EUROPEAN PHARMACOPOEIA 7.0 INDEX Monographs deleted from the 6 th Edition are not included in the index; a list of deleted texts is found in the Contents of Volume 1, page xxii. English index ........................................................................ 3267 Latin index ................................................................................. 3295 General Notices (1) apply to all monographs and other texts 3265
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EUROPEAN PHARMACOPOEIA 7.0
INDEXMonographs deleted from the 6th Edition are not included in the index; a list of deleted texts is found in the Contents ofVolume 1, page xxii.
English index ........................................................................ 3267 Latin index ................................................................................. 3295
General Notices (1) apply to all monographs and other texts 3265
EUROPEAN PHARMACOPOEIA 7.0
3266 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.0 Index
Numerics1. General notices .................................................................................32.1.1. Droppers ................................................................................... 152.1.2. Comparative table of porosity of sintered-glass filters ... 152.1.3. Ultraviolet ray lamps for analytical purposes................... 152.1.4. Sieves .........................................................................................162.1.5. Tubes for comparative tests ..................................................172.1.6. Gas detector tubes...................................................................172.1. Apparatus .................................................................................... 152.2.10. Viscosity - Rotating viscometer method.......................... 282.2.11. Distillation range .................................................................. 302.2.12. Boiling point ..........................................................................312.2.13. Determination of water by distillation..............................312.2.14. Melting point - capillary method........................................312.2.15. Melting point - open capillary method ............................ 322.2.16. Melting point - instantaneous method ............................ 322.2.17. Drop point .............................................................................. 322.2.18. Freezing point....................................................................... 342.2.19. Amperometric titration ....................................................... 342.2.1. Clarity and degree of opalescence of liquids.....................212.2.20. Potentiometric titration ...................................................... 342.2.21. Fluorimetry............................................................................ 352.2.22. Atomic emission spectrometry .......................................... 352.2.23. Atomic absorption spectrometry ...................................... 362.2.24. Absorption spectrophotometry, infrared ........................ 382.2.25. Absorption spectrophotometry, ultraviolet andvisible.................................................................................................. 40
2.2.26. Paper chromatography ........................................................412.2.27. Thin-layer chromatography ................................................ 422.2.28. Gas chromatography ........................................................... 432.2.29. Liquid chromatography ...................................................... 452.2.2. Degree of coloration of liquids............................................ 222.2.30. Size-exclusion chromatography ........................................ 462.2.31. Electrophoresis ..................................................................... 462.2.31. Electrophoresis (5.8.)......................................................... 6212.2.32. Loss on drying .......................................................................512.2.33. Nuclear magnetic resonance spectrometry .................... 522.2.34. Thermal analysis................................................................... 542.2.35. Osmolality .............................................................................. 572.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes............................. 57
2.2.37. X-ray fluorescence spectrometry....................................... 582.2.38. Conductivity .......................................................................... 592.2.39. Molecular mass distribution in dextrans ........................ 602.2.3. Potentiometric determination of pH.................................. 242.2.40. Near-infrared spectrophotometry ......................................612.2.41. Circular dichroism................................................................ 652.2.42. Density of solids ................................................................... 662.2.43. Mass spectrometry ............................................................... 672.2.44. Total organic carbon in water for pharmaceuticaluse....................................................................................................... 69
2.2.45. Supercritical fluid chromatography................................. 702.2.46. Chromatographic separation techniques........................ 702.2.47. Capillary electrophoresis .................................................... 772.2.47. Capillary electrophoresis (5.8.)........................................ 6212.2.48. Raman spectrometry ........................................................... 822.2.49. Falling ball viscometer method......................................... 832.2.4. Relationship between reaction of solution, approximate pHand colour of certain indicators ................................................... 25
2.2.58. Inductively coupled plasma-mass spectrometry ............ 962.2.59. Glycan analysis of glycoproteins....................................... 972.2.5. Relative density....................................................................... 252.2.60. Melting point - instrumental method............................. 1022.2.6. Refractive index ...................................................................... 26
2.2.7. Optical rotation ....................................................................... 262.2.8. Viscosity.................................................................................... 272.2.9. Capillary viscometer method ............................................... 272.2. Physical and physicochemical methods.................................212.3.1. Identification reactions of ions and functional groups.. 1072.3.2. Identification of fatty oils by thin-layer chromato-graphy .............................................................................................. 110
2.3.3. Identification of phenothiazines by thin-layerchromatography............................................................................. 110
2.3.4. Odour ...................................................................................... 1102.3. Identification............................................................................. 1072.4.10. Lead in sugars......................................................................1172.4.11. Phosphates............................................................................1172.4.12. Potassium..............................................................................1172.4.13. Sulfates................................................................................. 1182.4.14. Sulfated ash......................................................................... 1182.4.14. Sulfated ash (5.8.) .............................................................. 6222.4.15. Nickel in polyols ................................................................. 1182.4.16. Total ash............................................................................... 1182.4.17. Aluminium............................................................................ 1182.4.18. Free formaldehyde ............................................................. 1182.4.19. Alkaline impurities in fatty oils ....................................... 1192.4.1. Ammonium............................................................................. 1132.4.21. Foreign oils in fatty oils by thin-layer chromato-graphy .............................................................................................. 119
2.4.22. Composition of fatty acids by gas chromatography ... 1192.4.23. Sterols in fatty oils ............................................................. 1212.4.24. Identification and control of residual solvents............ 1232.4.25. Ethylene oxide and dioxan............................................... 1272.4.26. N,N-Dimethylaniline .......................................................... 1282.4.27. Heavy metals in herbal drugs and fatty oils ................. 1292.4.28. 2-Ethylhexanoic acid ......................................................... 1302.4.29. Composition of fatty acids in oils rich in omega-3acids.................................................................................................. 130
2.4.2. Arsenic .................................................................................... 1132.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ....................................................................................... 132
2.4.31. Nickel in hydrogenated vegetable oils ........................... 1322.4.32. Total cholesterol in oils rich in omega-3 acids ............ 1332.4.3. Calcium................................................................................... 1132.4.4. Chlorides ................................................................................ 1132.4.5. Fluorides .................................................................................1142.4.6. Magnesium..............................................................................1142.4.7. Magnesium and alkaline-earth metals ..............................1142.4.8. Heavy metals ..........................................................................1142.4.9. Iron ...........................................................................................1172.4. Limit tests .................................................................................. 1132.5.10. Oxygen-flask method......................................................... 1392.5.11. Complexometric titrations................................................ 1402.5.12. Water : semi-micro determination ................................... 1402.5.13. Aluminium in adsorbed vaccines.....................................1412.5.14. Calcium in adsorbed vaccines ..........................................1412.5.15. Phenol in immunosera and vaccines ..............................1412.5.16. Protein in polysaccharide vaccines .................................1412.5.17. Nucleic acids in polysaccharide vaccines ...................... 1422.5.18. Phosphorus in polysaccharide vaccines........................ 1422.5.19. O-Acetyl in polysaccharide vaccines............................... 1422.5.1. Acid value............................................................................... 1372.5.20. Hexosamines in polysaccharide vaccines...................... 1422.5.21. Methylpentoses in polysaccharide vaccines ................. 1432.5.22. Uronic acids in polysaccharide vaccines ....................... 1432.5.23. Sialic acid in polysaccharide vaccines ........................... 1432.5.24. Carbon dioxide in gases.................................................... 1432.5.25. Carbon monoxide in gases............................................... 1442.5.26. Nitrogen monoxide and nitrogen dioxide in gases ..... 1452.5.27. Oxygen in gases .................................................................. 1452.5.28. Water in gases..................................................................... 1452.5.29. Sulfur dioxide ..................................................................... 1452.5.2. Ester value ............................................................................. 1372.5.30. Oxidising substances......................................................... 1462.5.31. Ribose in polysaccharide vaccines.................................. 1462.5.32. Water : micro determination ............................................ 1462.5.33. Total protein........................................................................ 147
General Notices (1) apply to all monographs and other texts 3267
Index EUROPEAN PHARMACOPOEIA 7.0
2.5.34. Acetic acid in synthetic peptides .................................... 1502.5.35. Nitrous oxide in gases ....................................................... 1502.5.36. Anisidine value ................................................................... 1502.5.3. Hydroxyl value ...................................................................... 1372.5.4. Iodine value ........................................................................... 1372.5.5. Peroxide value....................................................................... 1382.5.6. Saponification value ............................................................ 1392.5.7. Unsaponifiable matter ......................................................... 1392.5.8. Determination of primary aromatic amino-nitrogen .... 1392.5.9. Determination of nitrogen by sulfuric acid digestion .. 1392.5. Assays ......................................................................................... 1372.6.10. Histamine ............................................................................. 1622.6.11. Depressor substances........................................................ 1622.6.12. Microbiological examination of non-sterile products :microbial enumeration tests........................................................ 163
2.6.14. Bacterial endotoxins .......................................................... 1712.6.15. Prekallikrein activator....................................................... 1752.6.16. Tests for extraneous agents in viral vaccines for humanuse .................................................................................................... 176
2.6.17. Test for anticomplementary activity ofimmunoglobulin............................................................................. 177
2.6.18. Test for neurovirulence of live virus vaccines.............. 1792.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ................................................................................................. 179
2.6.25. Avian live virus vaccines : tests for extraneous agents inbatches of finished product......................................................... 188
2.6.26. Test for anti-D antibodies in human immunoglobulin forintravenous administration ......................................................... 191
2.6.27. Microbiological control of cellular products ................ 1912.6.2. Mycobacteria ......................................................................... 1562.6.30. Monocyte-activation test ................................................... 1922.6.31. Microbiological examination of herbal medicinalproducts for oral use..................................................................... 197
