Magnesium chloride 4.5-hydrate .......................................... 1955
Low-molecular-mass heparins ................................................1717 Magnesium chloride hexahydrate ........................................ 1956
Lozenges and pastilles.............................................................. 613 Magnesium glycerophosphate ............................................. 1957
Lozenges, compressed .............................................................. 613 Magnesium hydroxide............................................................. 1957
Lubricant, silicone oil (3.1.8.).................................................. 287 Magnesium oxide, heavy......................................................... 1958
Lupuli flos................................................................................. 1730 Magnesium oxide, light........................................................... 1958
Lynestrenol................................................................................ 1935 Magnesium peroxide ............................................................... 1959
Lynestrenolum......................................................................... 1935 Magnesium pidolate ................................................................ 1960
Lysine acetate ....................................................................5.1-2960 Magnesium stearate................................................................. 1961
Lysine hydrochloride............................................................... 1936 Magnesium sulphate heptahydrate...................................... 1962
Lysini acetas......................................................................5.1-2960 Magnesium trisilicate .............................................................. 1963
Lysini hydrochloridum.......................................................... 1936 Maize oil, refined...................................................................... 1964
Lythri herba.............................................................................. 1927 Maize starch .......................................................................5.1-2965
Malathion................................................................................... 1965
M Malathionum ............................................................................ 1965
Macrogol 15 hydroxystearate ................................................ 1941 Maleic acid................................................................................. 1966
Macrogol 20 glyceroli monostearas ................................... 1942 Malic acid ................................................................................... 1966
Macrogol 20 glycerol monostearate .................................... 1942 Mallow flower............................................................................ 1967
Macrogol 6 glycerol caprylocaprate..................................... 1941 Maltitol ....................................................................................... 1968
Macrogol 6 glyceroli caprylocapras................................... 1941 Maltitol, liquid........................................................................... 1969
Macrogola.................................................................................. 1950 Maltitolum................................................................................. 1968
Macrogol cetostearyl ether .................................................... 1943 Maltitolum liquidum............................................................... 1969
Macrogolglyceridorum caprylocaprates ........................... 1173 Maltodextrin.............................................................................. 1970
Macrogolglyceridorum laurates .......................................... 1892 Maltodextrinum ....................................................................... 1970
Macrogolglyceridorum linoleates........................................1917 Malvae sylvestris flos ............................................................. 1967
Macrogolglyceridorum oleates ............................................ 2133 Manganese sulphate monohydrate ...................................... 1971
Macrogolglyceridorum stearates......................................... 2491 Mangani sulfas monohydricus ............................................ 1971
Macrogolglycerol cocoates..................................................... 1947 Mannheimia vaccine (inactivated) for cattle ........................ 771
Macrogolglycerol hydroxystearate ....................................... 1948 Mannheimia vaccine (inactivated) for sheep........................ 772
Macrogolglyceroli cocoates .................................................. 1947 Mannitol ..................................................................................... 1971
Macrogolglyceroli hydroxystearas...................................... 1948 Mannitolum .............................................................................. 1971
Macrogolglyceroli ricinoleas................................................ 1949 Maprotiline hydrochloride ..................................................... 1973
Macrogolglycerol ricinoleate ................................................. 1949 Maprotilini hydrochloridum ................................................ 1973
Macrogoli 15 hydroxystearas ............................................... 1941 Marek’s disease vaccine (live).................................................. 774
Macrogoli aether cetostearylicus ........................................ 1943 Marrubii herba..................................................................5.1-3039
Macrogoli aether laurilicum ................................................ 1944 Marshmallow leaf ..................................................................... 1974
Macrogoli aether oleicum ..................................................... 1945 Marshmallow root .................................................................... 1975
Macrogoli aether stearylicus................................................ 1946 Mass spectrometry (2.2.43.)....................................................... 65
Macrogoli oleas........................................................................ 1944 Mass uniformity of delivered doses from multidose containers
Macrogoli stearas .................................................................... 1946 (2.9.27.) ...................................................................................... 263
Macrogol lauryl ether ............................................................. 1944 Mass uniformity of single-dose preparations (2.9.5.) ......... 233
Macrogol oleate ........................................................................ 1944 Mastic.......................................................................................... 1975
Macrogol oleyl ether ............................................................... 1945 Masticabilia gummis medicata.............................................. 601
Macrogols................................................................................... 1950 Mastix ......................................................................................... 1975
Macrogol stearate..................................................................... 1946 Materials based on non-plasticised poly(vinyl chloride) for
Macrogol stearyl ether............................................................ 1946 containers for dry dosage forms for oral administration
Magaldrate................................................................................. 1951 (3.1.11.)....................................................................................... 291
Magaldratum ............................................................................ 1951 Materials based on non-plasticised poly(vinyl chloride)
Magnesii acetas tetrahydricus ............................................. 1952 for containers for non-injectable, aqueous solutions
Magnesii aspartas dihydricus.............................................. 1953 (3.1.10.) ...................................................................................... 289
Magnesii chloridum 4.5-hydricum ..................................... 1955 Materials based on plasticised poly(vinyl chloride) for
Magnesii chloridum hexahydricum ................................... 1956 containers for aqueous solutions for intravenous infusion
Magnesii glycerophosphas ................................................... 1957 (3.1.14.) ...................................................................................... 296
Magnesii hydroxidum ............................................................ 1957 Materials based on plasticised poly(vinyl chloride) for
Magnesii oxidum leve ............................................................ 1958 containers for human blood and blood components
Magnesii oxidum ponderosum............................................ 1958 (3.1.1.1.) ..................................................................................... 269
Magnesii peroxidum............................................................... 1959 Materials based on plasticised poly(vinyl chloride) for
Magnesii pidolas ..................................................................... 1960 tubing used in sets for the transfusion of blood and blood
Magnesii stearas...................................................................... 1961 components (3.1.1.2.).............................................................. 272
Magnesii subcarbonas levis.................................................. 1954 Materials for containers for human blood and blood
Magnesii subcarbonas ponderosus .................................... 1954 components (3.1.1.) ................................................................. 269
Magnesii sulfas heptahydricus ............................................ 1962 Materials used for the manufacture of containers (3.1.) ... 269
Magnesii trisilicas................................................................... 1963 Matricariae aetheroleum................................................5.1-2967

General Notices (1) apply to all monographs and other texts 3069
Index EUROPEAN PHARMACOPOEIA 5.1

Matricariae extractum fluidum ....................................5.1-2966 Mesterolonum .......................................................................... 1999


Matricariae flos ................................................................5.1-2965 Mestranol ...................................................................................2000
Matricaria flower ...............................................................5.1-2965 Mestranolum.............................................................................2000
Matricaria liquid extract ..................................................5.1-2966 Metacresol ................................................................................. 2001
Matricaria oil......................................................................5.1-2967 Metacresolum ........................................................................... 2001
Maydis amylum ................................................................5.1-2965 Metamizole sodium .................................................................2002
Maydis oleum raffinatum...................................................... 1964 Metamizolum natricum.........................................................2002
Meadowsweet ............................................................................ 1980 Metformin hydrochloride .......................................................2003
Measles immunoglobulin, human ........................................ 1742 Metformini hydrochloridum ................................................2003
Measles, mumps and rubella vaccine (live) .......................... 678 Methacrylic acid - ethyl acrylate copolymer (1:1) .............2005
Measles vaccine (live) ................................................................ 679 Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion
Measurement of consistency by penetrometry (2.9.9.) ...... 235 30 per cent ..............................................................................2005
Mebendazole ............................................................................. 1981 Methacrylic acid - methyl methacrylate copolymer (1:1) ..2006
Mebendazolum......................................................................... 1981 Methacrylic acid - methyl methacrylate copolymer (1:2) ..2007
Meclozine hydrochloride........................................................ 1982 Methadone hydrochloride......................................................2007
Meclozini hydrochloridum ................................................... 1982 Methadoni hydrochloridum .................................................2007
Medicated chewing gum, drug release from (2.9.25.)........ 260 Methanol and 2-propanol, test for (2.9.11.) .......................... 239
Medicated chewing gums ......................................................... 601 Methaqualone ...........................................................................2008
Medicated feeding stuffs for veterinary use, premixes for ..617 Methaqualonum ......................................................................2008
Medicated foams......................................................................... 604 Methenamine ............................................................................2009
Medicated plasters ..................................................................... 626 Methenaminum .......................................................................2009
Medicated tampons.................................................................... 628 Methionine ................................................................................ 2010
Medicated vaginal tampons ..................................................... 630 Methionine ([11C]methyl) injection, L-.................................... 834
Medicinal air................................................................................ 929 Methionine, DL-......................................................................... 2010
Medicinal air, synthetic............................................................. 932 Methioninum............................................................................ 2010
Medium-chain triglycerides....................................................2623 Methods in pharmacognosy (2.8.) .......................................... 215
Medroxyprogesterone acetate ............................................... 1983 Methods of preparation of sterile products (5.1.1.)............ 445
Medroxyprogesteroni acetas ................................................ 1983 Methotrexate ............................................................................. 2011
Mefenamic acid ......................................................................... 1984 Methotrexatum......................................................................... 2011
Mefloquine hydrochloride...................................................... 1986 Methylatropine bromide ......................................................... 2014
Mefloquini hydrochloridum................................................. 1986 Methylatropine nitrate ............................................................ 2015
Megestrol acetate ..................................................................... 1987 Methylatropini bromidum..................................................... 2014
Megestroli acetas ..................................................................... 1987 Methylatropini nitras ............................................................. 2015
Meglumine................................................................................. 1988 Methylcellulose......................................................................... 2016
Megluminum ............................................................................ 1988 Methylcellulosum .................................................................... 2016
Mel........................................................................................5.1-2946 Methyldopa................................................................................ 2016
Melaleucae aetheroleum .......................................................2534 Methyldopum ........................................................................... 2016
Melilot..................................................................................5.1-2970 Methylene blue .........................................................................2028
Meliloti herba ....................................................................5.1-2970 Methylene chloride .................................................................. 2017
Melissae folium........................................................................ 1989 Methyleni chloridum.............................................................. 2017
Melissa leaf ................................................................................ 1989 Methylhydroxyethylcellulose................................................. 2018
Melting point - capillary method (2.2.14.)............................... 32 Methylhydroxyethylcellulosum............................................ 2018
Melting point - instantaneous method (2.2.16.) .................... 33 Methylis nicotinas............................................................5.1-2972
Melting point - open capillary method (2.2.15.) .................... 33 Methylis parahydroxybenzoas ............................................. 2013
Menadione ................................................................................. 1990 Methylis parahydroxybenzoas natricum .......................... 2441
Menadionum ............................................................................ 1990 Methylis salicylas .................................................................... 2014
Meningococcal group C conjugate vaccine.......................... 680 Methyl nicotinate ..............................................................5.1-2972
Meningococcal polysaccharide vaccine................................. 682 Methyl parahydroxybenzoate ................................................ 2013
Menthae arvensis aetheroleum partim mentholi Methylpentoses in polysaccharide vaccines (2.5.21.) ......... 133
privum .....................................................................................2050 Methylphenobarbital ............................................................... 2019
Menthae piperitae aetheroleum ..........................................2206 Methylphenobarbitalum ........................................................ 2019
Menthae piperitae folium .....................................................2205 Methylprednisolone.................................................................2020
Menthol, racemic...................................................................... 1991 Methylprednisolone acetate...................................................2022
Mentholum racemicum ......................................................... 1991 Methylprednisolone hydrogen succinate ............................2024
Menyanthidis trifoliatae folium .......................................... 1115 Methylprednisoloni acetas....................................................2022
Mepivacaine hydrochloride.................................................... 1992 Methylprednisoloni hydrogenosuccinas...........................2024
Mepivacaini hydrochloridum .............................................. 1992 Methylprednisolonum............................................................2020
Meprobamate ............................................................................ 1993 Methylpyrrolidone, N- .............................................................2026
Meprobamatum........................................................................ 1993 Methylrosanilinii chloridum .........................................5.1-2973
Mepyramine maleate ............................................................... 1994 Methylrosanilinium chloride ..........................................5.1-2973
Mepyramini maleas................................................................ 1994 Methyl salicylate....................................................................... 2014
Mercaptopurine ........................................................................ 1995 Methyltestosterone ..................................................................2027
Mercaptopurinum ................................................................... 1995 Methyltestosteronum ..............................................................2027
Mercuric chloride..................................................................... 1995 Methylthioninii chloridum ...................................................2028
Mesalazine ................................................................................. 1996 Methylthioninium chloride ....................................................2028
Mesalazinum ............................................................................ 1996 Metixene hydrochloride..........................................................2029
Mesna...................................................................................5.1-2971 Metixeni hydrochloridum .....................................................2029
Mesnum ..............................................................................5.1-2971 Metoclopramide........................................................................2030
Mesterolone............................................................................... 1999 Metoclopramide hydrochloride............................................. 2031

3070 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Metoclopramidi hydrochloridum ........................................ 2031 Multidose containers, uniformity of mass of delivered doses
Metoclopramidum ...................................................................2030 (2.9.27.) ...................................................................................... 263
Metoprololi succinas ..............................................................2032 Mumps vaccine (live) ................................................................. 684
Metoprololi tartras ..................................................................2034 Mupirocin...................................................................................2065
Metoprolol succinate...............................................................2032 Mupirocin calcium ...................................................................2067
Metoprolol tartrate ..................................................................2034 Mupirocinum............................................................................2065
Metrifonate ................................................................................2035 Mupirocinum calcicum .........................................................2067
Metrifonatum............................................................................2035 Musci medicati........................................................................... 604
Metronidazole ...........................................................................2037 Mycobacteria (2.6.2.) ................................................................. 149
Metronidazole benzoate .........................................................2038 Mycoplasmas (2.6.7.).................................................................. 149
Metronidazoli benzoas ..........................................................2038 Myristicae fragrantis aetheroleum ..................................... 2123
Metronidazolum ......................................................................2037 Myrrh ..........................................................................................2069
Mexiletine hydrochloride........................................................2039 Myrrha .......................................................................................2069
Mexiletini hydrochloridum...................................................2039 Myrrhae tinctura .....................................................................2069
Mianserin hydrochloride ........................................................ 2041 Myrrh tincture ..........................................................................2069
Mianserini hydrochloridum ................................................. 2041 Myrtilli fructus recens............................................................ 1099
Miconazole ................................................................................2042 Myrtilli fructus siccus............................................................. 1099
Miconazole nitrate ...................................................................2043 Myxomatosis vaccine (live) for rabbits .................................. 775
Miconazoli nitras ....................................................................2043
Miconazolum............................................................................2042 N
Microbiological assay of antibiotics (2.7.2.).......................... 188 Nabumetone ..............................................................................2073
Microbiological examination of non-sterile products (test for Nabumetonum .........................................................................2073
specified micro-organisms) (2.6.13.) .................................... 156 N-Acetyltryptophan.....................................................................918
Microbiological examination of non-sterile products (total N-Acetyltryptophanum..............................................................918
viable aerobic count) (2.6.12.)............................................... 154 N-Acetyltyrosine ......................................................................... 920
Microbiological quality of pharmaceutical preparations N-Acetyltyrosinum .................................................................... 920
(5.1.4.)......................................................................................... 449 Nadolol ....................................................................................... 2074
Microcrystalline cellulose.......................................................1228 Nadololum................................................................................. 2074
Micro determination of water (2.5.32.).................................. 137 Nadroparin calcium .................................................................2075
Microscopy, limit test of particle size (2.9.13.) .................... 239 Nadroparinum calcicum .......................................................2075
Midazolam .................................................................................2045 Naftidrofuryl hydrogen oxalate.............................................2078
Midazolamum ..........................................................................2045 Naftidrofuryli hydrogenooxalas ..........................................2078
Milk-thistle fruit........................................................................2046 Nalidixic acid.............................................................................2080
Millefolii herba.........................................................................2723 Naloxone hydrochloride dihydrate.......................................2080
Minimising the risk of transmitting animal spongiform Naloxoni hydrochloridum dihydricum .............................2080
encephalopathy agents via human and veterinary medicinal Naltrexone hydrochloride................................................5.1-2979
products (5.2.8.) ....................................................................... 463 Naltrexoni hydrochloridum...........................................5.1-2979
Minocycline hydrochloride.....................................................2047 Naphazoline hydrochloride....................................................2082
Minocyclini hydrochloridum ...............................................2047 Naphazoline nitrate .................................................................2083
Minoxidil .............................................................................5.1-2974 Naphazolini hydrochloridum ..............................................2082
Minoxidilum ......................................................................5.1-2974 Naphazolini nitras ..................................................................2083
Mint oil, partly dementholised ..............................................2050 Naproxen....................................................................................2084
Mitomycin .................................................................................. 2051 Naproxenum.............................................................................2084
Mitomycinum ........................................................................... 2051 Nasal drops and liquid nasal sprays........................................610
Mitoxantrone hydrochloride..................................................2053 Nasalia ..........................................................................................610
Mitoxantroni hydrochloridum.............................................2053 Nasal powders..............................................................................611
Modified-release capsules......................................................... 600 Nasal preparations ......................................................................610
Modified-release granules ........................................................ 606 Nasal preparations, semi-solid..................................................611
Modified-release tablets ............................................................ 628 Nasal sticks...................................................................................611
Molecular mass distribution in dextrans (2.2.39.) ................ 57 Nasal washes ................................................................................611
Molgramostim concentrated solution .................................2054 Natrii acetas trihydricus ....................................................... 2415
Molgramostimi solutio concentrata ...................................2054 Natrii acetatis ([1-11C]) solutio iniectabilis ......................... 839
Mometasone furoate................................................................2057 Natrii alendronas .................................................................... 2416
Mometasoni furoas .................................................................2057 Natrii alginas ........................................................................... 2417
Monographs (1.4.)...........................................................................7 Natrii amidotrizoas ................................................................ 2418
Morantel hydrogen tartrate for veterinary use .................2059 Natrii aminosalicylas dihydricus........................................ 2419
Moranteli hydrogenotartras ad usum veterinarium......2059 Natrii ascorbas.........................................................................2420
Morphine hydrochloride.........................................................2060 Natrii benzoas.......................................................................... 2421
Morphine sulphate................................................................... 2061 Natrii bromidum......................................................................2422
Morphini hydrochloridum....................................................2060 Natrii calcii edetas ..................................................................2422
Morphini sulfas........................................................................ 2061 Natrii caprylas .........................................................................2423
Moss, Iceland ............................................................................ 1787 Natrii carbonas anhydricus...........................................5.1-3008
Mother tinctures for homoeopathic preparations .............. 894 Natrii carbonas decahydricus.......................................5.1-3008
Motherwort ...............................................................................2063 Natrii carbonas monohydricus.....................................5.1-3009
Mouthwashes .............................................................................. 612 Natrii cetylo- et stearylosulfas. ............................................2426
Moxonidine................................................................................2064 Natrii chloridum......................................................................2428
Moxonidinum...........................................................................2064 Natrii chromatis (51Cr) solutio sterilis ................................. 840
Mucoadhesive preparations ..................................................... 613 Natrii citras...............................................................................2429
Mullein flower...........................................................................2065 Natrii cromoglicas ..................................................................2429

General Notices (1) apply to all monographs and other texts 3071
Index EUROPEAN PHARMACOPOEIA 5.1

Natrii cyclamas........................................................................2430 Niclosamidum monohydricum............................................2093


Natrii dihydrogenophosphas dihydricus .......................... 2431 Nicotinamide .............................................................................2094
Natrii docusas .......................................................................... 1471 Nicotinamidum........................................................................2094
Natrii fluoridi (18F) solutio iniectabilis................................ 841 Nicotine ......................................................................................2095
Natrii fluoridum ......................................................................2432 Nicotine resinate ......................................................................2096
Natrii fusidas............................................................................2433 Nicotinic acid ............................................................................2097
Natrii glycerophosphas hydricus ........................................2434 Nicotini resinas .......................................................................2096
Natrii hyaluronas....................................................................2434 Nicotinum .................................................................................2095
Natrii hydrogenocarbonas....................................................2437 Nifedipine...................................................................................2098
Natrii hydroxidum ..................................................................2437 Nifedipinum..............................................................................2098
Natrii iodidi (123I) solutio iniectabilis .................................. 842 Nifuroxazide ..............................................................................2099
Natrii iodidi (131I) capsulae ad usum diagnosticum......... 843 Nifuroxazidum.........................................................................2099
Natrii iodidi (131I) solutio......................................................... 844 Nikethamide .............................................................................. 2100
Natrii iodidi (131I) solutio ad radio-signandum ................. 845 Nimesulide................................................................................. 2101
Natrii iodidum .........................................................................2438 Nimesulidum ............................................................................ 2101
Natrii iodohippurati (123I) solutio iniectabilis ................... 845 Nimodipine ................................................................................ 2102
Natrii iodohippurati (131I) solutio iniectabilis.................... 846 Nimodipinum ........................................................................... 2102
Natrii lactatis solutio..............................................................2438 Nitrazepam ................................................................................ 2103
Natrii laurilsulfas ....................................................................2440 Nitrazepamum ......................................................................... 2103
Natrii metabisulfis .................................................................. 2441 Nitrendipine .............................................................................. 2104
Natrii molybdas dihydricus ..................................................2442 Nitrendipinum ......................................................................... 2104
Natrii nitris ...............................................................................2443 Nitric acid .................................................................................. 2105
Natrii nitroprussias ................................................................2443 Nitric oxide ................................................................................ 2105
Natrii perboras hydricus .......................................................2444 Nitrofural ................................................................................... 2106
Natrii pertechnetatis (99mTc) fissione formati solutio Nitrofuralum............................................................................. 2106
iniectabilis ................................................................................ 847 Nitrofurantoin........................................................................... 2107
Natrii pertechnetatis (99mTc) sine fissione formati solutio Nitrofurantoinum.................................................................... 2107
iniectabilis ................................................................................ 848 Nitrogen ..................................................................................... 2108
Natrii phosphatis (32P) solutio iniectabilis ......................... 849 Nitrogen determination by sulphuric acid digestion
Natrii picosulfas ......................................................................2445 (2.5.9.) ........................................................................................ 129
Natrii polystyrenesulfonas....................................................2446 Nitrogen determination, primary aromatic amino
Natrii propionas ......................................................................2447 (2.5.8.) ........................................................................................ 129
Natrii salicylas .........................................................................2449 Nitrogenii oxidum................................................................... 2105
Natrii selenis pentahydricus ................................................2449 Nitrogenium ............................................................................. 2108
Natrii (S)-lactatis solutio .......................................................2439 Nitrogenium oxygenio depletum ........................................ 2109
Natrii stearas ............................................................................2452 Nitrogen, low-oxygen............................................................... 2109
Natrii stearylis fumaras.........................................................2453 Nitrogen monoxide and nitrogen dioxide in gases
Natrii sulfas anhydricus ........................................................2454 (2.5.26.) ...................................................................................... 135
Natrii sulfas decahydricus ....................................................2455 Nitrous oxide......................................................................5.1-2981
Natrii sulfis anhydricus.........................................................2455 Nitrous oxide in gases (2.5.35.)................................................141
Natrii sulfis heptahydricus ...................................................2456 Nizatidine....................................................................................2111
Natrii thiosulfas ................................................................5.1-3009 Nizatidinum...............................................................................2111
Natrii valproas .........................................................................2457 N-Methylpyrrolidone................................................................2026
Near-infrared spectrophotometry (2.2.40.)............................. 59 N-Methylpyrrolidonum ..........................................................2026
Neohesperidin-dihydrochalcone ...........................................2085 N,N-Dimethylaniline (2.4.26.) ...................................................119
Neohesperidin-dihydrochalconum .....................................2085 Nomegestrol acetate................................................................ 2113
Neomycini sulfas .....................................................................2086 Nomegestroli acetas................................................................ 2113
Neomycin sulphate ..................................................................2086 Nonoxinol 9................................................................................2114
Neonatal piglet colibacillosis vaccine (inactivated) ............ 776 Nonoxinolum 9.........................................................................2114
Neonatal ruminant colibacillosis vaccine (inactivated) ..... 778 Non-sterile products, microbiological examination of (test for
Neostigmine bromide ..............................................................2088 specified micro-organisms) (2.6.13.) .................................... 156
Neostigmine metilsulfate........................................................2089 Non-sterile products, microbiological examination of (total
Neostigmini bromidum..........................................................2088 viable aerobic count) (2.6.12.)............................................... 154
Neostigmini metilsulfas .........................................................2089 Noradrenaline hydrochloride .................................................2114
Netilmicini sulfas ....................................................................2089 Noradrenaline tartrate ............................................................ 2115
Netilmicin sulphate..................................................................2089 Noradrenalini hydrochloridum............................................2114
Nettle leaf............................................................................5.1-2980 Noradrenalini tartras ............................................................. 2115
Neurovirulence test for poliomyelitis vaccine (oral) Norcholesteroli iodinati (131I) solutio iniectabilis ............. 836
(2.6.19.) ...................................................................................... 172 Norcholesterol injection, iodinated (131I) .............................. 836
Neurovirulence test of live viral vaccines (2.6.18.) ............. 172 Norethisterone.......................................................................... 2116
Newcastle disease vaccine (inactivated)................................ 779 Norethisterone acetate ............................................................2117
Newcastle disease vaccine (live).............................................. 781 Norethisteroni acetas ..............................................................2117
Nicergoline ................................................................................ 2091 Norethisteronum ..................................................................... 2116
Nicergolinum ........................................................................... 2091 Norfloxacin................................................................................ 2118
Nicethamidum ......................................................................... 2100 Norfloxacinum......................................................................... 2118
Nickel in polyols (2.4.15.)......................................................... 108 Norgestrel .................................................................................. 2119
Niclosamide, anhydrous .........................................................2092 Norgestrelum ............................................................................ 2119
Niclosamide monohydrate .....................................................2093 Normal immunoglobulin for intravenous administration,
Niclosamidum anhydricum..................................................2092 human ...................................................................................... 1744

3072 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Normal immunoglobulin, human ......................................... 1742 Oral solutions, emulsions and suspensions ......................... 609
Nortriptyline hydrochloride................................................... 2120 Oral use, liquid preparations for............................................. 608
Nortriptylini hydrochloridum.............................................. 2120 Orciprenaline sulphate............................................................ 2154
Noscapine .................................................................................. 2121 Orciprenalini sulfas................................................................ 2154
Noscapine hydrochloride........................................................ 2122 Oregano...................................................................................... 2155
Noscapini hydrochloridum................................................... 2122 Organ preservation, solutions for.........................................2458
Noscapinum.............................................................................. 2121 Origani herba........................................................................... 2155
Nuclear magnetic resonance spectrometry (2.2.33.).............51 Orodispensible tablets............................................................... 628
Nucleic acid amplification techniques (2.6.21.)....................174 Oromucosal capsules ................................................................ 613
Nucleic acids in polysaccharide vaccines (2.5.17.) .............. 132 Oromucosal drops, oromucosal sprays and sublingual
Nutmeg oil ................................................................................. 2123 sprays.......................................................................................... 612
Nystatin ...................................................................................... 2124 Oromucosal preparations..........................................................611
Nystatinum ............................................................................... 2124 Oromucosal preparations, semi-solid..................................... 612
Oromucosal solutions and oromucosal suspensions ......... 612
O Orphenadrine citrate............................................................... 2156
O-Acetyl in polysaccharide vaccines (2.5.19.) ...................... 132 Orphenadrine hydrochloride................................................. 2157
Oak bark .................................................................................... 2129 Orphenadrini citras................................................................ 2156
Octoxinol 10 .............................................................................. 2129 Orphenadrini hydrochloridum............................................ 2157
Octoxinolum 10 ....................................................................... 2129 Orthosiphonis folium ............................................................. 1859
Octyldodecanol......................................................................... 2130 Oryzae amylum .......................................................................2369
Octyldodecanolum .................................................................. 2130 Osmolality (2.2.35.)...................................................................... 54
Octyl gallate .............................................................................. 2129 Other provisions applying to general chapters and
Octylis gallas ............................................................................ 2129 monographs (1.2.).........................................................................5
Odour (2.3.4.)................................................................................ 99 Ouabain...................................................................................... 2158
Odour and taste of essential oils (2.8.8.) ...............................216 Ouabainum ............................................................................... 2158
Oenotherae oleum raffinatum ......................................5.1-2921 Oxaliplatin ................................................................................. 2159
Ofloxacin.................................................................................... 2131 Oxaliplatinum .......................................................................... 2159
Ofloxacinum............................................................................. 2131 Oxazepam .................................................................................. 2162
Oils rich in omega-3- acids, composition of fatty acids Oxazepamum ........................................................................... 2162
(2.4.29.) ...................................................................................... 121 Oxeladin hydrogen citrate...................................................... 2163
Ointments .................................................................................... 625 Oxeladini hydrogenocitras ................................................... 2163
Oleae folium ............................................................................. 2134 Oxfendazole for veterinary use............................................. 2164
Olea herbaria ............................................................................ 595 Oxfendazolum ad usum veterinarium .............................. 2164
Oleic acid ................................................................................... 2132 Oxidising substances (2.5.30.)................................................. 137
Oleoyl macrogolglycerides..................................................... 2133 Oxolinic acid.............................................................................. 2165
Oleyl alcohol ............................................................................. 2134 Oxprenolol hydrochloride ...................................................... 2166
Olivae oleum raffinatum ....................................................... 2135 Oxprenololi hydrochloridum .............................................. 2166
Olivae oleum virginale .......................................................... 2136 Oxybuprocaine hydrochloride............................................... 2167
Olive leaf .................................................................................... 2134 Oxybuprocaini hydrochloridum ......................................... 2167
Olive oil, refined ....................................................................... 2135 Oxybutynin hydrochloride ..................................................... 2168
Olive oil, virgin ......................................................................... 2136 Oxybutynini hydrochloridum .............................................. 2168
Olsalazine sodium.................................................................... 2137 Oxycodone hydrochloride ...............................................5.1-2987
Olsalazinum natricum........................................................... 2137 Oxycodoni hydrochloridum ..........................................5.1-2987
Omega-3-acid ethyl esters 60................................................. 2140 Oxygen........................................................................................ 2169
Omega-3-acid ethyl esters 90................................................. 2142 Oxygen (15O) ................................................................................ 837
Omega-3 acidorum esteri ethylici 60................................. 2140 Oxygen-flask method (2.5.10.)................................................. 130
Omega-3 acidorum esteri ethylici 90................................. 2142 Oxygen in gases (2.5.27.).......................................................... 136
Omega-3 acidorum triglycerida .......................................... 2144 Oxygenium................................................................................ 2169
Omega-3-acids, composition of fatty acids in oils rich in Oxygenium (15O)........................................................................ 837
(2.4.29.) ...................................................................................... 121 Oxymetazoline hydrochloride ............................................... 2170
Omega-3-acids, fish oil rich in ...............................................1595 Oxymetazolini hydrochloridum .......................................... 2170
Omega-3-acid triglycerides ..................................................... 2144 Oxytetracycline dihydrate ...................................................... 2171
Omeprazole ............................................................................... 2146 Oxytetracycline hydrochloride .............................................. 2172
Omeprazole sodium................................................................. 2148 Oxytetracyclini hydrochloridum......................................... 2172
Omeprazolum........................................................................... 2146 Oxytetracyclinum dihydricum............................................. 2171
Omeprazolum natricum........................................................ 2148 Oxytocin ......................................................................................2174
Ondansetron hydrochloride dihydrate ................................ 2149 Oxytocin bulk solution ........................................................... 2175
Ondansetroni hydrochloridum dihydricum .................... 2149 Oxytocini solutio ..................................................................... 2175
Ononidis radix ......................................................................... 2361 Oxytocinum ...............................................................................2174
Opalescence of liquids, clarity and degree (2.2.1.) ............... 23
Ophthalmica ............................................................................... 602 P
Ophthalmic inserts .................................................................... 604 Palmitic acid.............................................................................. 2179
Opii pulvis normatus ............................................................. 2151 Pancreas powder ...................................................................... 2179
Opium crudum ........................................................................ 2152 Pancreatis pulvis ..................................................................... 2179
Opium, prepared....................................................................... 2151 Pancuronii bromidum ........................................................... 2182
Opium, raw ................................................................................ 2152 Pancuronium bromide ............................................................ 2182
Optical rotation (2.2.7.)............................................................... 28 Pansy, wild (flowering aerial parts) .....................................2700
Oral drops .................................................................................... 609 Papaverine hydrochloride ...................................................... 2183
Oral powders................................................................................617 Papaverini hydrochloridum................................................. 2183