2.6.7. Mycoplasmas.......................................................................... 1562.6.8. Pyrogens................................................................................. 1612.6.9. Abnormal toxicity ................................................................. 1622.6. Biological tests ......................................................................... 1532.7.10. Assay of human coagulation factor VII ......................... 2192.7.11. Assay of human coagulation factor IX ........................... 2192.7.12. Assay of heparin in coagulation factors ........................ 2202.7.13. Assay of human anti-D immunoglobulin....................... 2202.7.14. Assay of hepatitis A vaccine ............................................. 2222.7.15. Assay of hepatitis B vaccine (rDNA)............................... 2232.7.16. Assay of pertussis vaccine (acellular)............................. 2232.7.17. Assay of human antithrombin III .................................... 2242.7.18. Assay of human coagulation factor II ............................ 2242.7.19. Assay of human coagulation factor X ............................ 2252.7.19. Assay of human coagulation factor X (2.7.19.)............. 2252.7.1. Immunochemical methods ................................................. 2012.7.20. In vivo assay of poliomyelitis vaccine (inactivated).... 2252.7.21. Assay of human von Willebrand factor.......................... 2262.7.22. Assay of human coagulation factor XI........................... 2272.7.23. Numeration of CD34/CD45+ cells in haemato-poietic products ............................................................................. 228
2.7.24. Flow cytometry ................................................................... 2292.7.25. Assay of human plasmin inhibitor .................................. 2302.7.27. Flocculation value (Lf) of diphtheria and tetanus toxinsand toxoids (Ramon assay) .......................................................... 231
2.7.28. Colony-forming cell assay for human haematopoietic pro-genitor cells..................................................................................... 232
2.7.29. Nucleated cell count and viability................................... 2332.7.2. Microbiological assay of antibiotics .................................. 2022.7.30. Assay of human protein C ................................................ 2342.7.31. Assay of human protein S................................................. 2352.7.32. Assay of human α-1-proteinase inhibitor ...................... 2362.7.4. Assay of human coagulation factor VIII .......................... 2072.7.5. Assay of heparin.................................................................... 2082.7.6. Assay of diphtheria vaccine (adsorbed) ........................... 2092.7.7. Assay of pertussis vaccine................................................... 2132.7.8. Assay of tetanus vaccine (adsorbed)................................. 2142.7.9. Test for Fc function of immunoglobulin ..........................2172.7. Biological assays ...................................................................... 2012.8.10. Solubility in alcohol of essential oils ............................. 2402.8.11. Assay of 1,8-cineole in essential oils .............................. 2402.8.12. Determination of essential oils in herbal drugs .......... 2412.8.13. Pesticide residues............................................................... 2422.8.14. Determination of tannins in herbal drugs .................... 2432.8.15. Bitterness value .................................................................. 2442.8.16. Dry residue of extracts...................................................... 2442.8.17. Loss on drying of extracts ................................................ 2442.8.18. Determination of aflatoxin B1 in herbal drugs ............ 2442.8.1. Ash insoluble in hydrochloric acid ................................... 2392.8.20. Herbal drugs : sampling and sample preparation........ 2462.8.21. Test for aristolochic acids in herbal drugs ................... 2472.8.22. Determination of ochratoxin A in herbal drugs.......... 2492.8.23. Microscopic examination of herbal drugs .................... 2502.8.2. Foreign matter ...................................................................... 2392.8.3. Stomata and stomatal index .............................................. 2392.8.4. Swelling index....................................................................... 2392.8.5. Water in essential oils.......................................................... 2392.8.6. Foreign esters in essential oils .......................................... 2392.8.7. Fatty oils and resinified essential oils in essential oils .. 2392.8.8. Odour and taste of essential oils....................................... 2402.8.9. Residue on evaporation of essential oils ......................... 2402.8. Methods in pharmacognosy .................................................. 2392.9.10. Ethanol content and alcoholimetric tables .................. 2682.9.11. Test for methanol and 2-propanol .................................. 2702.9.12. Sieve test .............................................................................. 2702.9.14. Specific surface area by air permeability ...................... 2712.9.16. Flowability............................................................................ 2722.9.17. Test for extractable volume of parenteralpreparations .................................................................................... 273
2.9.17. Test for extractable volume of parenteral preparations(5.8.).................................................................................................. 622
2.9.19. Particulate contamination : sub-visible particles ......... 2852.9.1. Disintegration of tablets and capsules............................. 2532.9.20. Particulate contamination: visible particles ................ 2872.9.22. Softening time determination of lipophilicsuppositories................................................................................... 288
2.9.23. Gas pycnometric density of solids .................................. 2882.9.25. Dissolution test for medicated chewing gums............. 2892.9.26. Specific surface area by gas adsorption........................ 2912.9.26. Specific surface area by gas adsorption (5.8.) ............. 6222.9.27. Uniformity of mass of delivered doses from multidosecontainers........................................................................................ 294
2.9.29. Intrinsic dissolution........................................................... 2942.9.2. Disintegration of suppositories and pessaries ............... 2552.9.31. Particle size analysis by laser light diffraction ............ 2952.9.32. Porosity and pore-size distribution of solids by mercuryporosimetry ..................................................................................... 299
2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD)............................... 301
2.9.34. Bulk density and tapped density of powders............... 3052.9.35. Powder fineness ................................................................. 3082.9.36. Powder flow......................................................................... 3082.9.36. Powder flow (5.8.) .............................................................. 6222.9.37. Optical microscopy..............................................................3112.9.37. Optical microscopy (5.8.) .................................................. 6222.9.38. Particle-size distribution estimation by analyticalsieving .............................................................................................. 313
3268 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.0 Index
2.9.38. Particle-size distribution estimation by analytical sieving(5.8.).................................................................................................. 623
2.9.3. Dissolution test for solid dosage forms ........................... 2562.9.40. Uniformity of dosage units............................................... 3152.9.41. Friability of granules and spheroids .............................. 3182.9.42. Dissolution test for lipophilic solid dosage forms....... 3192.9.43. Apparent dissolution ......................................................... 3202.9.45. Wettability of porous solids including powders .......... 3212.9.4. Dissolution test for transdermal patches ........................ 2632.9.5. Uniformity of mass of single-dose preparations............. 2652.9.6. Uniformity of content of single-dose preparations........ 2662.9.7. Friability of uncoated tablets ............................................. 2662.9.7. Friability of uncoated tablets (5.8.)................................... 6222.9.8. Resistance to crushing of tablets...................................... 2672.9.9. Measurement of consistency by penetrometry .............. 2672.9. Pharmaceutical technical procedures ................................. 2533.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ............ 349
3.1.11. Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration...... 350
3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components............. 329
3.1.1.2. Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents..................................................................................... 332
3.1.13. Plastic additives .................................................................. 3523.1.14. Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion ..355
3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use........................................... 357
3.1.1. Materials for containers for human blood and bloodcomponents..................................................................................... 329
3.1.3. Polyolefines............................................................................ 3343.1.4. Polyethylene without additives for containers forparenteral preparations and for ophthalmic preparations ...337
3.1.5. Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations ....................... 338
3.1.6. Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations.............................. 342
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations..................................... 345
3.1.8. Silicone oil used as a lubricant ......................................... 3473.1.9. Silicone elastomer for closures and tubing .................... 3473.1. Materials used for the manufacture of containers ........... 3293.2.1. Glass containers for pharmaceutical use ........................ 3633.2.2.1. Plastic containers for aqueous solutions forinfusion ............................................................................................ 368
3.2.2. Plastic containers and closures for pharmaceuticaluse..................................................................................................... 368
3.2.3. Sterile plastic containers for human blood andblood components ......................................................................... 369
3.2.4. Empty sterile containers of plasticised poly(vinyl chloride)for human blood and blood components ................................. 370
3.2.6. Sets for the transfusion of blood and bloodcomponents..................................................................................... 371
3.2.8. Sterile single-use plastic syringes ..................................... 3733.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders ..................................................................... 374
3.2. Containers ................................................................................. 3634.1.1. Reagents ................................................................................. 3794.1.2. Standard solutions for limit tests...................................... 4854.1.3. Buffer solutions .................................................................... 4894.1. Reagents, standard solutions, buffer solutions ................. 3794.2.1. Primary standards for volumetric solutions................... 4944.2.2. Volumetric solutions............................................................ 4944.2. Volumetric analysis.................................................................. 4944-Aminobenzoic acid .....................................................................13714. Reagents........................................................................................ 3795.10. Control of impurities in substances for pharmaceuticaluse..................................................................................................... 631
5.1.10. Guidelines for using the test for bacterial endotoxins .. 5205.11. Characters section in monographs .................................... 6375.1.1. Methods of preparation of sterile products .................... 5035.1.2. Biological indicators of sterilisation................................. 5045.12. Reference standards.............................................................. 6415.1.3. Efficacy of antimicrobial preservation ............................. 5055.14. Gene transfer medicinal products for human use .......... 6475.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use ........... 507
5.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use (5.8.) .. 623
5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ................................................................... 508
5.15. Functionality-related characteristics of excipients......... 6615.1.6. Alternative methods for control of microbiologicalquality............................................................................................... 508
5.17.1. Recommendations on dissolution testing ..................... 6655.17. Recommendations on methods for dosage formstesting............................................................................................... 665
5.1.7. Viral safety.............................................................................. 5185.1.8. Microbiological quality of herbal medicinal products fororal use ............................................................................................ 519
5.1.9. Guidelines for using the test for sterility ........................ 5195.1. General texts on microbiology .............................................. 5035.2.1. Terminology used in monographs on biologicalproducts ........................................................................................... 527
5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines ............................. 527
5.2.3. Cell substrates for the production of vaccines for humanuse..................................................................................................... 530
5.2.4. Cell cultures for the production of veterinaryvaccines............................................................................................ 533
5.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products........................ 535
5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ................................................................................... 536
5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .................................................................................... 538
5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ........................................................................................... 539
5.2.9. Evaluation of safety of each batch of veterinary vaccinesand immunosera ............................................................................ 547
5.2. General texts on biological products................................... 5275.3. Statistical analysis of results of biological assays andtests................................................................................................... 551
5.4. Residual solvents ..................................................................... 5835.5. Alcoholimetric tables .............................................................. 5935.6. Assay of interferons................................................................. 6075.7. Table of physical characteristics of radionuclides mentionedin the European Pharmacopoeia ............................................... 611
Analytical sieving, particle-size distribution estimation by(2.9.38.) (5.8.) ................................................................................. 623
Angelica root ...................................................................................1049Animal anti-T lymphocyte immunoglobulin for human use ..1404Animal immunosera for human use............................................. 678Animal spongiform encephalopathies, products with risk oftransmitting agents of................................................................... 686
Animal spongiform encephalopathy agents, minimising the riskof transmitting via human and veterinary medicinal products(5.2.8.) .............................................................................................. 539