General Notices (1) apply to all monographs and other texts 3073
Index EUROPEAN PHARMACOPOEIA 5.1

Papaveris rhoeados flos ........................................................2359 Peptide mapping (2.2.55.) .......................................................... 82


Paper chromatography (2.2.26.)............................................... 40 Peptides, synthetic, acetic acid in (2.5.34.)............................141
Paracetamol .............................................................................. 2184 Pergolide mesilate....................................................................2209
Paracetamolum........................................................................ 2184 Pergolidi mesilas .....................................................................2209
Paraffin, hard ............................................................................ 2186 Perindopril tert-butylamine.................................................... 2210
Paraffin, light liquid ................................................................ 2186 Peritoneal dialysis, solutions for........................................... 2212
Paraffin, liquid .......................................................................... 2187 Peroxide value (2.5.5.)............................................................... 128
Paraffinum liquidum.............................................................. 2187 Perphenazine ............................................................................ 2214
Paraffinum perliquidum ....................................................... 2186 Perphenazinum....................................................................... 2214
Paraffinum solidum................................................................ 2186 Pertussis (acellular, component), diphtheria, tetanus,
Paraffin, white soft .................................................................. 2187 poliomyelitis (inactivated) and haemophilus type b
Paraffin, yellow soft................................................................. 2188 conjugate vaccine (adsorbed)................................................ 653
Parainfluenza virus vaccine (live), bovine, freeze-dried .... 732 Pertussis, diphtheria, tetanus and poliomyelitis (inactivated)
Parainfluenza virus vaccine (live), canine ............................ 742 vaccine (adsorbed)................................................................... 656
Paraldehyde............................................................................... 2189 Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) and
Paraldehydum.......................................................................... 2189 haemophilus type b conjugate vaccine (adsorbed) .......... 657
Parenteralia .......................................................................5.1-2841 Pertussis vaccine........................................................................ 685
Parenteral preparations...................................................5.1-2841 Pertussis vaccine (acellular), assay of (2.7.16.).................... 208
Parenteral preparations, test for extractable volume of Pertussis vaccine (acellular, component, adsorbed) .......... 686
(2.9.17.)....................................................................................... 243 Pertussis vaccine (acellular, co-purified, adsorbed) ........... 688
Parnaparin sodium .................................................................. 2189 Pertussis vaccine (adsorbed) ................................................... 690
Parnaparinum natricum....................................................... 2189 Pertussis vaccine, assay of (2.7.7.) .......................................... 197
Paroxetine hydrochloride hemihydrate............................... 2190 Peru balsam............................................................................... 2215
Paroxetini hydrochloridum hemihydricum ..................... 2190 Pessaries....................................................................................... 629
Particles, fine, aerodynamic assessment of in preparations Pessaries and suppositories, disintegration of (2.9.2.) ...... 227
for inhalation (2.9.18.) ...................................................5.1-2799 Pessaries and suppositories, resistance to rupture
Particle size by microscopy, limit test of (2.9.13.) .............. 239 (2.9.24.) ...................................................................................... 258
Particulate contamination : sub-visible particles Pesticide residues (2.8.13.)........................................................218
(2.9.19.) ...................................................................................... 253 Pethidine hydrochloride......................................................... 2216
Particulate contamination : visible particles (2.9.20.)........ 255 Pethidini hydrochloridum .................................................... 2216
Parvovirosis vaccine (inactivated), canine ............................ 743 Pharmaceutical technical procedures (2.9.)......................... 225
Parvovirosis vaccine (inactivated), porcine .......................... 787 Pharmacognosy, methods in (2.8.)......................................... 215
Parvovirosis vaccine (live), canine.......................................... 744 Pharmacopoeial harmonisation (5.8.) ................................... 551
Passiflorae herba..................................................................... 2192 Phenazone................................................................................. 2217
Passion flower .......................................................................... 2192 Phenazonum ............................................................................ 2217
Pastes............................................................................................ 625 Pheniramine maleate .............................................................. 2218
Pasteurella vaccine (inactivated) for sheep .......................... 783 Pheniramini maleas............................................................... 2218
Pastilles and lozenges............................................................... 613 Phenobarbital ........................................................................... 2219
Patches, transdermal..................................................................616 Phenobarbital sodium.............................................................2220
Patches, transdermal, dissolution test for (2.9.4.) .............. 231 Phenobarbitalum..................................................................... 2219
Pefloxacini mesilas dihydricus ........................................... 2193 Phenobarbitalum natricum..................................................2220
Pefloxacin mesilate dihydrate ............................................... 2193 Phenol ........................................................................................ 2221
Penbutololi sulfas.................................................................... 2195 Phenol in immunosera and vaccines (2.5.15.)......................131
Penbutolol sulphate ................................................................ 2195 Phenolphthalein.......................................................................2222
Penetrometry, measurement of consistency (2.9.9.) .......... 235 Phenolphthaleinum................................................................2222
Penicillamine............................................................................. 2196 Phenolsulfonphthalein ...........................................................2222
Penicillaminum ....................................................................... 2196 Phenolsulfonphthaleinum ....................................................2222
Pentaerythrityli tetranitras dilutus..................................... 2198 Phenolum.................................................................................. 2221
Pentaerythrityl tetranitrate, diluted .................................... 2198 Phenothiazines, identification by thin-layer chromatography
Pentamidine diisetionate........................................................ 2199 (2.3.3.) .......................................................................................... 99
Pentamidini diisetionas ........................................................ 2199 Phenoxyethanol........................................................................2223
Pentazocine........................................................................5.1-2991 Phenoxyethanolum ................................................................2223
Pentazocine hydrochloride .............................................5.1-2991 Phenoxymethylpenicillin .................................................5.1-2992
Pentazocine lactate ..........................................................5.1-2992 Phenoxymethylpenicillin potassium .............................5.1-2994
Pentazocini hydrochloridum ........................................5.1-2991 Phenoxymethylpenicillinum.........................................5.1-2992
Pentazocini lactas............................................................5.1-2992 Phenoxymethylpenicillinum kalicum ........................5.1-2994
Pentazocinum ...................................................................5.1-2991 Phentolamine mesilate ...........................................................2227
Pentobarbital ............................................................................ 2201 Phentolamini mesilas ............................................................2227
Pentobarbital sodium..............................................................2202 Phenylalanine ...........................................................................2228
Pentobarbitalum...................................................................... 2201 Phenylalaninum......................................................................2228
Pentobarbitalum natricum ...................................................2202 Phenylbutazone .......................................................................2229
Pentoxifylline ............................................................................2203 Phenylbutazonum...................................................................2229
Pentoxifyllinum .......................................................................2203 Phenylephrine........................................................................... 2231
Pentoxyverine hydrogen citrate............................................2204 Phenylephrine hydrochloride................................................2232
Pentoxyverini hydrogenocitras ...........................................2204 Phenylephrini hydrochloridum ..........................................2232
Peppermint leaf ........................................................................2205 Phenylephrinum ..................................................................... 2231
Peppermint oil ..........................................................................2206 Phenylhydrargyri acetas .......................................................2232
Pepsini pulvis...........................................................................2207 Phenylhydrargyri boras.........................................................2233
Pepsin powder ..........................................................................2207 Phenylhydrargyri nitras........................................................2234

3074 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Phenylmercuric acetate ..........................................................2232 Plasma for fractionation, human .......................................... 1746


Phenylmercuric borate ...........................................................2233 Plasma, human (pooled and treated for virus
Phenylmercuric nitrate ...........................................................2234 inactivation) ............................................................................ 1747
Phenylpropanolamine hydrochloride ..................................2234 Plasma humanum ad separationem.................................. 1746
Phenylpropanolamini hydrochloridum............................2234 Plasma humanum collectum deinde conditum ad viros
Phenytoin...................................................................................2235 exstinguendos ........................................................................ 1747
Phenytoin sodium....................................................................2236 Plastic additives (3.1.13.).......................................................... 293
Phenytoinum............................................................................2235 Plastic containers and closures for pharmaceutical use
Phenytoinum natricum .........................................................2236 (3.2.2.) ........................................................................................ 308
Pholcodine.................................................................................2237 Plastic containers for aqueous solutions for parenteral
Pholcodinum ............................................................................2237 infusion (3.2.2.1.) ..................................................................... 309
Phosphates (2.4.11.) .................................................................. 108 Plastic containers for human blood and blood components,
Phosphoric acid, concentrated .............................................2237 sterile (3.2.3.) ............................................................................ 309
Phosphoric acid, dilute ...........................................................2238 Plastic syringes, single-use, sterile (3.2.8.) ............................314
Phosphorus in polysaccharide vaccines (2.5.18.) ............... 132 Pneumococcal polysaccharide conjugate vaccine
pH, potentiometric determination of (2.2.3.) ......................... 26 (adsorbed).........................................................................5.1-2851
Phthalylsulfathiazole ..............................................................2238 Pneumococcal polysaccharide vaccine ................................. 691
Phthalylsulfathiazolum .........................................................2238 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis
Physical and physicochemical methods (2.2.) ....................... 23 (acellular, component) vaccine (adsorbed) ........................ 648
Physostigmine salicylate.........................................................2239 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis
Physostigmine sulphate..........................................................2240 vaccine (adsorbed)................................................................... 656
Physostigmini salicylas .........................................................2239 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis
Physostigmini sulfas ..............................................................2240 (acellular, component) and haemophilus type b conjugate
Phytomenadione ...................................................................... 2241 vaccine (adsorbed)................................................................... 653
Phytomenadionum ................................................................. 2241 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis and
Phytosterol ................................................................................2242 haemophilus type b conjugate vaccine (adsorbed) .......... 657
Phytosterolum..........................................................................2242 Poliomyelitis vaccine (inactivated) ......................................... 692
Picotamide monohydrate .......................................................2243 Poliomyelitis vaccine (inactivated), in vivo assay of
Picotamidum monohydricum..............................................2243 (2.7.20.) .......................................................................................210
Pilocarpine hydrochloride......................................................2244 Poliomyelitis vaccine (oral) ...................................................... 695
Pilocarpine nitrate ...................................................................2246 Poliomyelitis vaccine (oral), test for neurovirulence
Pilocarpini hydrochloridum ................................................2244 (2.6.19.) ...................................................................................... 172
Pilocarpini nitras....................................................................2246 Poloxamera...............................................................................2264
Pimozide ....................................................................................2247 Poloxamers ................................................................................2264
Pimozidum ...............................................................................2247 Polyacrylate dispersion 30 per cent.....................................2265
Pindolol......................................................................................2248 Polyacrylatis dispersio 30 per centum..............................2265
Pindololum ...............................................................................2248 Poly(alcohol vinylicus) ..........................................................2272
Pipemidic acid trihydrate .......................................................2249 Polyamide 6/6 suture, sterile, in distributor for veterinary
Piperacillin ................................................................................2250 use .............................................................................................. 887
Piperacillin sodium..................................................................2252 Polyamide 6 suture, sterile, in distributor for veterinary use
Piperacillinum ........................................................................2250 ..................................................................................................... 886
Piperacillinum natricum ......................................................2252 Polyethyleneglycols ................................................................. 1950
Piperazine adipate ...................................................................2253 Polyethylene terephthalate for containers for preparations
Piperazine citrate.....................................................................2254 not for parenteral use (3.1.15.) ............................................. 298
Piperazine hydrate...................................................................2255 Poly(ethylene terephthalate) suture, sterile, in distributor for
Piperazini adipas....................................................................2253 veterinary use .......................................................................... 887
Piperazini citras ......................................................................2254 Poly(ethylene - vinyl acetate) for containers and tubing for
Piperazinum hydricum .........................................................2255 total parenteral nutrition preparations (3.1.7.) ................. 285
Piracetam...................................................................................2256 Polyethylene with additives for containers for parenteral
Piracetamum ............................................................................2256 preparations and for ophthalmic preparations (3.1.5.) ... 279
Pirenzepine dihydrochloride monohydrate .......................2257 Polyethylene without additives for containers for parenteral
Pirenzepini dihydrochloridum monohydricum .............2257 preparations and for ophthalmic preparations (3.1.4.) ... 278
Piretanide ..................................................................................2258 Polygalae radix ........................................................................ 2401
Piretanidum..............................................................................2258 Polygoni avicularis herba..................................................... 1877
Piroxicam ...................................................................................2259 Polymorphism (5.9.) .................................................................. 555
Piroxicamum............................................................................2259 Polymyxin B sulphate .............................................................2266
Piscis oleum omega-3 acidis abundans ............................1595 Polymyxini B sulfas................................................................2266
Pivampicillin.............................................................................. 2261 Polyolefines (3.1.3.) ................................................................... 274
Pivampicillinum...................................................................... 2261 Polyoxyl castor oil.................................................................... 1949
Pivmecillinam hydrochloride.................................................2262 Polyoxyl hydrogenated castor oil ......................................... 1948
Pivmecillinami hydrochloridum ........................................2262 Polypropylene for containers and closures for parenteral
Plantae ad ptisanam ................................................................ 573 preparations and ophthalmic preparations (3.1.6.).......... 282
Plantae medicinales ................................................................. 572 Polysaccharide vaccines, hexosamines in (2.5.20.)............. 132
Plantae medicinales Polysaccharide vaccines, methylpentoses in (2.5.21.)........ 133
ad praeparationes homoeopathicas................................... 893 Polysaccharide vaccines, nucleic acids in (2.5.17.) ............. 132
Plantae medicinales praeparatore ....................................... 572 Polysaccharide vaccines, O-acetyl in (2.5.19.)...................... 132
Plantaginis lanceolatae folium ...........................................2368 Polysaccharide vaccines, phosphorus in (2.5.18.)............... 132
Plantaginis ovatae semen..................................................... 1850 Polysaccharide vaccines, protein in (2.5.16.) ........................131
Plantaginis ovatae seminis tegumentum ......................... 1849 Polysaccharide vaccines, ribose in (2.5.31.) ......................... 137