Aniseed .............................................................................................1052Anise oil............................................................................................1050Anisidine value (2.5.36.) ................................................................. 150Antazoline hydrochloride............................................................. 1401Anthrax spore vaccine (live) for veterinary use......................... 847Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates) ............................................................................. 745
Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) ............................................................................................ 180
Antibiotics, microbiological assay of (2.7.2.) .............................. 202Antibodies (anti-D) in human immunoglobulin for intravenousadministration, test for (2.6.26.) ................................................. 191
Antibodies for human use, monoclonal ...................................... 682
3270 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.0 Index
Anticoagulant and preservative solutions for human blood......................................................................................................... 1401
Anticomplementary activity of immunoglobulin (2.6.17.)....... 177Anti-D antibodies in human immunoglobulin for intravenousadministration, test for (2.6.26.) ................................................. 191
Anti-D immunoglobulin for intravenous administration,human ............................................................................................ 2167
Anti-D immunoglobulin, human ................................................. 2166Anti-D immunoglobulin, human, assay of (2.7.13.)................... 220Antimicrobial preservation, efficacy of (5.1.3.) .......................... 505Antiserum, European viper venom .............................................. 953Antithrombin III concentrate, human ....................................... 2168Antithrombin III, human, assay of (2.7.17.) ................................ 224Anti-T lymphocyte immunoglobulin for human use, animal ..1404Apomorphine hydrochloride .......................................................1407Apparatus (2.1.) .................................................................................. 15Apparent dissolution (2.9.43.) ....................................................... 320Application of the F0 concept to steam sterilisation of aqueouspreparations (5.1.5.) ...................................................................... 508
Aprotinin ..........................................................................................1408Aprotinin concentrated solution................................................. 1411Arachis oil, hydrogenated ............................................................ 1413Arachis oil, refined......................................................................... 1413Arginine............................................................................................ 1414Arginine aspartate ......................................................................... 1415Arginine hydrochloride................................................................. 1415Argon ................................................................................................ 1416Aristolochic acids in herbal drugs, test for (2.8.21) ................. 247Arnica flower...................................................................................1053Arnica tincture................................................................................1055Arsenic (2.4.2.) .................................................................................. 113Arsenious trioxide for homoeopathic preparations................1286Articaine hydrochloride................................................................ 1417Artichoke leaf..................................................................................1056Artichoke leaf dry extract ............................................................1058Ascorbate, calcium.........................................................................1548Ascorbate, sodium ......................................................................... 2912Ascorbic acid ................................................................................... 1418Ascorbyl palmitate .........................................................................1420Ash insoluble in hydrochloric acid (2.8.1.)................................. 239Ash leaf.............................................................................................1059Ash, sulfated (2.4.14.)...................................................................... 118Ash, sulfated (2.4.14.) (5.8.) ........................................................... 622Asparagine monohydrate ............................................................. 1421Aspartame........................................................................................ 1421Aspartic acid....................................................................................1423Assay of 1,8-cineole in essential oils (2.8.11.) ............................ 240Assay of diphtheria vaccine (adsorbed) (2.7.6.) ......................... 209Assay of heparin (2.7.5.) ................................................................. 208Assay of heparin in coagulation factors (2.7.12.) ...................... 220Assay of hepatitis A vaccine (2.7.14.) ........................................... 222Assay of hepatitis B vaccine (rDNA) (2.7.15.) ............................ 223Assay of human anti-D immunoglobulin (2.7.13.)..................... 220Assay of human antithrombin III (2.7.17.) .................................. 224Assay of human coagulation factor II (2.7.18.).......................... 224Assay of human coagulation factor IX (2.7.11.)......................... 219Assay of human coagulation factor VII (2.7.10.) ....................... 219Assay of human coagulation factor VIII (2.7.4.)........................ 207Assay of human coagulation factor X (2.7.19.) .......................... 225Assay of human coagulation factor XI (2.7.22.) ........................ 227Assay of human plasmin inhibitor (2.7.25.)................................ 230Assay of human protein C (2.7.30.) .............................................. 234Assay of human protein S (2.7.31.)............................................... 235Assay of human von Willebrand factor (2.7.21.) ....................... 226Assay of interferons (5.6.) .............................................................. 607Assay of pertussis vaccine (2.7.7.)................................................. 213Assay of pertussis vaccine (acellular) (2.7.16.) .......................... 223Assay of poliomyelitis vaccine (inactivated), in vivo (2.7.20.) .. 225Assay of tetanus vaccine (adsorbed) (2.7.8.) .............................. 214Assays (2.5.) ....................................................................................... 137Astragalus mongholicus root ......................................................1060Atenolol ............................................................................................1424Atomic absorption spectrometry (2.2.23.) .................................... 36
Avian paramyxovirus 3 vaccine (inactivated)............................. 860Avian tuberculin purified protein derivative............................ 3161Avian viral tenosynovitis vaccine (live)........................................ 861Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) ............................................................................................ 185
Azaperone for veterinary use ......................................................1430Azathioprine.................................................................................... 1431Azelastine hydrochloride..............................................................1433Azithromycin...................................................................................1434
BB19 virus (B19V), validation of nucleic acid amplificationtechniques for the quantification of B19V DNA in plasmapools : guidelines............................................................................ 181
Bacampicillin hydrochloride........................................................1439Bacitracin.........................................................................................1440Bacitracin zinc ................................................................................1443Baclofen ...........................................................................................1445Bacterial endotoxins (2.6.14.)........................................................ 171Bacterial endotoxins, guidelines for using the test for(5.1.10.) ............................................................................................ 520
Biological indicators of sterilisation (5.1.2.) .............................. 504Biological products, general texts on (5.2.)................................ 527Biological products, terminology used in monographs on(5.2.1.)............................................................................................... 527
Biological tests (2.6.) ....................................................................... 153Biotin ................................................................................................1492Biperiden hydrochloride...............................................................1493Biphasic insulin injection.............................................................2243Biphasic isophane insulin injection ...........................................2244Birch leaf..........................................................................................1071Bisacodyl..........................................................................................1495Bismuth subcarbonate..................................................................1496Bismuth subgallate........................................................................1497Bismuth subnitrate, heavy ...........................................................1498Bismuth subsalicylate ...................................................................1498Bisoprolol fumarate.......................................................................1499Bistort rhizome ..............................................................................1072Bitter fennel ....................................................................................1124Bitter-fennel fruit oil......................................................................1073Bitter-fennel herb oil .....................................................................1075Bitterness value (2.8.15.)................................................................ 244Bitter-orange epicarp and mesocarp..........................................1077Bitter-orange-epicarp and mesocarp tincture ..........................1078Bitter-orange flower ......................................................................1078Bitter-orange-flower oil ................................................................. 1194Black horehound ...........................................................................1079Bleomycin sulfate...........................................................................1502Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ............................... 370
Blood and blood components, materials for containers for(3.1.1.)............................................................................................... 329
Blood and blood components, sets for the transfusion of(3.2.6.) .............................................................................................. 371
Blood and blood components, sterile plastic containers for(3.2.3.) .............................................................................................. 369
Blood, anticoagulant and preservative solutions for ............. 1401Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.) ............................... 371
Ceftriaxone sodium........................................................................1626Cefuroxime axetil ...........................................................................1627Cefuroxime sodium........................................................................1629Celiprolol hydrochloride...............................................................1630Cell count and viability, nucleated (2.7.29.) ............................... 233Cell cultures for the production of veterinary vaccines(5.2.4.) .............................................................................................. 533
Cell substrates for the production of vaccines for human use(5.2.3.) .............................................................................................. 530
Ciprofibrate .....................................................................................1697Ciprofloxacin...................................................................................1698Ciprofloxacin hydrochloride........................................................1700Circular dichroism (2.2.41.) ............................................................. 65Cisplatin ........................................................................................... 1701Citalopram hydrobromide ............................................................1703Citalopram hydrochloride ............................................................1704Citric acid, anhydrous ...................................................................1705Citric acid monohydrate ...............................................................1706Citronella oil.................................................................................... 1103Cladribine ........................................................................................1707Clarithromycin................................................................................1708Clarity and degree of opalescence of liquids (2.2.1.)...................21Clary sage oil................................................................................... 1104Classical swine-fever vaccine (live, prepared in cell cultures) .. 940Clazuril for veterinary use ........................................................... 1710Clebopride malate .......................................................................... 1712Clemastine fumarate ..................................................................... 1713Clenbuterol hydrochloride........................................................... 1715Clindamycin hydrochloride.......................................................... 1716Clindamycin phosphate ................................................................ 1717Clioquinol ........................................................................................ 1718Clobazam ......................................................................................... 1719Clobetasol propionate...................................................................1720Clobetasone butyrate ....................................................................1722Clodronate disodium tetrahydrate .............................................1723Clofazimine......................................................................................1724Clofibrate .........................................................................................1725Clomifene citrate ............................................................................1726Clomipramine hydrochloride.......................................................1727Clonazepam.....................................................................................1729Clonidine hydrochloride...............................................................1730Clopamide........................................................................................ 1731Clorazepate, dipotassium.............................................................1869Closantel sodium dihydrate for veterinary use .......................1732Clostridium botulinum vaccine for veterinary use ................... 878Clostridium chauvoei vaccine for veterinary use...................... 879Clostridium novyi alpha antitoxin for veterinary use .............. 957Clostridium novyi (type B) vaccine for veterinary use............. 879Clostridium perfringens beta antitoxin for veterinary use .... 958Clostridium perfringens epsilon antitoxin for veterinary use........................................................................................................... 959