General Notices (1) apply to all monographs and other texts 3075
Index EUROPEAN PHARMACOPOEIA 5.1

Polysaccharide vaccines, sialic acid in (2.5.23.) .................. 133 Povidone ....................................................................................2289


Polysaccharide vaccines, uronic acids in (2.5.22.).............. 133 Povidone, iodinated ................................................................. 2291
Polysorbate 20 ..........................................................................2267 Povidonum................................................................................2289
Polysorbate 40 ..........................................................................2268 Povidonum iodinatum........................................................... 2291
Polysorbate 60 ..........................................................................2269 Powdered cellulose ..................................................................1232
Polysorbate 80 ..........................................................................2270 Powders and granules for oral solutions and
Polysorbatum 20 .....................................................................2267 suspensions............................................................................... 609
Polysorbatum 40 .....................................................................2268 Powders and granules for syrups ............................................610
Polysorbatum 60 .....................................................................2269 Powders and tablets for rectal solutions and suspensions.. 624
Polysorbatum 80 .....................................................................2270 Powders, ear................................................................................ 602
Poly(vinyl acetate)....................................................................2271 Powders, effervescent.................................................................617
Poly(vinyl alcohol) ...................................................................2272 Powders for cutaneous application.........................................616
Poly(vinyl chloride), non-plasticised, materials based on for Powders for eye-drops and powders for eye lotions ........... 603
containers for dry dosage forms for oral administration Powders for inhalation.....................................................5.1-2845
(3.1.11.)....................................................................................... 291 Powders for injections or infusions ..............................5.1-2842
Poly(vinyl chloride), non-plasticised, materials based on Powders for oral drops.............................................................. 609
for containers for non-injectable aqueous solutions Powders, nasal .............................................................................611
(3.1.10.) ...................................................................................... 289 Powders, oral ...............................................................................617
Poly(vinyl chloride), plasticised, empty sterile containers of Praeadmixta ad alimenta medicata
for human blood and blood components (3.2.4.) ..............311 ad usum veterinarium............................................................617
Poly(vinyl chloride), plasticised, materials based on for Praeparationes ad irrigationem............................................ 622
containers for aqueous solutions for intravenous infusion Praeparationes buccales ..........................................................611
(3.1.14.) ...................................................................................... 296 Praeparationes homoeopathicas .......................................... 893
Poly(vinyl chloride), plasticised, materials based on for Praeparationes insulini iniectabiles .................................. 1808
containers for human blood and blood components Praeparationes intramammariae
(3.1.1.1.) ..................................................................................... 269 ad usum veterinarium........................................................... 606
Poly(vinyl chloride), plasticised, materials based on for Praeparationes intraruminales ............................................. 607
tubing used in sets for the transfusion of blood and blood Praeparationes liquidae ad usum dermicum .................... 607
components (3.1.1.2.).............................................................. 272 Praeparationes liquidae peroraliae...................................... 608
Poly (vinyl chloride), plasticised, sterile containers of Praeparationes liquidae veterinariae ad usum dermicum
for human blood containing anticoagulant solution ..................................................................................................... 630
(3.2.5.) ........................................................................................ 312 Praeparationes molles ad usum dermicum ....................... 624
Poly(vinylis acetas).................................................................2271 Praeparationes pharmaceuticae in vasis cum pressu..... 622
Poppy petals, red......................................................................2359 Pravastatin sodium ..................................................................2292
Porcine actinobacillosis vaccine (inactivated) ..................... 784 Pravastatinum natricum .......................................................2292
Porcine influenza vaccine (inactivated) ................................ 785 Prazepam ...................................................................................2293
Porcine insulin.......................................................................... 1806 Prazepamum ............................................................................2293
Porcine parvovirosis vaccine (inactivated) ........................... 787 Praziquantel ..............................................................................2294
Porcine progressive atrophic rhinitis vaccine Praziquantelum.......................................................................2294
(inactivated) .............................................................................. 788 Prazosin hydrochloride ..........................................................2295
Porosity of sintered-glass filters (2.1.2.)...................................17 Prazosini hydrochloridum ...................................................2295
Potassium (2.4.12.) .................................................................... 108 Prednicarbate............................................................................2297
Potassium acetate ....................................................................2273 Prednicarbatum.......................................................................2297
Potassium bromide ..................................................................2273 Prednisolone .............................................................................2298
Potassium carbonate............................................................... 2274 Prednisolone acetate...............................................................2299
Potassium chloride ..................................................................2275 Prednisolone pivalate.............................................................. 2301
Potassium citrate .....................................................................2275 Prednisolone sodium phosphate ..........................................2302
Potassium clavulanate ............................................................ 2276 Prednisoloni acetas ................................................................2299
Potassium clavulanate, diluted .............................................2278 Prednisoloni natrii phosphas ..............................................2302
Potassium dihydrogen phosphate ........................................2280 Prednisoloni pivalas............................................................... 2301
Potassium hydrogen aspartate hemihydrate .....................2280 Prednisolonum ........................................................................2298
Potassium hydrogen carbonate ............................................ 2281 Prednisone.................................................................................2303
Potassium hydrogen tartrate.................................................2282 Prednisonum............................................................................2303
Potassium hydroxide ...............................................................2283 Prekallikrein activator (2.6.15.) .............................................. 168
Potassium iodide......................................................................2283 Premixes for medicated feeding stuffs for veterinary use ..617
Potassium metabisulphite......................................................2284 Preparations for inhalation.............................................5.1-2843
Potassium nitrate .....................................................................2284 Preparations for inhalation : aerodynamic assessment of fine
Potassium perchlorate ............................................................2285 particles (2.9.18.) ............................................................5.1-2799
Potassium permanganate.......................................................2286 Preparations for irrigation ....................................................... 622
Potassium sodium tartrate tetrahydrate.............................2286 Pressurised pharmaceutical preparations ............................ 622
Potassium sorbate....................................................................2287 Prilocaine...................................................................................2305
Potassium sulphate .................................................................2288 Prilocaine hydrochloride........................................................2307
Potato starch.............................................................................2288 Prilocaini hydrochloridum...................................................2307
Potentiometric determination of ionic concentration using Prilocainum..............................................................................2305
ion-selective electrodes (2.2.36.)............................................. 55 Primaquine diphosphate ........................................................2308
Potentiometric determination of pH (2.2.3.).......................... 26 Primaquini diphosphas.........................................................2308
Potentiometric titration (2.2.20.).............................................. 35 Primary aromatic amino-nitrogen, determination of
Poultices....................................................................................... 625 (2.5.8.) ........................................................................................ 129
Pour-on preparations ................................................................ 631 Primary standards for volumetric solutions (4.2.1.)........... 435

3076 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Primidone ..................................................................................2309 Protein, total (2.5.33.) ............................................................... 138


Primidonum .............................................................................2309 Prothrombin complex, human .............................................. 1748
Primulae radix......................................................................... 2310 Prothrombinum multiplex humanum ............................... 1748
Primula root .............................................................................. 2310 Protirelin ....................................................................................2335
Probenecid................................................................................. 2311 Protirelinum .............................................................................2335
Probenecidum.......................................................................... 2311 Proxyphylline ............................................................................2336
Procainamide hydrochloride ................................................. 2312 Proxyphyllinum.......................................................................2336
Procainamidi hydrochloridum............................................ 2312 Pruni africanae cortex ..........................................................2339
Procaine benzylpenicillin ....................................................... 1080 Pseudoephedrine hydrochloride ..........................................2337
Procaine hydrochloride .......................................................... 2312 Pseudoephedrini hydrochloridum .....................................2337
Procaini hydrochloridum ..................................................... 2312 Psyllii semen ............................................................................2338
Prochlorperazine maleate ...................................................... 2313 Psyllium seed ............................................................................2338
Prochlorperazini maleas....................................................... 2313 Pulveres ad usum dermicum ..................................................616
Producta ab ADN recombinante ........................................... 584 Pulveres perorales......................................................................617
Producta ab fermentatione..................................................... 576 Purified water ...........................................................................2697
Producta allergenica ................................................................ 569 Purified water, highly .............................................................2695
Producta cum possibili transmissione vectorium Pycnometric density of solids (2.9.23.) ................................. 257
enkephalopathiarum spongiformium animalium ......... 577 Pygeum africanum bark .........................................................2339
Products of fermentation ......................................................... 576 Pyrantel embonate...................................................................2339
Products of recombinant DNA technology .......................... 584 Pyranteli embonas ..................................................................2339
Products with risk of transmitting agents of animal Pyrazinamide ............................................................................2340
spongiform encephalopathies............................................... 577 Pyrazinamidum.......................................................................2340
Progesterone ............................................................................. 2314 Pyridostigmine bromide ......................................................... 2341
Progesteronum ........................................................................ 2314 Pyridostigmini bromidum .................................................... 2341
Proguanil hydrochloride ........................................................ 2315 Pyridoxine hydrochloride.......................................................2342
Proguanili hydrochloridum ................................................. 2315 Pyridoxini hydrochloridum .................................................2342
Proline ........................................................................................ 2316 Pyrimethamine .........................................................................2343
Prolinum ................................................................................... 2316 Pyrimethaminum....................................................................2343
Promazine hydrochloride....................................................... 2317 Pyrogens (2.6.8.)......................................................................... 152
Promazini hydrochloridum.................................................. 2317
Promethazine hydrochloride................................................. 2318 Q
Promethazini hydrochloridum............................................ 2318 Quercus cortex ......................................................................... 2129
Propacetamol hydrochloride ................................................. 2319 Quinidine sulphate ..................................................................2347
Propacetamoli hydrochloridum .......................................... 2319 Quinine hydrochloride............................................................2348
Propafenone hydrochloride ............................................5.1-2996 Quinine sulphate......................................................................2350
Propafenoni hydrochloridum .......................................5.1-2996
Propanol.....................................................................................2320
R
Propanolum..............................................................................2320
Propantheline bromide........................................................... 2321 Rabies immunoglobulin, human .......................................... 1750
Propanthelini bromidum ...................................................... 2321 Rabies vaccine for human use prepared in cell cultures... 699
Propofol......................................................................................2322 Rabies vaccine (inactivated) for veterinary use................... 790
Propofolum ...............................................................................2322 Rabies vaccine (live, oral) for foxes ........................................ 792
Propranolol hydrochloride.....................................................2324 Racemic camphor..................................................................... 1172
Propranololi hydrochloridum..............................................2324 Racemic ephedrine hydrochloride .......................................1509
Propylene glycol.......................................................................2327 Racemic menthol ..................................................................... 1991
Propylene glycol dicaprylocaprate.......................................2327 Raclopride ([11C]methoxy) injection....................................... 838
Propylene glycol dilaurate .....................................................2328 Raclopridi ([11C]methoxy) solutio iniectabilis ................... 838
Propylene glycol monolaurate ..............................................2329 Radionuclides, table of physical characteristics (5.7.) ....... 539
Propylene glycol monopalmitostearate...............................2330 Radiopharmaceutica................................................................ 578
Propylene glycol monostearate.............................................2330 Radiopharmaceutical preparations ........................................ 578
Propylenglycoli dicaprylocapras ........................................2327 Raman spectrometry (2.2.48.) ................................................... 79
Propylenglycoli dilauras .......................................................2328 Ramipril......................................................................................2355
Propylenglycoli monolauras................................................2329 Ramiprilum ..............................................................................2355
Propylenglycoli monopalmitostearas................................2330 Ranitidine hydrochloride.................................................5.1-3001
Propylenglycolum...................................................................2327 Ranitidini hydrochloridum ...........................................5.1-3001
Propyl gallate............................................................................2325 Rapae oleum raffinatum .......................................................2359
Propylis gallas..........................................................................2325 Rapeseed oil, refined...............................................................2359
Propylis parahydroxybenzoas .............................................2326 Ratanhiae radix .......................................................................2362
Propylis parahydroxybenzoas natricum ..........................2448 Ratanhiae tinctura..................................................................2362
Propyl parahydroxybenzoate.................................................2326 Reagents (4.) ............................................................................... 321
Propylthiouracil ....................................................................... 2331 Reagents (4.1.1.)......................................................................... 321
Propylthiouracilum ................................................................ 2331 Reagents (4.1.1.)................................................................ 5.1-2817
Propyphenazone ......................................................................2332 Reagents, standard solutions, buffer solutions (4.1.)......... 321
Propyphenazonum .................................................................2332 Recombinant DNA technology, products of......................... 584
Protamine hydrochloride .......................................................2332 Rectal capsules ........................................................................... 623
Protamine sulphate .................................................................2334 Rectal foams................................................................................ 624
Protamini hydrochloridum ..................................................2332 Rectalia ........................................................................................ 623
Protamini sulfas ......................................................................2334 Rectal preparations.................................................................... 623
Protein in polysaccharide vaccines (2.5.16.) .........................131 Rectal preparations, semi-solid ............................................... 624

General Notices (1) apply to all monographs and other texts 3077
Index EUROPEAN PHARMACOPOEIA 5.1