Clostridium perfringens vaccine for veterinary use ................. 881Clostridium septicum vaccine for veterinary use...................... 883Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.).............. 342
Closures and containers for pharmaceutical use, plastic(3.2.2.) .............................................................................................. 368
Closures and tubing, silicone elastomer for (3.1.9.) ................. 347Closures for containers for aqueous parenteral preparations, forpowders and for freeze-dried powders, rubber (3.2.9.) ......... 374
Clotrimazole....................................................................................1734Clove ................................................................................................. 1105Clove oil ........................................................................................... 1106Cloxacillin sodium..........................................................................1735Clozapine .........................................................................................1737Coagulation factor II, assay of (2.7.18.)....................................... 224Coagulation factor IX, human..................................................... 2172Coagulation factor IX, human, assay of (2.7.11.)....................... 219Coagulation factors, activated (2.6.22.)....................................... 185Coagulation factors, assay of heparin (2.7.12.) ......................... 220Coagulation factor VII, human ................................................... 2169Coagulation factor VII, human, assay of (2.7.10.)..................... 219Coagulation factor VIII, human.................................................. 2170Coagulation factor VIII, human, assay of (2.7.4.)...................... 207Coagulation factor VIII (rDNA), human ................................... 2171Coagulation factor X, assay of (2.7.19.) ....................................... 225Coagulation factor XI, human..................................................... 2173Coagulation factor XI, human, assay of (2.7.22.) ...................... 227Coated granules ............................................................................... 714Coated tablets ................................................................................... 737Cocaine hydrochloride..................................................................1738Coccidiosis vaccine (live) for chickens ........................................ 884
3274 See the information section on general monographs (cover pages)
Colophony ....................................................................................... 1107Coloration of liquids (2.2.2.)............................................................ 22Common stinging nettle for homoeopathic preparations.....1288Comparative table of porosity of sintered-glass filters (2.1.2.).. 15Complexometric titrations (2.5.11.).............................................. 140Composition of fatty acids by gas chromatography (2.4.22.).. 119Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) ............................................................................................ 130
Compressed lozenges...................................................................... 723Concentrated solutions for haemodialysis ............................... 2136Concentrates for injections or infusions..................................... 725Concentrates for intrauterine solutions...................................... 715Conductivity (2.2.38.) ........................................................................ 59Coneflower herb, purple .............................................................. 1218Coneflower root, narrow-leaved.................................................. 1193Coneflower root, pale....................................................................1208Coneflower root, purple ............................................................... 1219Conjugated estrogens ...................................................................1958Consistency by penetrometry, measurement of (2.9.9.) .......... 267Containers (3.2.)............................................................................... 363Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.).............. 342
Containers and closures for pharmaceutical use, plastic(3.2.2.) .............................................................................................. 368
Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ......... 345
Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ........................................................................................... 368
Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ............................................................................................ 355
Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)............................................................................................. 350
Containers for human blood and blood components, materialsbased on plasticised poly(vinyl chloride) for (3.1.1.1.) .......... 329
Containers for human blood and blood components, materialsfor (3.1.1.) ........................................................................................ 329
Containers for human blood and blood components, plastic,sterile (3.2.3.) .................................................................................. 369
Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for (3.1.10.) ... 349
Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ........... 338
Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for (3.1.4.) ..... 337
Containers for pharmaceutical use, glass (3.2.1.)..................... 363Containers for preparations not for parenteral use, polyethyleneterephthalate for (3.1.15) ............................................................. 357
Containers of plasticised poly(vinyl chloride) for human bloodand blood components, empty sterile (3.2.4.) ......................... 370
Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.) ................. 371
Contamination, microbial : test for specified micro-organisms(2.6.13.) ............................................................................................ 167
Contamination, microbial : test for specified micro-organisms(2.6.13.) (5.8.) ................................................................................. 622
Content uniformity of single-dose preparations (2.9.6.).......... 266Control of impurities in substances for pharmaceutical use(5.10.)................................................................................................ 631
Control of microbiological quality, alternative methods for(5.1.6.)............................................................................................... 508
DDacarbazine.....................................................................................1787Dalteparin sodium .........................................................................1788Danaparoid sodium .......................................................................1789Dandelion herb with root............................................................. 1110Dandelion root................................................................................ 1111Dapsone ...........................................................................................1792
General Notices (1) apply to all monographs and other texts 3275
Index EUROPEAN PHARMACOPOEIA 7.0
Daunorubicin hydrochloride .......................................................1792D-Camphor .......................................................................................1569Decyl oleate .....................................................................................1794Deferoxamine mesilate..................................................................1794Degree of coloration of liquids (2.2.2.).......................................... 22Dembrexine hydrochloride monohydrate for veteri-nary use .........................................................................................1795
Demeclocycline hydrochloride....................................................1796Density of powders, bulk density and tapped (2.9.34.) ........... 305Density of solids (2.2.42.) ................................................................. 66Density of solids, gas pycnometric (2.9.23.)............................... 288Density, relative (2.2.5.) .................................................................... 25Dental type silica............................................................................2903Depressor substances (2.6.11.)...................................................... 162Deptropine citrate..........................................................................1797Dequalinium chloride....................................................................1798Desflurane .......................................................................................1800Desipramine hydrochloride ......................................................... 1801Deslanoside .....................................................................................1802Desmopressin..................................................................................1803Desogestrel ......................................................................................1804Desoxycortone acetate..................................................................1805Detector tubes, gas (2.1.6.) ...............................................................17Determination of aflatoxin B1 in herbal drugs (2.8.18.).......... 244Determination of essential oils in herbal drugs (2.8.12.)........ 241Determination of nitrogen by sulfuric acid digestion (2.5.9.) .. 139Determination of primary aromatic amino-nitrogen (2.5.8.) .. 139Determination of tannins in herbal drugs (2.8.14.).................. 243Determination of water by distillation (2.2.13.) ...........................31Detomidine hydrochloride for veterinary use .........................1806Devil’s claw dry extract................................................................. 1112Devil’s claw root ............................................................................. 1113Dexamethasone ..............................................................................1807Dexamethasone acetate................................................................1809Dexamethasone isonicotinate ..................................................... 1811Dexamethasone sodium phosphate ........................................... 1812Dexchlorpheniramine maleate .................................................... 1814Dexpanthenol.................................................................................. 1815Dextran 1 for injection.................................................................. 1816Dextran 40 for injection ............................................................... 1817Dextran 60 for injection ............................................................... 1818Dextran 70 for injection ............................................................... 1819Dextranomer ................................................................................... 1819Dextrans, molecular mass distribution in (2.2.39.) .................... 60Dextrin..............................................................................................1820Dextromethorphan hydrobromide ............................................. 1821Dextromoramide tartrate .............................................................1822Dextropropoxyphene hydrochloride..........................................1823Diazepam .........................................................................................1824Diazoxide .........................................................................................1825Dibrompropamidine diisetionate ................................................1826Dibutyl phthalate ...........................................................................1827Dichloromethane............................................................................2474Diclazuril for veterinary use........................................................1828Diclofenac potassium ....................................................................1829Diclofenac sodium .........................................................................1830Dicloxacillin sodium ...................................................................... 1831Dicycloverine hydrochloride........................................................1833Didanosine.......................................................................................1833Dienestrol ........................................................................................1835Diethylcarbamazine citrate ..........................................................1836Diethylene glycol and ethylene glycol in ethoxylated substances(2.4.30.) ............................................................................................ 132
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B(rDNA), poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)...................................................... 765
Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768
Diphtheria, tetanus, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771
Diphtheria, tetanus, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772
3276 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.0 Index
Dispersible tablets ........................................................................... 737Dissolution, apparent (2.9.43.)...................................................... 320Dissolution, intrinsic (2.9.29.) ....................................................... 294Dissolution test for lipophilic solid dosage forms (2.9.42.) .... 319Dissolution test for medicated chewing gums (2.9.25.) .......... 289Dissolution test for solid dosage forms (2.9.3.) ......................... 256Dissolution test for transdermal patches (2.9.4.)...................... 263Dissolution testing, recommendations on (5.17.1.) .................. 665Distemper vaccine (live), canine ................................................... 872Distemper vaccine (live) for mustelids ........................................ 887Distillation range (2.2.11.)................................................................ 30Distribution estimation by analytical sieving, particle-size(2.9.38.) ............................................................................................ 313
Distribution estimation by analytical sieving, particle-size(2.9.38.) (5.8.) ................................................................................. 623
Efficacy of veterinary vaccines and immunosera, evaluation of(5.2.7.)............................................................................................... 538
Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) ...................................................................... 547
Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) .............................................................................................. 536
Evening primrose oil, refined...................................................... 1991Extractable volume of parenteral preparations, test for(2.9.17.)............................................................................................. 273
Extractable volume of parenteral preparations, test for (2.9.17.)(5.8.).................................................................................................. 622
Extracts .............................................................................................. 674Extracts, dry ...................................................................................... 676Extracts, dry residue of (2.8.16.)................................................... 244Extracts, liquid.................................................................................. 675Extracts, loss on drying of (2.8.17.).............................................. 244Extracts, soft ..................................................................................... 676Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ............................................................................................ 176
Extraneous agents : tests in batches of finished product of avianlive virus vaccines (2.6.25.).......................................................... 188
Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) ............................................................................................ 185
FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .................................................................... 508
Factor II, human coagulation, assay of (2.7.18.) ....................... 224Factor IX, human coagulation .................................................... 2172Factor IX, human coagulation, assay of (2.7.11.) ...................... 219Factor VII, human coagulation................................................... 2169Factor VII, human coagulation, assay of (2.7.10.) .................... 219Factor VIII, human coagulation ................................................. 2170Factor VIII, human coagulation, assay of (2.7.4.) ..................... 207Factor VIII (rDNA), human coagulation ................................... 2171Factor X, human coagulation, assay of (2.7.19.) ....................... 225Factor XI, human coagulation .................................................... 2173Factor XI, human coagulation, assay of (2.7.22.)...................... 227Falling ball viscometer method (2.2.49.) ...................................... 83Famotidine.......................................................................................1995Fat, hard........................................................................................... 2146Fatty acids, composition by gas chromatography (2.4.22.) .... 119Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) ............................................................................................ 130
Fatty oils, alkaline impurities in (2.4.19.) ................................... 119Fatty oils and herbal drugs, heavy metals in (2.4.27.) ............. 129Fatty oils and resinified essential oils in essential oils(2.8.7.)............................................................................................... 239
Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) ............................................................................................ 119
Fatty oils, identification by thin-layer chromatography(2.3.2.) .............................................................................................. 110
Fatty oils, sterols in (2.4.23.) ......................................................... 121Fatty oils, vegetable......................................................................... 703Fc function of immunoglobulin, test for (2.7.9.) ........................217Febantel for veterinary use..........................................................1996Felbinac ............................................................................................1997Feline calicivirosis vaccine (inactivated) ..................................... 895Feline calicivirosis vaccine (live)................................................... 896Feline chlamydiosis vaccine (inactivated)................................... 897Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .................................................................................... 898
GGalactose..........................................................................................2083Galantamine hydrobromide .........................................................2083Gallium (67Ga) citrate injection ..................................................... 975Ganciclovir.......................................................................................2086Gargles................................................................................................ 722Garlic for homoeopathic preparations ......................................1290Garlic powder.................................................................................. 1133Gas adsorption, specific surface area by (2.9.26.)..................... 291Gas adsorption, specific surface area by (2.9.26.) (5.8.).......... 622Gas chromatography (2.2.28.) ......................................................... 43Gas detector tubes (2.1.6.) ................................................................17Gases, carbon dioxide in (2.5.24.)................................................. 143Gases, carbon monoxide in (2.5.25.) ............................................ 144Gases, nitrogen monoxide and nitrogen dioxide in (2.5.26.).. 145Gases, nitrous oxide in (2.5.35.).................................................... 150Gases, oxygen in (2.5.27.) ............................................................... 145Gases, water in (2.5.28.).................................................................. 145Gas-gangrene antitoxin, mixed ...................................................... 950Gas-gangrene antitoxin (novyi) ..................................................... 950Gas-gangrene antitoxin (perfringens) .......................................... 951Gas-gangrene antitoxin (septicum)............................................... 952Gas pycnometric density of solids (2.9.23.) ................................ 288Gastro-resistant capsules ................................................................ 708Gastro-resistant granules................................................................ 714Gastro-resistant tablets ................................................................... 738Gelatin ..............................................................................................2087Gels...................................................................................................... 735Gels for injections ............................................................................ 725Gemcitabine hydrochloride..........................................................2088Gemfibrozil ......................................................................................2090General notices (1.)...............................................................................3General texts on biological products (5.2.) ................................ 527General texts on microbiology (5.1.)............................................ 503Gene transfer medicinal products for human use (5.14.)........ 647Gentamicin sulfate .........................................................................2091Gentian root .................................................................................... 1133Gentian tincture ............................................................................. 1134Gestodene ........................................................................................2092Ginger ............................................................................................... 1135Gingival solutions ............................................................................ 722Ginkgo dry extract, refined and quantified.............................. 1136Ginkgo leaf ...................................................................................... 1138Ginseng............................................................................................. 1140Glass containers for pharmaceutical use (3.2.1.) ...................... 363Glibenclamide .................................................................................2094Gliclazide..........................................................................................2096Glimepiride ......................................................................................2097Glipizide ...........................................................................................2098Glossary (dosage forms) ................................................................. 707Glucagon, human........................................................................... 2100Glucoheptonate, calcium..............................................................1554Glucose, anhydrous ....................................................................... 2102Glucose, liquid ................................................................................ 2103Glucose, liquid, spray-dried.......................................................... 2103Glucose monohydrate ................................................................... 2104Glutamic acid .................................................................................. 2105Glutathione...................................................................................... 2106Glycan analysis of glycoproteins (2.2.59.)..................................... 97Glycerol ............................................................................................ 2108Glycerol (85 per cent).................................................................... 2109Glycerol dibehenate ....................................................................... 2110
General Notices (1) apply to all monographs and other texts 3279
Index EUROPEAN PHARMACOPOEIA 7.0
Glycerol distearate ......................................................................... 2111Glycerol monocaprylate................................................................ 2112Glycerol monocaprylocaprate...................................................... 2113Glycerol monolinoleate ................................................................. 2114Glycerol mono-oleate..................................................................... 2115Glycerol monostearate 40-55....................................................... 2116Glycerol triacetate.......................................................................... 3127Glyceryl trinitrate solution........................................................... 2117Glycine .............................................................................................. 2118Glycoproteins, glycan analysis of (2.2.59.).................................... 97Glycyrrhizate ammonium.............................................................1384Goldenrod ........................................................................................ 1141Goldenrod, European.................................................................... 1142Goldenseal rhizome....................................................................... 1143Gonadorelin acetate ...................................................................... 2119Gonadotrophin, chorionic ............................................................2120Gonadotrophin, equine serum, for veterinary use.................. 2121Goserelin .......................................................................................... 2121Grafted copolymer, macrogol poly(vinyl alcohol) ...................2401Gramicidin .......................................................................................2123Granisetron hydrochloride...........................................................2124Granules ............................................................................................. 713Granules and powders for oral solutions and suspensions .... 718Granules and powders for syrups................................................. 719Granules and spheroids, friability of (2.9.41.)............................ 318Granules, coated............................................................................... 714Granules, effervescent..................................................................... 714Granules, gastro-resistant............................................................... 714Granules, modified-release............................................................. 714Greater celandine ........................................................................... 1145Griseofulvin .....................................................................................2126Guaiacol ...........................................................................................2127Guaifenesin......................................................................................2128Guanethidine monosulfate...........................................................2129Guar .................................................................................................. 1146Guar galactomannan ..................................................................... 2130Guidelines for using the test for bacterial endotoxins(5.1.10.) ............................................................................................ 520
Guidelines for using the test for sterility (5.1.9.) ...................... 519
HHaematopoietic products, numeration of CD34/CD45+ cells in(2.7.23.) ............................................................................................ 228
Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) ........................................................................... 232
Haematopoietic stem cells, human ............................................ 2175Haemodiafiltration and haemofiltration, solutions for.......... 2138Haemodialysis, concentrated solutions for .............................. 2136Haemodialysis solutions, concentrated, water for diluting ..2135Haemodialysis, solutions for........................................................ 2136Haemofiltration and haemodiafiltration, solutions for.......... 2138Haemophilus type b (conjugate), diphtheria, tetanus andpertussis (acellular, component) vaccine (adsorbed)............. 758
Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component) and poliomyelitis (inactivated) vaccine(adsorbed)........................................................................................ 768
Haemophilus type b (conjugate), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and poliomyelitis(inactivated) vaccine (adsorbed) ................................................. 765
Haemophilus type b (conjugate), diphtheria, tetanus, pertussisand poliomyelitis (inactivated) vaccine (adsorbed) ................ 772
Hawthorn berries ........................................................................... 1147Hawthorn leaf and flower ............................................................ 1148Hawthorn leaf and flower dry extract ....................................... 1149Hawthorn leaf and flower liquid extract, quantified.............. 1150Heavy bismuth subnitrate ............................................................1498Heavy kaolin.................................................................................... 2314Heavy magnesium carbonate ......................................................2409Heavy magnesium oxide............................................................... 2415Heavy metals (2.4.8.) ........................................................................114Heavy metals in herbal drugs and fatty oils (2.4.27.)............... 129Hedera helix for homoeopathic preparations.......................... 1291Helium .............................................................................................. 2146Heparin, assay of (2.7.5.) ................................................................ 208Heparin calcium ............................................................................. 2147Heparin in coagulation factors, assay of (2.7.12.)..................... 220Heparins, low-molecular-mass ..................................................... 2151Heparin sodium.............................................................................. 2149Hepatitis A immunoglobulin, human ........................................ 2176Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed)........................................................................................ 779