Rectal solutions, emulsions and suspensions...................... 624 Rutosidum trihydricum......................................................... 2381


Rectal tampons........................................................................... 624
Red poppy petals......................................................................2359 S
Refractive index (2.2.6.) .............................................................. 28 Sabalis serrulatae fructus .....................................................2398
Relationship between reaction of solution, approximate pH Saccharin ...................................................................................2387
and colour of certain indicators (2.2.4.) ............................... 27 Saccharin sodium ....................................................................2388
Relative density (2.2.5.)............................................................... 27 Saccharinum ............................................................................2387
Reserpine ...................................................................................2360 Saccharinum natricum .........................................................2388
Reserpinum ..............................................................................2360 Sacchari spheri........................................................................2503
Residual solvents (5.4.) ............................................................. 507 Saccharum................................................................................2499
Residual solvents, identification and control (2.4.24.) ...... 113 Safflower oil, refined ...............................................................2389
Residue on evaporation of essential oils (2.8.9.)..................216 Saffron for homoeopathic preparations................................ 900
Resistance to crushing of tablets (2.9.8.) ............................. 235 Sage leaf (salvia officinalis)....................................................2389
Resistance to rupture of suppositories and pessaries Sage leaf, three-lobed..............................................................2390
(2.9.24.) ...................................................................................... 258 Sage tincture............................................................................. 2391
Resorcinol ..................................................................................2360 Salbutamol ................................................................................ 2391
Resorcinolum ...........................................................................2360 Salbutamoli sulfas .................................................................2393
Restharrow root ....................................................................... 2361 Salbutamol sulphate ...............................................................2393
Rhamni purshianae cortex................................................... 1194 Salbutamolum.......................................................................... 2391
Rhatany root .............................................................................2362 Salicis cortex ............................................................................2702
Rhatany tincture ......................................................................2362 Salicylic acid.......................................................................5.1-3007
Rhei radix..................................................................................2363 Salmonis domestici oleum ...................................................2396
Rhenii sulfidi colloidalis et technetii (99mTc) solutio Salmon oil, farmed...................................................................2396
iniectabilis ................................................................................ 851 Salviae officinalis folium ......................................................2389
Rhubarb .....................................................................................2363 Salviae sclareae aetheroleum .............................................. 1311
Ribavirin..............................................................................5.1-3002 Salviae tinctura ....................................................................... 2391
Ribavirinum ......................................................................5.1-3002 Salviae trilobae folium ..........................................................2390
Riboflavin...................................................................................2365 Sambuci flos............................................................................. 1496
Riboflavini natrii phosphas .................................................2366 Saponification value (2.5.6.).................................................... 129
Riboflavin sodium phosphate................................................2366 Saw palmetto fruit ...................................................................2398
Riboflavinum............................................................................2365 Scopolamine butylbromide .................................................... 1776
Ribose in polysaccharide vaccines (2.5.31.) ......................... 137 Scopolamine hydrobromide................................................... 1777
Ribwort plantain ......................................................................2368 Scopolamini butylbromidum ............................................... 1776
Rice starch.................................................................................2369 Scopolamini hydrobromidum.............................................. 1777
Ricini oleum hydrogenatum ................................................ 1197 Selegiline hydrochloride ........................................................2400
Ricini oleum virginale........................................................... 1197 Selegilini hydrochloridum....................................................2400
Rifabutin ....................................................................................2369 Selenii disulfidum................................................................... 2401
Rifabutinum..............................................................................2369 Selenium disulphide................................................................ 2401
Rifampicin..................................................................................2371 Semi-micro determination of water (2.5.12.) ....................... 130
Rifampicinum ..........................................................................2371 Semi-solid and liquid preparations, test for deliverable mass
Rifamycin sodium.....................................................................2372 or volume (2.9.28.) .................................................................. 263
Rifamycinum natricum .........................................................2372 Semi-solid ear preparations ..................................................... 602
Rilmenidine dihydrogen phosphate .....................................2373 Semi-solid eye preparations ..................................................... 604
Rilmenidini dihydrogenophosphas....................................2373 Semi-solid nasal preparations...................................................611
Risperidone ............................................................................... 2374 Semi-solid oromucosal preparations...................................... 612
Risperidonum .......................................................................... 2374 Semi-solid preparations for cutaneous application ............ 624
Roman chamomile flower ......................................................1245 Semi-solid rectal preparations................................................. 624
Rosae pseudo-fructus ............................................................. 1472 Semi-solid vaginal preparations.............................................. 630
Roselle ........................................................................................ 2376 Senega root ............................................................................... 2401
Rosemary leaf ...........................................................................2377 Sennae folii extractum siccum normatum.......................2403
Rosemary oil .............................................................................2378 Sennae folium..........................................................................2402
Rosmarini aetheroleum.........................................................2378 Sennae fructus acutifoliae....................................................2404
Rosmarini folium ....................................................................2377 Sennae fructus angustifoliae ...............................................2405
Rotating viscometer method (2.2.10.) ..................................... 30 Senna leaf ..................................................................................2402
Roxithromycin...........................................................................2379 Senna leaf dry extract, standardised ...................................2403
Roxithromycinum ...................................................................2379 Senna pods, Alexandrian........................................................2404
RRR-α-Tocopherol ................................................................... 2591 Senna pods, Tinnevelly...........................................................2405
RRR-α-Tocopherolum ............................................................ 2591 Separation techniques, chromatographic (2.2.46.) .............. 69
RRR-α-Tocopheryl acetate.....................................................2595 Serine..........................................................................................2406
RRR-α-Tocopheryl hydrogen succinate .......................5.1-3026 Serinum.....................................................................................2406
RRR-α-Tocopherylis acetas ..................................................2595 Serpylli herba........................................................................... 2701
RRR-α-Tocopherylis hydrogenosuccinas...................5.1-3026 Sertaconazole nitrate..............................................................2407
Rubber closures for containers for aqueous parenteral Sertaconazoli nitras ...............................................................2407
preparations, for powders and for freeze-dried powders Sesame oil, refined ..................................................................2408
(3.2.9.) .........................................................................................316 Sesami oleum raffinatum .....................................................2408
Rubella immunoglobulin, human......................................... 1751 Sets for the transfusion of blood and blood components
Rubella vaccine (live) ................................................................ 701 (3.2.6.) .........................................................................................313
Rusci rhizoma.......................................................................... 1138 Shampoos .................................................................................... 608
Rutoside trihydrate.................................................................. 2381 Shellac .......................................................................................2409

3078 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Sialic acid in polysaccharide vaccines (2.5.23.)................... 133 Sodium perborate, hydrated..................................................2444


Sieves (2.1.4.) .................................................................................18 Sodium pertechnetate (99mTc) injection (fission) ................ 847
Sieve test (2.9.12.)...................................................................... 239 Sodium pertechnetate (99mTc) injection (non-fission) ........ 848
Silica ad usum dentalem....................................................... 2411 Sodium phosphate (32P) injection .......................................... 849
Silica, colloidal anhydrous ..................................................... 2410 Sodium picosulfate .................................................................2445
Silica, colloidal hydrated ........................................................ 2411 Sodium polystyrene sulphonate ...........................................2446
Silica colloidalis anhydrica.................................................. 2410 Sodium propionate ..................................................................2447
Silica colloidalis hydrica....................................................... 2411 Sodium propyl parahydroxybenzoate..................................2448
Silica, dental type..................................................................... 2411 Sodium salicylate .....................................................................2449
Silicone elastomer for closures and tubing (3.1.9.)............ 288 Sodium selenite pentahydrate ..............................................2449
Silicone oil used as a lubricant (3.1.8.) ................................. 287 Sodium (S)-lactate solution ...................................................2439
Silk suture, sterile, braided, in distributor for veterinary use Sodium starch glycolate (type A) .........................................2450
..................................................................................................... 887 Sodium starch glycolate (type B) ......................................... 2451
Silver nitrate ............................................................................. 2412 Sodium starch glycolate (type C) ......................................... 2451
Silybi mariani fructus............................................................2046 Sodium stearate .......................................................................2452
Simeticone................................................................................. 2412 Sodium stearyl fumarate ........................................................2453
Simeticonum ............................................................................ 2412 Sodium sulphate, anhydrous.................................................2454
Simvastatin................................................................................ 2413 Sodium sulphate decahydrate...............................................2455
Simvastatinum......................................................................... 2413 Sodium sulphite, anhydrous..................................................2455
Single-dose preparations, uniformity of content (2.9.6.)... 234 Sodium sulphite heptahydrate..............................................2456
Single-dose preparations, uniformity of mass (2.9.5.)........ 233 Sodium thiosulphate........................................................5.1-3009
Sintered-glass filters (2.1.2.) .......................................................17 Sodium valproate .....................................................................2457
Size-exclusion chromatography (2.2.30.)................................ 45 Soft capsules ............................................................................... 600
(S)-Lactic acid............................................................................ 1883 Softening time determination of lipophilic suppositories
Sodium acetate ([1-11C]) injection........................................... 839 (2.9.22.) ...................................................................................... 256
Sodium acetate trihydrate ..................................................... 2415 Soft extracts ................................................................................ 572
Sodium alendronate ................................................................ 2416 Soiae oleum hydrogenatum .................................................2475
Sodium alginate ....................................................................... 2417 Soiae oleum raffinatum ........................................................ 2476
Sodium amidotrizoate............................................................. 2418 Solani amylum ........................................................................2288
Sodium aminosalicylate dihydrate ....................................... 2419 Solidaginis herba .................................................................... 1680
Sodium ascorbate ....................................................................2420 Solidaginis virgaureae herba............................................... 1682
Sodium benzoate ..................................................................... 2421 Solid dosage forms, dissolution test for (2.9.3.).................. 228
Sodium bromide.......................................................................2422 Solids, density of (2.2.42.).......................................................... 64
Sodium calcium edetate .........................................................2422 Solids, pycnometric density of (2.9.23.) ................................ 257
Sodium caprylate .....................................................................2423 Solubility in alcohol of essential oils (2.8.10.) ......................216
Sodium carbonate, anhydrous .......................................5.1-3008 Soluble tablets............................................................................ 628
Sodium carbonate decahydrate .....................................5.1-3008 Solutiones ad conservationem partium corporis...........2458
Sodium carbonate monohydrate ...................................5.1-3009 Solutiones ad haemocolaturam
Sodium carboxymethylcellulose ........................................... 1189 haemodiacolaturamque ...................................................... 1703
Sodium carboxymethylcellulose, cross-linked ................... 1371 Solutiones ad haemodialysim ............................................. 1700
Sodium carboxymethylcellulose, low-substituted............. 1190 Solutiones ad peritonealem dialysim ................................ 2212
Sodium cetostearyl sulphate .................................................2426 Solutiones anticoagulantes et sanguinem humanum
Sodium chloride .......................................................................2428 conservantes .......................................................................... 1007
Sodium chromate (51Cr) sterile solution ............................... 840 Solutions for haemodialysis................................................... 1700
Sodium citrate ..........................................................................2429 Solutions for haemodialysis, concentrated, water for
Sodium cromoglicate ..............................................................2429 diluting..................................................................................... 1699
Sodium cyclamate....................................................................2430 Solutions for haemofiltration and for haemodiafiltra-
Sodium dihydrogen phosphate dihydrate .......................... 2431 tion............................................................................................ 1703
Sodium fluoride .......................................................................2432 Solutions for organ preservation..........................................2458
Sodium fluoride (18F) injection ............................................... 841 Solutions for peritoneal dialysis ........................................... 2212
Sodium fusidate .......................................................................2433 Solvents, residual (5.4.) ............................................................ 507
Sodium glycerophosphate, hydrated ...................................2434 Solvents, residual, identification and control (2.4.24.)...... 113
Sodium hyaluronate ................................................................2434 Somatostatin .............................................................................2459
Sodium hydrogen carbonate .................................................2437 Somatostatinum ......................................................................2459
Sodium hydroxide....................................................................2437 Somatropin................................................................................2460
Sodium iodide...........................................................................2438 Somatropin bulk solution ......................................................2462
Sodium iodide (123I) injection .................................................. 842 Somatropin for injection ........................................................2464
Sodium iodide (131I) capsules for diagnostic use................. 843 Somatropini solutio ad praeparationem ..........................2462
Sodium iodide (131I) solution ................................................... 844 Somatropinum.........................................................................2460
Sodium iodide (131I) solution for radiolabelling .................. 845 Somatropinum ad iniectabilium.........................................2464
Sodium iodohippurate (123I) injection ................................... 845 Sorbic acid.................................................................................2467
Sodium iodohippurate (131I) injection ................................... 846 Sorbitani lauras.......................................................................2467
Sodium lactate solution..........................................................2438 Sorbitani oleas.........................................................................2468
Sodium laurilsulfate ................................................................2440 Sorbitani palmitas ..................................................................2468
Sodium metabisulphite........................................................... 2441 Sorbitani sesquioleas .............................................................2468
Sodium methyl parahydroxybenzoate................................. 2441 Sorbitani stearas .....................................................................2469
Sodium molybdate dihydrate ................................................2442 Sorbitani trioleas ....................................................................2469
Sodium nitrite...........................................................................2443 Sorbitan laurate .......................................................................2467
Sodium nitroprusside .............................................................2443 Sorbitan oleate .........................................................................2468

General Notices (1) apply to all monographs and other texts 3079
Index EUROPEAN PHARMACOPOEIA 5.1

Sorbitan palmitate ...................................................................2468 Stearoyl macrogolglycerides ................................................. 2491