Hepatitis A vaccine, assay of (2.7.14.) .......................................... 222Hepatitis A vaccine (inactivated, adsorbed) ............................... 780Hepatitis A vaccine (inactivated, virosome) ............................... 781Hepatitis B immunoglobulin for intravenous administration,human ............................................................................................ 2176
Hepatitis B immunoglobulin, human ........................................ 2176Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed)........................................................................................ 753
Hepatitis B (rDNA), diphtheria, tetanus and pertussis (acellular,component) vaccine (adsorbed).................................................. 760
Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765
Hepatitis B vaccine (rDNA)............................................................ 784Hepatitis B vaccine (rDNA), assay of (2.7.15.) ........................... 223Hepatitis C virus (HCV), validation of nucleic acid amplificationtechniques for the detection of HCV RNA in plasma pools :guidelines ........................................................................................ 181
Heptaminol hydrochloride ........................................................... 2153Herbal drug preparations............................................................... 676Herbal drugs ..................................................................................... 676Herbal drugs and fatty oils, heavy metals in (2.4.27.).............. 129Herbal drugs, determination of aflatoxin B1 in (2.8.18.)......... 244Herbal drugs, determination of essential oils in herbal drugs(2.8.12.) ............................................................................................ 241
Herbal drugs, determination of tannins (2.8.14.) ..................... 243Herbal drugs for homoeopathic preparations .........................1275Herbal drugs, microscopic examination of (2.8.23) ................. 250Herbal drugs : sampling and sample preparation (2.8.20.) ..... 246Herbal drugs, test for aristolochic acids in (2.8.21) ................. 247Herbal medicinal products for oral use, microbial examination(2.6.31.) ............................................................................................ 197
Herbal medicinal products for oral use, microbiological quality(5.1.8.)............................................................................................... 519
Homoeopathic preparations, copper for...................................1289Homoeopathic preparations, garlic for .....................................1290Homoeopathic preparations, hedera helix for......................... 1291Homoeopathic preparations, herbal drugs for ........................1275Homoeopathic preparations, honey bee for.............................1292Homoeopathic preparations, hyoscyamus for .........................1292Homoeopathic preparations, hypericum for ............................1293Homoeopathic preparations, iron for ........................................1294Homoeopathic preparations, mother tinctures for.................1286Homoeopathic preparations, oriental cashew for...................1295Homoeopathic preparations, saffron for...................................1296Homoeopathic stocks (methods of preparation of) andpotentisation.................................................................................1277
Honey ............................................................................................... 2163Honey bee for homoeopathic preparations..............................1292Hop strobile..................................................................................... 1151Human α-1-proteinase inhibitor ................................................. 2184Human albumin injection, iodinated (125I).................................. 976Human albumin solution ............................................................. 2165Human anti-D immunoglobulin .................................................. 2166Human anti-D immunoglobulin, assay of (2.7.13.) ................... 220Human anti-D immunoglobulin for intravenousadministration .............................................................................. 2167
Human antithrombin III, assay of (2.7.17.) ................................. 224Human antithrombin III concentrate ........................................ 2168Human coagulation factor II, assay of (2.7.18.)......................... 224Human coagulation factor IX...................................................... 2172Human coagulation factor IX, assay of (2.7.11.)........................ 219Human coagulation factor VII .................................................... 2169Human coagulation factor VII, assay of (2.7.10.) ...................... 219Human coagulation factor VIII................................................... 2170Human coagulation factor VIII, assay of (2.7.4.)....................... 207Human coagulation factor VIII (rDNA)..................................... 2171Human coagulation factor X, assay of (2.7.19.) ......................... 225Human coagulation factor XI...................................................... 2173Human coagulation factor XI, assay of (2.7.22.) ....................... 227Human fibrinogen.......................................................................... 2174Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) ........................................................................... 232
Human haematopoietic stem cells ............................................. 2175Human hepatitis A immunoglobulin ......................................... 2176Human hepatitis B immunoglobulin ......................................... 2176Human hepatitis B immunoglobulin for intravenousadministration .............................................................................. 2176
Human insulin ................................................................................2241Human measles immunoglobulin............................................... 2177Human normal immunoglobulin................................................ 2177Human normal immunoglobulin for intravenousadministration .............................................................................. 2179
Human papillomavirus vaccine (rDNA) ...................................... 785Human plasma for fractionation................................................. 2181Human plasma (pooled and treated for virus inactivation) .. 2182Human plasmin inhibitor, assay of (2.7.25.)............................... 230Human protein C, assay of (2.7.30.) ............................................. 234Human protein S, assay of (2.7.31.) ............................................. 235Human prothrombin complex..................................................... 2185Human rabies immunoglobulin .................................................. 2186Human rubella immunoglobulin ................................................ 2187Human tetanus immunoglobulin ............................................... 2187Human varicella immunoglobulin.............................................. 2188Human varicella immunoglobulin for intravenousadministration .............................................................................. 2189
Human von Willebrand factor..................................................... 2189Human von Willebrand factor, assay of (2.7.21.) ...................... 226Hyaluronate, sodium.....................................................................2927Hyaluronidase ................................................................................ 2190Hydralazine hydrochloride .......................................................... 2191Hydrochloric acid, concentrated ................................................ 2192
IIbuprofen .........................................................................................2225Iceland moss.................................................................................... 1152ICH (5.8.)............................................................................................ 621Ichthammol .....................................................................................2227Identification (2.3.) .......................................................................... 107Identification and control of residual solvents (2.4.24.).......... 123Identification of fatty oils by thin-layer chromatography(2.3.2.) .............................................................................................. 110
Identification of phenothiazines by thin-layer chromatography(2.3.3.) .............................................................................................. 110
Identification reactions of ions and functional groups(2.3.1.)............................................................................................... 107
Idoxuridine ......................................................................................2227Ifosfamide ........................................................................................2228Imipenem .........................................................................................2230Imipramine hydrochloride ...........................................................2231Immunochemical methods (2.7.1.) ............................................... 201Immunoglobulin for human use, anti-T lymphocyte,animal.............................................................................................1404
Immunoglobulin for intravenous administration, humananti-D .............................................................................................. 2167
Immunoglobulin for intravenous administration, humanhepatitis B ..................................................................................... 2176
Immunoglobulin for intravenous administration, humannormal ............................................................................................ 2179
Immunoglobulin for intravenous administration, humanvaricella.......................................................................................... 2189
Immunoglobulin, human anti-D ................................................. 2166
General Notices (1) apply to all monographs and other texts 3281
Index EUROPEAN PHARMACOPOEIA 7.0
Immunoglobulin, human anti-D, assay of (2.7.13.) ................... 220Immunoglobulin, human hepatitis A......................................... 2176Immunoglobulin, human hepatitis B ........................................ 2176Immunoglobulin, human measles .............................................. 2177Immunoglobulin, human normal ............................................... 2177Immunoglobulin, human rabies ................................................. 2186Immunoglobulin, human rubella ............................................... 2187Immunoglobulin, human tetanus............................................... 2187Immunoglobulin, human varicella ............................................. 2188Immunoglobulin, test for anticomplementary activity of(2.6.17.)............................................................................................. 177
Immunoglobulin, test for Fc function of (2.7.9.)........................217Immunological veterinary medicinal products, substances ofanimal origin for the production of (5.2.5.) ............................. 535
Immunosera and vaccines, phenol in (2.5.15.) ...........................141Immunosera and vaccines, veterinary, evaluation of efficacy of(5.2.7.)............................................................................................... 538
Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) .............................................................................................. 536
Immunosera and vaccines, veterinary, evaluation of the safetyof each batch (5.2.9.)..................................................................... 547
Immunosera for human use, animal............................................ 678Immunosera for veterinary use..................................................... 680Implants ............................................................................................. 725Impurities in substances for pharmaceutical use, control of(5.10.)................................................................................................ 631
Indapamide......................................................................................2232Indian frankincense....................................................................... 1152Indicators, relationship between approximate pH and colour(2.2.4.) ................................................................................................ 25
Mass uniformity of single-dose preparations (2.9.5.) ............... 265Mastic................................................................................................ 1177Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)............................................................................................. 350
Materials based on non-plasticised poly(vinyl chloride) forcontainers for non-injectable, aqueous solutions (3.1.10.)... 349
Materials based on plasticised poly(vinyl chloride) for containersfor aqueous solutions for intravenous infusion (3.1.14.) ...... 355
Materials based on plasticised poly(vinyl chloride) for containersfor human blood and blood components (3.1.1.1.) ................ 329
Materials based on plasticised poly(vinyl chloride) for tubingused in sets for the transfusion of blood and blood components(3.1.1.2.) ........................................................................................... 332
Materials for containers for human blood and blood components(3.1.1.)............................................................................................... 329
Materials used for the manufacture of containers (3.1.) ......... 329Matricaria flower ............................................................................ 1178Matricaria liquid extract ............................................................... 1179
Matricaria oil ................................................................................... 1180Meadowsweet .................................................................................. 1182Measles immunoglobulin, human .............................................. 2177Measles, mumps and rubella vaccine (live) ................................ 798Measles, mumps, rubella and varicella vaccine (live)............... 799Measles vaccine (live) ...................................................................... 800Measurement of consistency by penetrometry (2.9.9.) ............ 267Mebendazole ...................................................................................2434Meclozine dihydrochloride ..........................................................2435Medicated chewing gums............................................................... 709Medicated chewing gums, dissolution test for (2.9.25.) .......... 289Medicated feeding stuffs for veterinary use, premixes for ...... 727Medicated foams............................................................................... 712Medicated plasters ........................................................................... 735Medicated tampons.......................................................................... 738Medicated vaginal tampons ........................................................... 740Medicinal air.................................................................................... 1331Medicinal air, synthetic.................................................................1333Medium-chain triglycerides.......................................................... 3138Medronic acid for radiopharmaceutical preparations.............. 984Medroxyprogesterone acetate .....................................................2437Mefenamic acid ...............................................................................2438Mefloquine hydrochloride............................................................2440Megestrol acetate ...........................................................................2441Meglumine.......................................................................................2442Melilot............................................................................................... 1183Melissa leaf ...................................................................................... 1184Melissa leaf dry extract ................................................................. 1185Meloxicam........................................................................................2443Melting point - capillary method (2.2.14.)......................................31Melting point - instantaneous method (2.2.16.) .......................... 32Melting point - open capillary method (2.2.15.) .......................... 32Menadione .......................................................................................2444Meningococcal group C conjugate vaccine................................ 802Meningococcal polysaccharide vaccine....................................... 803Menthol, racemic............................................................................2445Mepivacaine hydrochloride..........................................................2446Meprobamate ..................................................................................2447Mepyramine maleate .....................................................................2448Mercaptopurine ..............................................................................2449Mercuric chloride...........................................................................2449Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) ........................................................................... 299