Sorbitan sesquioleate..............................................................2468 Stearyl alcohol..........................................................................2492
Sorbitan stearate......................................................................2469 Sterile braided silk suture in distributor for veterinary
Sorbitan trioleate.....................................................................2469 use............................................................................................... 887
Sorbitol.......................................................................................2470 Sterile catgut............................................................................... 873
Sorbitol, liquid (crystallising)................................................2471 Sterile catgut in distributor for veterinary use ................... 885
Sorbitol, liquid (non-crystallising)........................................2472 Sterile containers of plasticised poly (vinyl chloride)
Sorbitol, liquid, partially dehydrated...................................2473 for human blood containing anticoagulant solution
Sorbitolum ................................................................................2470 (3.2.5.) ........................................................................................ 312
Sorbitolum liquidum cristallisabile....................................2471 Sterile linen thread in distributor for veterinary use......... 886
Sorbitolum liquidum non cristallisabile...........................2472 Sterile non-absorbable strands in distributor for veterinary
Sorbitolum liquidum partim deshydricum ......................2473 use............................................................................................... 888
Sotalol hydrochloride ............................................................. 2474 Sterile non-absorbable sutures ............................................... 874
Sotaloli hydrochloridum ....................................................... 2474 Sterile plastic containers for human blood and blood
Soya-bean oil, hydrogenated..................................................2475 components (3.2.3.) ................................................................. 309
Soya-bean oil, refined.............................................................. 2476 Sterile polyamide 6/6 suture in distributor for veterinary
Specific surface area by air permeability (2.9.14.).............. 239 use............................................................................................... 887
Specific surface area by gas adsorption (2.9.26.) ...... 5.1-2811 Sterile polyamide 6 suture in distributor for veterinary
Spectinomycin hydrochloride................................................ 2476 use............................................................................................... 886
Spectinomycini hydrochloridum........................................ 2476 Sterile poly(ethylene terephthalate) suture in distributor for
Spectrometry, atomic absorption (2.2.23.)............................. 36 veterinary use ........................................................................... 887
Spectrometry, atomic emission (2.2.22.)................................. 35 Sterile products, methods of preparation (5.1.1.)............... 445
Spectrometry, mass (2.2.43.) ..................................................... 65 Sterile single-use plastic syringes (3.2.8.)..............................314
Spectrometry, nuclear magnetic resonance (2.2.33.) ...........51 Sterile synthetic absorbable braided sutures ...................... 878
Spectrometry, Raman (2.2.48.) ................................................. 79 Sterile synthetic absorbable monofilament sutures........... 880
Spectrometry, X-ray fluorescence (2.2.37.)............................. 56 Sterilisation procedures, biological indicators (5.1.2.) ...... 447
Spectrophotometry, infrared absorption (2.2.24.)................ 37 Sterility (2.6.1.) ........................................................................... 145
Spectrophotometry, near-infrared (2.2.40.)............................ 59 Sterols in fatty oils (2.4.23.)............................................5.1-2787
Spectrophotometry, ultraviolet and visible absorption Sticks ............................................................................................ 626
(2.2.25.) ........................................................................................ 38 Sticks, nasal..................................................................................611
SPF chicken flocks for the production and quality control of St. John’s wort..........................................................................2485
vaccines (5.2.2.)...............................................................5.1-2825 Stomata and stomatal index (2.8.3.) ...................................... 215
Spiramycin.......................................................................... 5.1-3010 Stramonii folium .....................................................................2492
Spiramycinum .................................................................. 5.1-3010 Stramonii pulvis normatus...................................................2494
Spirapril hydrochloride monohydrate.................................2480 Stramonium leaf.......................................................................2492
Spiraprili hydrochloridum monohydricum .....................2480 Stramonium, prepared ............................................................2494
Spironolactone .........................................................................2482 Strands, sterile non-absorbable, in distributor for veterinary
Spironolactonum ....................................................................2482 use .............................................................................................. 888
Spot-on preparations................................................................. 631 Streptokinase bulk solution ..................................................2495
Sprays ........................................................................................... 631 Streptokinasi solutio ad praeparationem .........................2495
Squalane ....................................................................................2483 Streptomycini sulfas...............................................................2496
Squalanum................................................................................2483 Streptomycin sulphate ............................................................2496
Standard solutions for limit tests (4.1.2.) ............................. 426 Strontii (89Sr) chloridi solutio iniectabilis.......................... 850
Standard solutions for limit tests (4.1.2.) .................... 5.1-2818 Strontium (89Sr) chloride injection ........................................ 850
Stanni colloidalis et technetii (99mTc) Styli............................................................................................... 626
solutio iniectabilis .................................................................. 853 Sublingual tablets and buccal tablets ................................... 613
Stanni pyrophosphatis et technetii (99mTc) solutio Substances for pharmaceutical use ....................................... 586
iniectabilis ................................................................................ 865 Substances for pharmaceutical use, control of impurities
Stannosi chloridum dihydricum.........................................2486 (5.10.).......................................................................................... 559
Stannous chloride dihydrate .................................................2486 Substances of animal origin for the production of veterinary
Stanozolol..................................................................................2486 vaccines (5.2.5.)........................................................................ 460
Stanozololum ...........................................................................2486 Sub-visible particles, particulate contamination (2.9.19.).. 253
Star anise...................................................................................2487 Succinylsulfathiazole ..............................................................2498
Star anise oil .............................................................................2488 Succinylsulfathiazolum.........................................................2498
Starch glycolate (type A), sodium ........................................2450 Sucrose.......................................................................................2499
Starch glycolate (type B), sodium ........................................ 2451 Sufentanil .................................................................................. 2501
Starch glycolate (type C), sodium ........................................ 2451 Sufentanil citrate .....................................................................2502
Starch, maize .....................................................................5.1-2965 Sufentanili citras.....................................................................2502
Starch, potato ...........................................................................2288 Sufentanilum............................................................................ 2501
Starch, pregelatinised .............................................................2490 Sugars, lead in (2.4.10.) ............................................................ 107
Starch, rice ................................................................................2369 Sugar spheres ...........................................................................2503
Starch, wheat ............................................................................2698 Sulfacetamide sodium.............................................................2504
Statistical analysis of results of biological assays and tests Sulfacetamidum natricum....................................................2504
(5.3.)............................................................................................ 475 Sulfadiazine...............................................................................2505
Stavudine............................................................................5.1-3012 Sulfadiazinum .........................................................................2505
Stavudinum .......................................................................5.1-3012 Sulfadimidine............................................................................2506
Steam sterilisation of aqueous preparations, application of Sulfadimidinum.......................................................................2506
the F0 concept (5.1.5.)....................................................5.1-2821 Sulfadoxine................................................................................2507
Stearic acid................................................................................2490 Sulfadoxinum...........................................................................2507

3080 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Sulfafurazole.............................................................................2508 Tablets, dispersible .................................................................... 628


Sulfafurazolum ........................................................................2508 Tablets, effervescent .................................................................. 627
Sulfaguanidine..........................................................................2508 Tablets for use in the mouth ................................................... 628
Sulfaguanidinum ....................................................................2508 Tablets for vaginal solutions and suspensions .................... 630
Sulfamerazine...........................................................................2509 Tablets, gastro-resistant............................................................ 628
Sulfamerazinum......................................................................2509 Tablets, modified-release .......................................................... 628
Sulfamethizole.......................................................................... 2510 Tablets, orodispersible .............................................................. 628
Sulfamethizolum ..................................................................... 2510 Tablets, resistance to crushing (2.9.8.) ................................. 235
Sulfamethoxazole .................................................................... 2511 Tablets, soluble........................................................................... 628
Sulfamethoxazolum................................................................ 2511 Tablets, sublingual..................................................................... 613
Sulfamethoxypyridazine for veterinary use ....................... 2512 Tablets, uncoated ....................................................................... 627
Sulfamethoxypyridazinum ad usum veterinarium ....... 2512 Tablets, uncoated, friability of (2.9.7.) ................................... 234
Sulfanilamide ............................................................................ 2513 Tablets, vaginal........................................................................... 629
Sulfanilamidum....................................................................... 2513 Talc....................................................................................... 5.1-3017
Sulfasalazine ............................................................................. 2514 Talcum ................................................................................ 5.1-3017
Sulfasalazinum........................................................................ 2514 Tamoxifen citrate .............................................................. 5.1-3018
Sulfathiazole ............................................................................. 2516 Tamoxifeni citras.............................................................. 5.1-3018
Sulfathiazolum ........................................................................ 2516 Tamponae medicatae ............................................................... 628
Sulfinpyrazone ......................................................................... 2517 Tampons, ear............................................................................... 602
Sulfinpyrazonum .................................................................... 2517 Tampons, medicated ................................................................. 628
Sulfisomidine ............................................................................ 2518 Tampons, rectal .......................................................................... 624
Sulfisomidinum....................................................................... 2518 Tampons, vaginal, medicated .................................................. 630
Sulfur ad usum externum.....................................................2520 Tanaceti parthenii herba ......................................................1592
Sulfuris colloidalis et technetii (99mTc) solutio Tannic acid ................................................................................2534
iniectabilis ................................................................................ 852 Tannins in herbal drugs, determination of (2.8.14.) .......... 221
Sulindac ..................................................................................... 2518 Tanninum .................................................................................2534
Sulindacum .............................................................................. 2518 Tartaric acid ..............................................................................2534
Sulphated ash (2.4.14.) ............................................................. 108 Teat dips....................................................................................... 631
Sulphates (2.4.13.) ..................................................................... 108 Tea tree oil .................................................................................2534
Sulphur dioxide (2.5.29.).......................................................... 136 Teat sprays................................................................................... 631
Sulphur for external use ........................................................2520 Technetii (99mTc) et etifenini solutio iniectabilis............... 853
Sulphuric acid...........................................................................2520 Technetii (99mTc) exametazimi solutio iniectabilis ........... 854
Sulpiride..................................................................................... 2521 Technetii (99mTc) gluconatis solutio iniectabilis................ 856
Sulpiridum................................................................................ 2521 Technetii (99mTc) humani albumini solutio iniectabilis .. 856
Sumatriptani succinas...........................................................2522 Technetii (99mTc) macrosalbi suspensio iniectabilis......... 858
Sumatriptan succinate............................................................2522 Technetii (99mTc) medronati solutio iniectabilis................ 859
Sunflower oil, refined .............................................................2524 Technetii (99mTc) mertiatidi solutio iniectabilis................. 860
Supercritical fluid chromatography (2.2.45.) ........................ 68 Technetii (99mTc) microsphaerarum suspensio
Suppositories .............................................................................. 623 iniectabilis ................................................................................ 861
Suppositories and pessaries, disintegration of (2.9.2.)...... 227 Technetii (99mTc) pentetatis solutio iniectabilis................. 862
Suppositories and pessaries, resistance to rupture Technetii (99mTc) sestamibi solutio iniectabilis.................. 863
(2.9.24.) ...................................................................................... 258 Technetii (99mTc) succimeri solutio iniectabilis................. 865
Suppositories, lipophilic, softening time determination Technetium (99mTc) colloidal rhenium sulphide injection
(2.9.22.) ...................................................................................... 256 ..................................................................................................... 851
Sutures, sterile non-absorbable .............................................. 874 Technetium (99mTc) colloidal sulphur injection ................... 852
Sutures, sterile synthetic absorbable braided .................... 878 Technetium (99mTc) colloidal tin injection ............................ 853
Sutures, sterile synthetic absorbable monofilament ........ 880 Technetium (99mTc) etifenin injection .................................... 853
Suxamethonii chloridum ......................................................2525 Technetium (99mTc) exametazime injection .......................... 854
Suxamethonium chloride.......................................................2525 Technetium (99mTc) gluconate injection ................................ 856
Suxibuzone................................................................................2525 Technetium (99mTc) human albumin injection ..................... 856
Suxibuzonum ...........................................................................2525 Technetium (99mTc) macrosalb injection................................ 858
Sweet fennel..............................................................................1580 Technetium (99mTc) medronate injection............................... 859
Sweet orange oil.......................................................................2526 Technetium (99mTc) mertiatide injection ............................... 860
Swelling index (2.8.4.)............................................................... 215 Technetium (99mTc) microspheres injection.......................... 861
Swine erysipelas vaccine (inactivated) .................................. 793 Technetium (99mTc) pentetate injection................................. 862
Swine-fever vaccine (live), classical, freeze-dried ................ 793 Technetium (99mTc) sestamibi injection ................................. 863
Symbols and abbreviations (1.5.).................................................9 Technetium (99mTc) succimer injection.................................. 865
Synthetic absorbable braided sutures, sterile ..................... 878 Technetium (99mTc) tin pyrophosphate injection................. 865
Synthetic absorbable monofilament sutures, sterile.......... 880 Temazepam................................................................................2535
Syringes, plastic, sterile single-use (3.2.8.)............................314 Temazepamum ........................................................................2535
Syrups........................................................................................... 609 Tenosynovitis avian viral vaccine (live) ................................. 729
Tenoxicam..................................................................................2537
T Tenoxicamum ..........................................................................2537
Table of physical characteristics of radionuclides mentioned Terbutaline sulphate ...............................................................2538
in the European Pharmacopoeia (5.7.) ............................... 539 Terbutalini sulfas ....................................................................2538
Tablets .......................................................................................... 626 Terconazole ...............................................................................2539
Tablets and capsules, disintegration of (2.9.1.) ................... 225 Terconazolum ..........................................................................2539
Tablets, buccal ............................................................................ 613 Terebinthini aetheroleum ab pinum pinastrum .............2645
Tablets, coated............................................................................ 627 Terfenadine................................................................................2540

General Notices (1) apply to all monographs and other texts 3081
Index EUROPEAN PHARMACOPOEIA 5.1

Terfenadinum...........................................................................2540 Thiamphenicol ..........................................................................2562


Terminology used in monographs on vaccines (5.2.1.) ..... 453 Thiamphenicolum...................................................................2562
tert-Butylamini perindoprilum............................................ 2210 Thin-layer chromatography (2.2.27.)........................................ 40
Test for anticomplementary activity of immunoglobulin Thiomersal..........................................................................5.1-3021
(2.6.17.)....................................................................................... 170 Thiomersalum...................................................................5.1-3021
Test for deliverable mass or volume of liquid and semi-solid Thiopental sodium and sodium carbonate.........................2564
preparations (2.9.28.).............................................................. 263 Thiopentalum natricum et natrii carbonas .....................2564
Test for extractable volume of parenteral preparations Thioridazine ..............................................................................2565
(2.9.17.)....................................................................................... 243 Thioridazine hydrochloride ...................................................2566
Test for Fc function of immunoglobulin (2.7.9.) ................. 202 Thioridazini hydrochloridum..............................................2566
Test for methanol and 2-propanol (2.9.11.) .......................... 239 Thioridazinum.........................................................................2565
Test for neurovirulence of live virus vaccines (2.6.18.) ..... 172 Three-lobed sage leaf...............................................................2390
Test for neurovirulence of poliomyelitis vaccine (oral) Threonine...................................................................................2566
(2.6.19.) ...................................................................................... 172 Threoninum..............................................................................2566
Testosterone..............................................................................2542 Thyme .........................................................................................2567
Testosterone enantate.............................................................2544 Thyme oil ..................................................................................2569
Testosterone propionate.........................................................2545 Thyme, wild ............................................................................... 2701
Testosteroni enantas ..............................................................2544 Thymi aetheroleum ................................................................2569
Testosteroni propionas ..........................................................2545 Thymi herba .............................................................................2567
Testosteronum..........................................................................2542 Thymol........................................................................................2570
Tests for extraneous agents in viral vaccines for human use Thymolum .................................................................................2570
(2.6.16.) ...................................................................................... 169 Tiabendazole .............................................................................2570
Tetanus antitoxin for human use ........................................... 805 Tiabendazolum ........................................................................2570
Tetanus antitoxin for veterinary use.............................5.1-2868 Tiamulin for veterinary use ...................................................2571
Tetanus, diphtheria and hepatitis B (rDNA) vaccine Tiamulin hydrogen fumarate for veterinary use ...............2573
(adsorbed).................................................................................. 641 Tiamulini hydrogenofumaras ad usum veterinarium ..2573
Tetanus, diphtheria, pertussis (acellular, component), Tiamulinum ad usum veterinarium ..................................2571
poliomyelitis (inactivated) and haemophilus type b Tianeptine sodium ...................................................................2575
conjugate vaccine (adsorbed)................................................ 653 Tianeptinum natricum ..........................................................2575
Tetanus, diphtheria, pertussis and poliomyelitis (inactivated) Tiapride hydrochloride ...........................................................2577
vaccine (adsorbed)................................................................... 656 Tiapridi hydrochloridum ......................................................2577
Tetanus, diphtheria, pertussis, poliomyelitis (inactivated) and Tiaprofenic acid ........................................................................2578
haemophilus type b conjugate vaccine (adsorbed) .......... 657 Ticarcillin sodium..............................................................5.1-3021
Tetanus immunoglobulin, human ........................................ 1751 Ticarcillinum natricum ..................................................5.1-3021
Tetanus vaccine (adsorbed) ..................................................... 702 Tick-borne encephalitis vaccine (inactivated) ...................... 703
Tetanus vaccine (adsorbed), assay of (2.7.8.) ..............5.1-2791 Ticlopidine hydrochloride ...................................................... 2581
Tetanus vaccine for veterinary use ........................................ 795 Ticlopidini hydrochloridum................................................. 2581
Tetracaine hydrochloride .......................................................2546 Tiliae flos................................................................................... 1914
Tetracaini hydrochloridum ..................................................2546 Tilidine hydrochloride hemihydrate ....................................2582
Tetracosactide...........................................................................2547 Tilidini hydrochloridum hemihydricum...........................2582
Tetracosactidum ......................................................................2547 Timololi maleas .......................................................................2584
Tetracycline ...............................................................................2549 Timolol maleate ........................................................................2584
Tetracycline hydrochloride .................................................... 2551 Tincturae ..................................................................................... 571
Tetracyclini hydrochloridum ............................................... 2551 Tincturae maternae
Tetracyclinum ..........................................................................2549 ad praeparationes homoeopathicas................................... 894
Tetrazepam ................................................................................2552 Tinctures ...................................................................................... 571
Tetrazepamum .........................................................................2552 Tinidazole ..................................................................................2585
Tetryzoline hydrochloride...............................................5.1-3020 Tinidazolum .............................................................................2585
Tetryzolini hydrochloridum..........................................5.1-3020 Tinnevelly senna pods.............................................................2405
Thallosi (201Tl) chloridi solutio iniectabilis......................... 867 Tinzaparin sodium ...................................................................2586
Thallous (201Tl) chloride injection........................................... 867 Tinzaparinum natricum .......................................................2586
Theobromine.............................................................................2554 Tioconazole ...............................................................................2586
Theobrominum ........................................................................2554 Tioconazolum ..........................................................................2586
Theophylline .............................................................................2554 Titanii dioxidum......................................................................2587
Theophylline-ethylenediamine ..............................................2557 Titanium dioxide ......................................................................2587
Theophylline-ethylenediamine hydrate ...............................2557 Titration, amperometric (2.2.19.).............................................. 34
Theophylline monohydrate....................................................2555 Titration, potentiometric (2.2.20.)............................................ 35
Theophyllinum.........................................................................2554 Titrations, complexometric (2.5.11.) ...................................... 130
Theophyllinum et ethylenediaminum ...............................2557 Tobramycin ................................................................................2588
Theophyllinum et ethylenediaminum hydricum............2557 Tobramycinum.........................................................................2588
Theophyllinum monohydricum ..........................................2555 α-Tocopherol acetate concentrate (powder form) ............2592
Thermal analysis (2.2.34.). ......................................................... 52 Tocopherol, all-rac-α- .......................................................5.1-3023
Thermogravimetry (2.2.34.)....................................................... 52 α-Tocopheroli acetatis pulvis ...............................................2592
Thiamazole ................................................................................2558 Tocopherol, RRR-α- ................................................................. 2591
Thiamazolum ...........................................................................2558 Tocopheryl acetate, all-rac-α- .........................................5.1-3024
Thiamine hydrochloride .........................................................2559 Tocopheryl acetate, RRR-α-...................................................2595
Thiamine nitrate....................................................................... 2561 Tocopheryl hydrogen succinate, DL-α- ................................2597
Thiamini hydrochloridum ....................................................2559 Tocopheryl hydrogen succinate, RRR-α- .....................5.1-3026
Thiamini nitras........................................................................ 2561 Tolbutamide ..............................................................................2600

3082 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Tolbutamidum..........................................................................2600 Tri-n-butyl phosphate .............................................................. 2631


Tolfenamic acid......................................................................... 2601 Tritiated (3H) water injection................................................... 867
Tolnaftate ..................................................................................2602 Tritici aestivi oleum raffinatum ..........................................2699
Tolnaftatum ..............................................................................2602 Tritici aestivi oleum virginale..............................................2699
Tolu balsam ...............................................................................2603 Tritici amylum .........................................................................2698
Tormentil ...................................................................................2604 Trolamine...................................................................................2632
Tormentillae rhizoma ............................................................2604 Trolaminum..............................................................................2632
Tormentillae tinctura .............................................................2605 Trometamol ...............................................................................2633
Tormentil tincture....................................................................2605 Trometamolum ........................................................................2633
Tosylchloramide sodium.........................................................2605 Tropicamide...............................................................................2634
Tosylchloramidum natricum ...............................................2605 Tropicamidum .........................................................................2634
Total ash (2.4.16.)....................................................................... 108 Trypsin .......................................................................................2635
Total organic carbon in water for pharmaceutical use Trypsinum.................................................................................2635
(2.2.44.) ........................................................................................ 68 Tryptophan................................................................................2636
Total protein (2.5.33.) ............................................................... 138 Tryptophanum .........................................................................2636
Toxicity, abnormal (2.6.9.)........................................................ 153 Tuberculin for human use, old..............................................2638
Toxin, botulinum type A for injection...................................1117 Tuberculini aviarii derivatum proteinosum
Toxinum botulinicum typum A ad iniectabile .................1117 purificatum.............................................................................2640
Tragacanth ................................................................................2606 Tuberculini bovini derivatum proteinosum
Tragacantha..............................................................................2606 purificatum............................................................................. 2641
Tramadol hydrochloride .........................................................2607 Tuberculini derivatum proteinosum purificatum ad usum
Tramadoli hydrochloridum ..................................................2607 humanum ...............................................................................2642
Tramazoline hydrochloride monohydrate ..........................2608 Tuberculin purified protein derivative, avian ....................2640
Tramazolini hydrochloridum monohydricum ................2608 Tuberculin purified protein derivative, bovine.................. 2641
Tranexamic acid .......................................................................2609 Tuberculin purified protein derivative for human use ....2642
Transdermal patches ..................................................................616 Tuberculinum pristinum ad usum humanum ................2638
Transdermal patches, dissolution test for (2.9.4.) .............. 231 Tubes for comparative tests (2.1.5.) ..........................................19
Trapidil ....................................................................................... 2610 Tubing and closures, silicone elastomer for (3.1.9.)........... 288
Trapidilum ................................................................................ 2610 Tubing and containers for total parenteral nutrition
Tretinoin .................................................................................... 2611 preparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285
Tretinoinum.............................................................................. 2611 Tubing used in sets for the transfusion of blood and blood
Triacetin ..................................................................................... 2612 components, materials based on plasticised poly(vinyl
Triacetinum .............................................................................. 2612 chloride) for (3.1.1.2.) ............................................................. 272
Triamcinolone........................................................................... 2613 Tubocurarine chloride ............................................................2644
Triamcinolone acetonide........................................................ 2614 Tubocurarini chloridum........................................................2644
Triamcinolone hexacetonide ................................................. 2616 Turmeric, javanese...................................................................2645
Triamcinoloni acetonidum................................................... 2614 Turpentine oil, Pinus pinaster type .....................................2645
Triamcinoloni hexacetonidum............................................ 2616 Tylosin for veterinary use ......................................................2647
Triamcinolonum ..................................................................... 2613 Tylosini phosphatis solutio ad usum veterinarium .......2648
Triamterene ............................................................................... 2617 Tylosini tartras ad usum veterinarium .............................2650
Triamterenum .......................................................................... 2617 Tylosin phosphate bulk solution for veterinary use ........2648
Tribenoside................................................................................ 2617 Tylosin tartrate for veterinary use .......................................2650
Tribenosidum ........................................................................... 2617 Tylosinum ad usum veterinarium......................................2647
Tributyl acetylcitrate ............................................................... 2619 Typhoid polysaccharide vaccine ............................................. 705
Tributylis acetylcitras............................................................. 2619 Typhoid vaccine.......................................................................... 707
Tricalcii phosphas................................................................... 1167 Typhoid vaccine, freeze-dried.................................................. 707
Trichloroacetic acid .................................................................2620 Typhoid vaccine (live, oral, strain Ty 21a)............................ 708
Triethanolamine .......................................................................2632 Tyrosine...................................................................................... 2651
Triethyl citrate ..........................................................................2620 Tyrosinum................................................................................. 2651
Triethylis citras ........................................................................2620 Tyrothricin..........................................................................5.1-3028
Trifluoperazine hydrochloride .............................................. 2621 Tyrothricinum...................................................................5.1-3028
Trifluoperazini hydrochloridum......................................... 2621
Triflusal ......................................................................................2622 U
Triflusalum ...............................................................................2622 Ubidecarenone..........................................................................2657
Triglycerida saturata media.................................................2623 Ubidecarenonum.....................................................................2657
Triglycerides, medium-chain..................................................2623 Udder-washes .............................................................................. 631
Triglycerides, omega-3-acid.................................................... 2144 Ultraviolet absorption spectrophotometry (2.2.25.)............. 38
Trigonellae foenugraeci semen...........................................1588 Ultraviolet ray lamps for analytical purposes (2.1.3.)............17
Trihexyphenidyl hydrochloride.............................................2625 Uncoated tablets......................................................................... 627
Trihexyphenidyli hydrochloridum .....................................2625 Undecylenic acid ......................................................................2658
Trimetazidine dihydrochloride..............................................2626 Uniformity of content of single-dose preparations
Trimetazidini dihydrochloridum........................................2626 (2.9.6.) ........................................................................................ 234
Trimethadione ..........................................................................2627 Uniformity of mass of delivered doses from multidose
Trimethadionum .....................................................................2627 containers (2.9.27.).................................................................. 263
Trimethoprim............................................................................2628 Uniformity of mass of single-dose preparations (2.9.5.) .... 233
Trimethoprimum.....................................................................2628 Units of the International System (SI) used in the
Trimipramine maleate.............................................................2630 Pharmacopoeia and equivalence with other units (1.6.) ...10
Trimipramini maleas .............................................................2630 Unsaponifiable matter (2.5.7.) ................................................. 129
Tri-n-butylis phosphas............................................................ 2631 Urea.............................................................................................2658

General Notices (1) apply to all monographs and other texts 3083
Index EUROPEAN PHARMACOPOEIA 5.1

Ureum.........................................................................................2658 Vaccinum clostridii septici ad usum veterinarium.......... 749


Urofollitropin ............................................................................2659 Vaccinum colibacillosis fetus a partu recentis inactivatum
Urofollitropinum .....................................................................2659 ad ruminantes ......................................................................... 778
Urokinase................................................................................... 2661 Vaccinum colibacillosis fetus a partu recentis inactivatum
Urokinasum .............................................................................. 2661 ad suem ..................................................................................... 776
Uronic acids in polysaccharide vaccines (2.5.22.)............... 133 Vaccinum diarrhoeae viralis bovinae inactivatum .......... 734
Ursodeoxycholic acid .............................................................2662 Vaccinum diphtheriae adsorbatum ...................................... 660
Urtica dioica ad praeparationes homoeopathicas ........... 895 Vaccinum diphtheriae adulti et adulescentis
Urticae folium ...................................................................5.1-2980 adsorbatum............................................................................... 661
Uvae ursi folium ...................................................................... 1054 Vaccinum diphtheriae et tetani adsorbatum ..................... 639
Vaccinum diphtheriae et tetani adulti et adulescentis
V adsorbatum............................................................................... 639
Vaccina ad usum humanum .........................................5.1-2835 Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)
Vaccina ad usum veterinarium ............................................. 590 adsorbatum............................................................................... 641
Vaccines, adsorbed, aluminium in (2.5.13.)...........................131 Vaccinum diphtheriae, tetani et pertussis adsorbatum .. 643
Vaccines, adsorbed, calcium in (2.5.14.).................................131 Vaccinum diphtheriae, tetani et pertussis sine cellulis ex
Vaccines and immunosera, phenol in (2.5.15.).....................131 elementis praeparatum adsorbatum.................................. 642
Vaccines and immunosera, veterinary, evaluation of efficacy Vaccinum diphtheriae, tetani, pertussis et poliomyelitidis
(5.2.7.)................................................................................5.1-2829 inactivatum adsorbatum....................................................... 656
Vaccines and immunosera, veterinary, evaluation of safety Vaccinum diphtheriae, tetani, pertussis, poliomyelitidis
(5.2.6.) ...............................................................................5.1-2827 inactivatum et haemophili stirpe b coniugatum
Vaccines and immunosera, veterinary, evaluation of the adsorbatum............................................................................... 657
safety of each batch (5.2.9.)..........................................5.1-2830 Vaccinum diphtheriae, tetani, pertussis sine cellulis ex
Vaccines for human use...................................................5.1-2835 elementis praeparatum et haemophili stirpe b coniugatum
Vaccines for human use, cell substrates for the production of adsorbatum............................................................................... 645
(5.2.3.) ........................................................................................ 455 Vaccinum diphtheriae, tetani, pertussis sine cellulis
Vaccines for human use, viral, extraneous agents in ex elementis praeparatum et hepatitidis B (ADNr)
(2.6.16.) ...................................................................................... 169 adsorbatum............................................................................... 647
Vaccines for veterinary use...................................................... 590 Vaccinum diphtheriae, tetani, pertussis sine cellulis ex
Vaccines, polysaccharide, hexosamines in (2.5.20.)............ 132 elementis praeparatum et poliomyelitidis inactivatum
Vaccines, polysaccharide, methylpentoses in (2.5.21.)....... 133 adsorbatum............................................................................... 648
Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............ 132 Vaccinum diphtheriae, tetani, pertussis sine cellulis
Vaccines, polysaccharide, O-acetyl in (2.5.19.)..................... 132 ex elementis praeparatum, hepatitidis B (ADNr),
Vaccines, polysaccharide, phosphorus in (2.5.18.) ............. 132 poliomyelitidis inactivatum et haemophili stirpe b
Vaccines, polysaccharide, protein in (2.5.16.) .......................131 coniugatum adsorbatum....................................................... 650
Vaccines, polysaccharide, ribose in (2.5.31.) ........................ 137 Vaccinum diphtheriae, tetani, pertussis sine cellulis ex
Vaccines, polysaccharide, sialic acid in (2.5.23.) ................. 133 elementis praeparatum poliomyelitidis inactivatum et
Vaccines, polysaccharide, uronic acids in (2.5.22.)............. 133 haemophili stirpe b coniugatum adsorbatum................. 653
Vaccines, SPF chicken flocks for the production and quality Vaccinum encephalitidis ixodibus advectae
control of (5.2.2.) ...........................................................5.1-2825 inactivatum .............................................................................. 703
Vaccines, terminology (5.2.1.) ................................................. 453 Vaccinum encephalomyelitidis infectivae aviariae
Vaccines, veterinary, cell cultures for the production of vivum.......................................................................................... 725
(5.2.4.) ........................................................................................ 458 Vaccinum erysipelatis suillae inactivatum ........................ 793
Vaccines, veterinary, substances of animal origin for the Vaccinum febris flavae vivum.......................................5.1-2852
production of (5.2.5.) .............................................................. 460 Vaccinum febris typhoidi ........................................................ 707
Vaccines, viral live, test for neurovirulence (2.6.18.).......... 172 Vaccinum febris typhoidi cryodesiccatum ......................... 707
Vaccinum actinobacillosis inactivatum ad suem ............. 784 Vaccinum febris typhoidis polysaccharidicum ................. 705
Vaccinum adenovirosidis caninae vivum........................... 738 Vaccinum febris typhoidis vivum perorale (stirpe
Vaccinum adenovirosis caninae inactivatum ................... 738 Ty 21a) ....................................................................................... 708
Vaccinum anaemiae infectivae pulli vivum....................... 769 Vaccinum furunculosidis ad salmonidas inactivatum cum
Vaccinum anthracis vivum ad usum veterinarium.......... 715 adiuvatione oleosa ad iniectionem.................................... 767
Vaccinum aphtharum epizooticarum inactivatum ad Vaccinum haemophili stirpe b coniugatum....................... 662
ruminantes ......................................................................5.1-2860 Vaccinum hepatitidis A inactivatum adsorbatum ............ 665
Vaccinum bronchitidis infectivae aviariae inactivatum.. 718 Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)
Vaccinum bronchitidis infectivae aviariae vivum............ 720 adsorbatum............................................................................... 664
Vaccinum brucellosis (Brucella melitensis stirpe Rev. 1) Vaccinum hepatitidis A inactivatum virosomale.............. 667
vivum cryodesiccatum ad usum veterinarium ......5.1-2859 Vaccinum hepatitidis B (ADNr)............................................. 670
Vaccinum bursitidis infectivae aviariae inactivatum...... 722 Vaccinum hepatitidis viralis anatis stirpe I vivum .......... 751
Vaccinum bursitidis infectivae aviariae vivum................. 723 Vaccinum herpesviris equini inactivatum ......................... 754
Vaccinum calicivirosis felinae inactivatum ....................... 757 Vaccinum inactivatum diarrhoeae vituli coronaviro
Vaccinum calicivirosis felinae vivum cryodesiccatum ... 758 illatae ......................................................................................... 736
Vaccinum cholerae ................................................................... 637 Vaccinum inactivatum diarrhoeae vituli rotaviro
Vaccinum cholerae aviariae inactivatum..................5.1-2861 illatae ......................................................................................... 737
Vaccinum cholerae cryodesiccatum..................................... 638 Vaccinum influenzae equi inactivatum.............................. 755
Vaccinum clostridii botulini ad usum veterinarium ....... 745 Vaccinum influenzae inactivatum ad suem ...................... 785
Vaccinum clostridii chauvoei ad usum veterinarium ..... 745 Vaccinum influenzae inactivatum ex corticis antigeniis
Vaccinum clostridii novyi B ad usum veterinarium ....... 746 praeparatum............................................................................. 673
Vaccinum clostridii perfringentis Vaccinum influenzae inactivatum ex corticis antigeniis
ad usum veterinarium........................................................... 747 praeparatum virosomale....................................................... 674

3084 See the information section on general monographs (cover pages)


EUROPEAN PHARMACOPOEIA 5.1 Index

Vaccinum influenzae inactivatum ex viris integris Vaccinum variolae gallinaceae vivum ............................... 766
praeparatum............................................................................. 676 Vaccinum vibriosidis ad salmonidas inactivatum ........... 797
Vaccinum influenzae inactivatum ex virorum fragmentis Vaccinum vibriosidis aquae frigidae inactivatum ad
praeparatum............................................................................. 671 salmonidas................................................................................ 796
Vaccinum laryngotracheitidis infectivae aviariae Vaccinum viri syncytialis meatus spiritus bovini vivum
vivum.......................................................................................... 727 cryodesiccatum ....................................................................... 733
Vaccinum leptospirosis bovinae inactivatum.................... 730 Vaginal capsules ......................................................................... 629
Vaccinum leptospirosis caninae inactivatum ................... 740 Vaginal foams.............................................................................. 630
Vaccinum leucosis felinae inactivatum................................761 Vaginalia ..................................................................................... 629
Vaccinum mannheimiae inactivatum ad bovidas ............ 771 Vaginal preparations ................................................................. 629
Vaccinum mannheimiae inactivatum ad ovem ................ 772 Vaginal preparations, semi-solid ............................................. 630
Vaccinum meningococcale classis C coniugatum ........... 680 Vaginal solutions and suspensions, tablets for.................... 630
Vaccinum meningococcale polysaccharidicum................ 682 Vaginal solutions, emulsions and suspensions.................... 630
Vaccinum morbi Aujeszkyi ad suem inactivatum ............ 715 Vaginal tablets ............................................................................ 629
Vaccinum morbi Aujeszkyi ad suem vivum cryodesiccatum Vaginal tampons, medicated.................................................... 630
ad usum parenterale ...............................................................717 Valerianae radix ......................................................................2667
Vaccinum morbi Carrei vivum cryodesiccatum ad canem Valerian root..............................................................................2667
..................................................................................................... 740 Validation of nucleic acid amplification techniques for the
Vaccinum morbi Carrei vivum cryodesiccatum ad detection of hepatitis C virus (HCV) RNA in plasma pools :
mustelidas................................................................................. 751 Guidelines...................................................................................176
Vaccinum morbillorum, parotitidis et rubellae vivum.... 678 Valine ..........................................................................................2668
Vaccinum morbillorum vivum............................................... 679 Valinum .....................................................................................2668
Vaccinum morbi Marek vivum .............................................. 774 Valproic acid..............................................................................2669
Vaccinum morbi partus diminutionis MCMLXXVI Vancomycin hydrochloride ....................................................2670
inactivatum ad pullum .......................................................... 753 Vancomycini hydrochloridum .............................................2670
Vaccinum myxomatosidis vivum ad cuniculum ............... 775 Vanillin .......................................................................................2672
Vaccinum panleucopeniae felinae infectivae Vanillinum ................................................................................2672
inactivatum .............................................................................. 759 Varicella immunoglobulin for intravenous administration,
Vaccinum panleucopeniae felinae infectivae vivum....... 760 human ...................................................................................... 1753
Vaccinum parainfluenzae viri bovini vivum Varicella immunoglobulin, human ....................................... 1752
cryodesiccatum ....................................................................... 732 Varicella vaccine (live)............................................................... 709
Vaccinum parainfluenzae viri canini vivum..................... 742 Vaselinum album..................................................................... 2187
Vaccinum paramyxoviris 3 aviarii inactivatum ............... 728 Vaselinum flavum ................................................................... 2188
Vaccinum parotitidis vivum ................................................... 684 Vegetable drugs, determination of essential oils in vegetable
Vaccinum parvovirosis caninae inactivatum .................... 743 drugs (2.8.12.) ...........................................................................217
Vaccinum parvovirosis caninae vivum ............................... 744 Vegetable fatty oils..................................................................... 595
Vaccinum parvovirosis inactivatum ad suem ................... 787 Verapamil hydrochloride ........................................................2673
Vaccinum pasteurellae inactivatum ad ovem.................... 783 Verapamili hydrochloridum .................................................2673
Vaccinum pertussis................................................................... 685 Verbasci flos..............................................................................2065
Vaccinum pertussis adsorbatum ........................................... 690 Veterinary liquid preparations for cutaneous application.. 630
Vaccinum pertussis sine cellulis copurificatum Vibriosis (cold-water) vaccine (inactivated) for salmonids.. 796
adsorbatum............................................................................... 688 Vibriosis vaccine (inactivated) for salmonids....................... 797
Vaccinum pertussis sine cellulis ex elementis praeparatum VICH (5.8.)................................................................................... 551
adsorbatum............................................................................... 686 Vinblastine sulphate................................................................2675
Vaccinum pestis classicae suillae vivum Vinblastini sulfas.....................................................................2675
cryodesiccatum ....................................................................... 793 Vincristine sulphate.................................................................2675
Vaccinum pneumococcale polysaccharidicum................. 691 Vincristini sulfas .....................................................................2675
Vaccinum pneumococcale polysaccharidicum coniugatum Vindesine sulphate ..................................................................2677
adsorbatum......................................................................5.1-2851 Vindesini sulfas .......................................................................2677
Vaccinum poliomyelitidis inactivatum ............................... 692 Vinorelbine tartrate ..........................................................5.1-3033
Vaccinum poliomyelitidis perorale ...................................... 695 Vinorelbini tartras............................................................5.1-3033
Vaccinum pseudopestis aviariae inactivatum................... 779 Violae herba cum flore ..........................................................2700
Vaccinum pseudopestis aviariae vivum .............................. 781 Viper venom antiserum, European ........................................ 806
Vaccinum rabiei ex cellulis ad usum humanum .............. 699 Viscometer method, capillary (2.2.9.)...................................... 29
Vaccinum rabiei inactivatum ad usum veterinarium ..... 790 Viscometer method, falling ball (2.2.49.)................................ 80
Vaccinum rabiei perorale vivum ad vulpem ...................... 792 Viscometer method, rotating (2.2.10.)..................................... 30
Vaccinum rhinitidis atrophicantis ingravescentis suillae Viscose wadding, absorbent .................................................. 2681
inactivatum .............................................................................. 788 Viscosity (2.2.8.) ........................................................................... 29
Vaccinum rhinotracheitidis infectivae bovinae vivum Visible absorption spectrophotometry (2.2.25.).................... 38
cryodesiccatum ....................................................................... 768 Visible particles, particulate contamination (2.9.20.) ........ 255
Vaccinum rhinotracheitidis viralis felinae inactivatum.. 762 Vitamin A ...................................................................................2682
Vaccinum rhinotracheitidis viralis felinae vivum Vitamin A concentrate (oily form), synthetic.....................2684
cryodesiccatum ....................................................................... 763 Vitamin A concentrate (powder form), synthetic..............2685
Vaccinum rubellae vivum ....................................................... 701 Vitamin A concentrate (solubilisate/emulsion),
Vaccinum tenosynovitidis viralis aviariae vivum ............ 729 synthetic ..................................................................................2686
Vaccinum tetani adsorbatum ................................................. 702 Vitaminum A ............................................................................2682
Vaccinum tetani ad usum veterinarium ............................. 795 Vitaminum A densatum oleosum .......................................2684
Vaccinum tuberculosis (BCG) cryodesiccatum ................. 636 Vitaminum A in aqua dispergibile .....................................2686
Vaccinum varicellae vivum .................................................... 709 Vitaminum A pulvis................................................................2685

General Notices (1) apply to all monographs and other texts 3085
Index EUROPEAN PHARMACOPOEIA 5.1

Volumetric analysis (4.2.) ......................................................... 435 X-ray fluorescence spectrometry (2.2.37.)............................... 56


Volumetric solutions (4.2.2.).................................................... 435 Xylazine hydrochloride for veterinary use ......................... 2716
Volumetric solutions, primary standards for (4.2.1.) ......... 435 Xylazini hydrochloridum ad usum veterinarium .......... 2716
Von Willebrand factor, human, assay of (2.7.21.).................211 Xylitol.......................................................................................... 2717
Xylitolum ................................................................................... 2717
W Xylometazoline hydrochloride .............................................. 2719
Warfarin sodium....................................................................... 2691 Xylometazolini hydrochloridum ......................................... 2719
Warfarin sodium clathrate ..................................................... 2691 Xylose..........................................................................................2720
Warfarinum natricum............................................................ 2691 Xylosum .....................................................................................2720
Warfarinum natricum clathratum...................................... 2691
Water (15O) injection.................................................................. 868 Y
Water, determination by distillation (2.2.13.) ........................ 32 Yarrow ........................................................................................2723
Water for diluting concentrated haemodialysis Yellow beeswax ......................................................................... 1058
solutions .................................................................................. 1699 Yellow fever vaccine (live) ...............................................5.1-2852
Water for injections .................................................................2692 Yellow soft paraffin.................................................................. 2188
Water for pharmaceutical use, total organic carbon in
(2.2.44.) ........................................................................................ 68 Z
Water, highly purified .............................................................2695 Zidovudine..........................................................................5.1-3043
Water in essential oils (2.8.5.) ..................................................216 Zidovudinum .....................................................................5.1-3043
Water in gases (2.5.28.) ............................................................ 136 Zinc acetate dihydrate.............................................................2728
Water: micro determination (2.5.32.) .................................... 137 Zinc acexamate .........................................................................2729
Water, purified..........................................................................2697 Zinc chloride .............................................................................2730
Water: semi-micro determination (2.5.12.)........................... 130 Zinci acetas dihydricus .........................................................2728
Wheat-germ oil, refined ..........................................................2699 Zinci acexamas........................................................................2729
Wheat-germ oil, virgin.............................................................2699 Zinci chloridum.......................................................................2730
Wheat starch .............................................................................2698 Zinci oxidum ............................................................................ 2731
White beeswax .......................................................................... 1057 Zinci stearas .............................................................................2732
White horehound..............................................................5.1-3039 Zinci sulfas heptahydricus....................................................2732
White soft paraffin................................................................... 2187 Zinci sulfas hexahydricus .....................................................2733
Wild pansy (flowering aerial parts)......................................2700 Zinci undecylenas...................................................................2733
Wild thyme ................................................................................ 2701 Zinc oxide................................................................................... 2731
Willow bark ...............................................................................2702 Zinc stearate..............................................................................2732
Wool alcohols............................................................................2703 Zinc sulphate heptahydrate ...................................................2732
Wool fat ......................................................................................2704 Zinc sulphate hexahydrate.....................................................2733
Wool fat, hydrogenated...........................................................2708 Zinc undecylenate ....................................................................2733
Wool fat, hydrous.....................................................................2709 Zingiberis rhizoma ................................................................. 1656
Wormwood ................................................................................ 2710 Zolpidemi tartras.....................................................................2734
Zolpidem tartrate .....................................................................2734
X Zopiclone ...................................................................................2735
Xanthan gum ............................................................................ 2715 Zopiclonum...............................................................................2735
Xanthani gummi ..................................................................... 2715 Zuclopenthixol decanoate ......................................................2736
Xenon (133Xe) injection.............................................................. 869 Zuclopenthixoli decanoas.....................................................2736
Xenoni (133Xe) solutio iniectabilis ......................................... 869

3086 See the information section on general monographs (cover pages)