Microbiological assay of antibiotics (2.7.2.)................................ 202Microbiological control of cellular products (2.6.27.).............. 191Microbiological examination of herbal medicinal products fororal use (2.6.31.)............................................................................. 197
Microbiological examination of non-sterile products : microbialenumeration tests (2.6.12.).......................................................... 163
Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ........................................... 167
Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) (5.8.)................................. 622
Microbiological quality, alternative methods for control of(5.1.6.)............................................................................................... 508
Microbiological quality of herbal medicinal products for oral use(5.1.8.)............................................................................................... 519
Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.)............................................................................................... 507
Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use (5.1.4.)(5.8.).................................................................................................. 623
Microbiology, general texts on (5.1.) ........................................... 503Microcrystalline cellulose.............................................................1634Microcrystalline cellulose and carmellose sodium.................2507Micro determination of water (2.5.32.)........................................ 146Microscopic examination of herbal drugs (2.8.23) ................... 250Microscopy, optical (2.9.37.) ...........................................................311Microscopy, optical (2.9.37.) (5.8.) ............................................... 622Midazolam .......................................................................................2508Milk thistle dry extract, refined and standardised.................. 1186Milk-thistle fruit.............................................................................. 1187Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ............................................................................. 539
Parenteral preparations.................................................................. 723Parenteral preparations, test for extractable volume of(2.9.17.)............................................................................................. 273
Parenteral preparations, test for extractable volume of (2.9.17.)(5.8.).................................................................................................. 622
Particles, fine, aerodynamic assessment of in preparations forinhalation (2.9.18.) ........................................................................ 274
Particle size analysis by laser light diffraction (2.9.31.) .......... 295Particle-size distribution estimation by analytical sieving(2.9.38.) ............................................................................................ 313
Particle-size distribution estimation by analytical sieving(2.9.38.) (5.8.) ................................................................................. 623
Pertussis (acellular, component), diphtheria, tetanus, hepatitis B(rDNA), poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed)...................................................... 765
Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768
Pertussis, diphtheria, tetanus and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771
Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772
Plasma (pooled and treated for virus inactivation), human.. 2182Plasmid vectors for human use, bacterial cells used for themanufacture of ............................................................................... 649
Plasmin inhibitor, assay of human (2.7.25.) ............................... 230Plasters, medicated.......................................................................... 734Plastic additives (3.1.13.)................................................................ 352Plastic containers and closures for pharmaceutical use(3.2.2.) .............................................................................................. 368
Plastic containers for aqueous solutions for infusion(3.2.2.1.) ........................................................................................... 368
Plastic containers for human blood and blood components,sterile (3.2.3.) .................................................................................. 369
Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)......................................................................... 771
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) ................ 772
Poliomyelitis vaccine (inactivated) ............................................... 815Poliomyelitis vaccine (inactivated), in vivo assay of (2.7.20.) .. 225Poliomyelitis vaccine (oral) ............................................................ 818Poliomyelitis vaccine (oral), test for neurovirulence (2.6.19.).. 179Poloxamers ......................................................................................2751Polyacrylate dispersion 30 per cent...........................................2752Polyamide 6/6 suture, sterile, in distributor for veterinary use.........................................................................................................1038
Polyamide 6 suture, sterile, in distributor for veterinary use.........................................................................................................1038
Polyethyleneglycols .......................................................................2402Polyethylene terephthalate for containers for preparations notfor parenteral use (3.1.15.) .......................................................... 357
Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use ..............................................................................1039
Poly(ethylene - vinyl acetate) for containers and tubing for totalparenteral nutrition preparations (3.1.7.)................................. 345
Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ......... 338
Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ......... 337
Polymorphism (5.9.) ........................................................................ 627Polymyxin B sulfate.......................................................................2753Polyolefines (3.1.3.) ......................................................................... 334Polyoxyl castor oil..........................................................................2398Polyoxyl hydrogenated castor oil ...............................................2397Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.)................ 342
Polysaccharide vaccines, hexosamines in (2.5.20.)................... 142Polysaccharide vaccines, methylpentoses in (2.5.21.).............. 143Polysaccharide vaccines, nucleic acids in (2.5.17.) ................... 142Polysaccharide vaccines, O-acetyl in (2.5.19.)............................ 142Polysaccharide vaccines, phosphorus in (2.5.18.)..................... 142Polysaccharide vaccines, protein in (2.5.16.) ..............................141Polysaccharide vaccines, ribose in (2.5.31.) ............................... 146Polysaccharide vaccines, sialic acid in (2.5.23.) ........................ 143Polysaccharide vaccines, uronic acids in (2.5.22.) .................... 143Polysorbate 20 ................................................................................2754Polysorbate 40 ................................................................................2755
3288 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.0 Index
Polysorbate 60 ................................................................................2756Polysorbate 80 ................................................................................2756Polystyrene sulfonate, sodium ....................................................2940Poly(vinyl acetate)..........................................................................2758Poly(vinyl acetate) dispersion 30 per cent ...............................2759Poly(vinyl alcohol) .........................................................................2760Poly(vinyl alcohol) macrogol grafted copolymer ....................2401Poly(vinyl chloride) (non-plasticised) for containers for drydosage forms for oral administration, materials based on(3.1.11.)............................................................................................. 350
Poly(vinyl chloride), non-plasticised, materials based on forcontainers for non-injectable aqueous solutions (3.1.10.).... 349
Poly(vinyl chloride), plasticised, empty sterile containers of forhuman blood and blood components (3.2.4.).......................... 370
Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ............................................................................................ 355
Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ........................................................................................... 329
Poly(vinyl chloride), plasticised, materials based on for tubingused in sets for the transfusion of blood and blood components(3.1.1.2.) ........................................................................................... 332
Poly(vinyl chloride), plasticised, sterile containers of for humanblood containing anticoagulant solution (3.2.5.) ................... 371
Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) ........................................................................... 299
Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.)..................................................................... 299
Powder fineness (2.9.35.) ............................................................... 308Powder flow (2.9.36.) ...................................................................... 308Powder flow (2.9.36.) (5.8.) ........................................................... 622Powders and granules for oral solutions and suspensions .... 718Powders and granules for syrups ................................................. 719Powders and tablets for rectal solutions and suspensions..... 733Powders, bulk density and tapped density of (2.9.34.) ............ 305Powders, ear...................................................................................... 710Powders, effervescent...................................................................... 727Powders for cutaneous application.............................................. 726Powders for eye drops and powders for eye lotions................. 711Powders for inhalation.................................................................... 730Powders for injections or infusions ............................................. 725Powders for oral drops.................................................................... 719Powders, nasal .................................................................................. 721Powders, oral .................................................................................... 727Powders, wettability of porous solids including (2.9.45.) ....... 321Pramipexole dihydrochloride monohydrate ............................2779Pravastatin sodium........................................................................2780Prazepam .........................................................................................2782Praziquantel ....................................................................................2783Prazosin hydrochloride ................................................................2784Prednicarbate..................................................................................2785Prednisolone ...................................................................................2786Prednisolone acetate.....................................................................2787Prednisolone pivalate....................................................................2789Prednisolone sodium phosphate ................................................2790Prednisone.......................................................................................2791Pregelatinised starch.....................................................................2983Prekallikrein activator (2.6.15.) .................................................... 175Premixes for medicated feeding stuffs for veterinary use....... 727Preparations for inhalation............................................................ 728Preparations for inhalation: aerodynamic assessment of fineparticles (2.9.18.) ........................................................................... 274
Preparations for irrigation............................................................. 731Pressurised pharmaceutical preparations .................................. 732Prilocaine.........................................................................................2792Prilocaine hydrochloride..............................................................2794Primaquine diphosphate ..............................................................2795Primary aromatic amino-nitrogen, determination of (2.5.8.) .. 139Primary standards for volumetric solutions (4.2.1.)................. 494Primidone ........................................................................................2796Primula root .................................................................................... 1217Probenecid.......................................................................................2797Procainamide hydrochloride .......................................................2798Procaine benzylpenicillin ............................................................. 1474Procaine hydrochloride ................................................................2798Prochlorperazine maleate ............................................................2799Products of fermentation ............................................................... 685Products of recombinant DNA technology ................................ 692Products with risk of transmitting agents of animal spongiformencephalopathies ........................................................................... 686
Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) ........................................................................... 232
RRabbit haemorrhagic disease vaccine (inactivated) ................. 933Rabies immunoglobulin, human ................................................ 2186Rabies vaccine for human use prepared in cell cultures......... 822Rabies vaccine (inactivated) for veterinary use......................... 934Rabies vaccine (live, oral) for foxes .............................................. 936Racecadotril ....................................................................................2841Racemic camphor...........................................................................1571Racemic ephedrine hydrochloride .............................................1928Racemic menthol ...........................................................................2445Raclopride ([11C]methoxy) injection............................................. 988Radionuclides, table of physical characteristics (5.7.) ............. 611Radiopharmaceutical preparations .............................................. 686Radiopharmaceutical preparations, iobenguane sulfate for ..982Radiopharmaceutical preparations, medronic acid for ........... 984Radiopharmaceutical preparations, pentetate sodium calciumfor ...................................................................................................... 987
Radiopharmaceutical preparations, tetra-O-acetyl-mannosetriflate for ......................................................................................1020
Raloxifene hydrochloride .............................................................2842Raman spectrometry (2.2.48.) ......................................................... 82Ramipril............................................................................................2843Ramon assay, flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (2.7.27.) .......................................................... 231
Ranitidine hydrochloride..............................................................2845Rapeseed oil, refined.....................................................................2847Reagents (4.) ..................................................................................... 379Reagents (4.1.1.) ............................................................................... 379Reagents, standard solutions, buffer solutions (4.1.)............... 379Recombinant DNA technology, products of .............................. 692
Recommendations on dissolution testing (5.17.1.) ................... 665Recommendations on methods for dosage forms testing(5.17.) ................................................................................................ 665
Rectal capsules ................................................................................. 733Rectal foams...................................................................................... 733Rectal preparations.......................................................................... 732Rectal preparations, semi-solid ..................................................... 733Rectal solutions and suspensions, powders and tablets for ... 732Rectal solutions, emulsions and suspensions............................ 733Rectal tampons................................................................................. 734Red poppy petals............................................................................1222Reference standards (5.12.) ........................................................... 641Refractive index (2.2.6.) .................................................................... 26Relationship between reaction of solution, approximate pH andcolour of certain indicators (2.2.4.) ............................................. 25
Relative density (2.2.5.)..................................................................... 25Repaglinide......................................................................................2847Reserpine .........................................................................................2849Residual solvents (5.4.) ................................................................... 583Residual solvents, identification and control (2.4.24.) ............ 123Residue on evaporation of essential oils (2.8.9.)....................... 240Resistance to crushing of tablets (2.9.8.) ................................... 267Resorcinol ........................................................................................2850Restharrow root .............................................................................1223Retroviridae-derived vectors for human use .............................. 654Rhatany root ...................................................................................1223Rhatany tincture ............................................................................1224Rhinotracheitis vaccine (inactivated), viral, feline .................... 901Rhinotracheitis vaccine (live), viral, feline.................................. 902Rhubarb ...........................................................................................1224Ribavirin...........................................................................................2850Riboflavin.........................................................................................2852Riboflavin sodium phosphate......................................................2853Ribose in polysaccharide vaccines (2.5.31.) ............................... 146Ribwort plantain ............................................................................1225Rice starch.......................................................................................2855Rifabutin ..........................................................................................2855Rifampicin........................................................................................2856Rifamycin sodium...........................................................................2858Rifaximin..........................................................................................2859Rilmenidine dihydrogen phosphate...........................................2861Risperidone .....................................................................................2861Ritonavir ..........................................................................................2863Rocuronium bromide ....................................................................2866Roman chamomile flower ............................................................1098Ropivacaine hydrochloride monohydrate.................................2868Roselle ..............................................................................................1226Rosemary leaf .................................................................................1227Rosemary oil ...................................................................................1228Rotating viscometer method - viscosity (2.2.10.) ........................ 28Rotation, optical (2.2.7.) ................................................................... 26Rotavirus vaccine (live, oral) ......................................................... 824Roxithromycin.................................................................................2869RRR-α-Tocopherol ......................................................................... 3105RRR-α-Tocopheryl acetate ........................................................... 3108RRR-α-Tocopheryl hydrogen succinate .................................... 3111Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) .............................................................................................. 374
Sieving, analytical, particle-size distribution estimation by(2.9.38.) (5.8.) ................................................................................. 623
SI (International System) units (1.) ..................................................3Silica, colloidal anhydrous ...........................................................2901Silica, colloidal hydrated ..............................................................2902Silica, dental type...........................................................................2903Silica, hydrophobic colloidal .......................................................2903Silicate, aluminium magnesium..................................................1358Silicate, aluminium sodium ......................................................... 1361Silicone elastomer for closures and tubing (3.1.9.) .................. 347Silicone oil used as a lubricant (3.1.8.) ....................................... 347Silk suture, sterile, braided, in distributor for veterinary use.........................................................................................................1039
Silver, colloidal, for external use ................................................2904Silver nitrate ...................................................................................2905Simeticone.......................................................................................2905Simvastatin......................................................................................2906Single-dose preparations, uniformity of content (2.9.6.)......... 266Single-dose preparations, uniformity of mass (2.9.5.).............. 265Sintered-glass filters (2.1.2.) ............................................................ 15
Soft extracts ...................................................................................... 676Solid dosage forms, dissolution test for (2.9.3.)........................ 256Solid dosage forms, recommendations on dissolution testing of(5.17.1.)............................................................................................. 665
Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.)................................................................. 299
Solids, density of (2.2.42.) ................................................................ 66Solids, gas pycnometric density of (2.9.23.)............................... 288Solids (porous) including powders, wettability of (2.9.45.) .... 321Solubility in alcohol of essential oils (2.8.10.) ........................... 240Soluble tablets .................................................................................. 737Solutions, emulsions and suspensions, oral .............................. 718Solutions for haemodialysis......................................................... 2136Solutions for haemodialysis, concentrated, water fordiluting........................................................................................... 2135
Solutions for haemofiltration and haemodiafiltration........... 2138Solutions for organ preservation................................................2952Solutions for peritoneal dialysis .................................................2695Solutions, suspensions, intrauterine ........................................... 715Solvents, residual (5.4.) .................................................................. 583Solvents, residual, identification and control (2.4.24.) ............ 123Somatostatin ...................................................................................2953Somatropin......................................................................................2954Somatropin concentrated solution ............................................2956Somatropin for injection ..............................................................2958Sorbic acid.......................................................................................2960Sorbitan laurate .............................................................................2961Sorbitan oleate ...............................................................................2961Sorbitan palmitate .........................................................................2962Sorbitan sesquioleate....................................................................2962Sorbitan stearate............................................................................2962Sorbitan trioleate ...........................................................................2963Sorbitol.............................................................................................2963Sorbitol, liquid (crystallising)......................................................2965Sorbitol, liquid (non-crystallising)..............................................2965Sorbitol, liquid, partially dehydrated.........................................2966Sotalol hydrochloride ...................................................................2967Soya-bean oil, hydrogenated........................................................2968Soya-bean oil, refined....................................................................2969Spanish sage oil..............................................................................1239Specific surface area by air permeability (2.9.14.).................... 271Specific surface area by gas adsorption (2.9.26.) ..................... 291Specific surface area by gas adsorption (2.9.26.) (5.8.)........... 622Spectinomycin dihydrochloride pentahydrate ........................2969Spectinomycin sulfate tetrahydrate for veterinary use .........2971Spectrometry, atomic absorption (2.2.23.)................................... 36Spectrometry, atomic emission (2.2.22.)....................................... 35Spectrometry, mass (2.2.43.) ........................................................... 67Spectrometry, nuclear magnetic resonance (2.2.33.) ................ 52Spectrometry, Raman (2.2.48.) ....................................................... 82Spectrometry, X-ray fluorescence (2.2.37.)................................... 58Spectrophotometry, infrared absorption (2.2.24.)...................... 38Spectrophotometry, near-infrared (2.2.40.)...................................61Spectrophotometry, ultraviolet and visible absorption(2.2.25.) .............................................................................................. 40
SPF chicken flocks for the production and quality control ofvaccines (5.2.2.) .............................................................................. 527
Spheroids and granules, friability of (2.9.41.)............................ 318Spike lavender oil ..........................................................................1240Spiramycin.......................................................................................2973Spirapril hydrochloride monohydrate.......................................2975Spironolactone ...............................................................................2976Spot-on preparations....................................................................... 740Sprays ................................................................................................. 740
Stavudine.........................................................................................2988Steam sterilisation of aqueous preparations, application of theF0 concept (5.1.5.).......................................................................... 508
Stearic acid......................................................................................2989Stearoyl macrogolglycerides .......................................................2990Stearyl alcohol................................................................................2991Stem cells, human haematopoietic ............................................ 2175Stephania root, fourstamen.........................................................1127Sterile braided silk suture in distributor for veterinary use ..1039Sterile catgut...................................................................................1027Sterile catgut in distributor for veterinary use .......................1037Sterile containers of plasticised poly(vinyl chloride) for humanblood containing anticoagulant solution (3.2.5.) ................... 371
Sterile linen thread in distributor for veterinary use ............1038Sterile non-absorbable strands in distributor for veterinaryuse...................................................................................................1039
Sterile non-absorbable sutures ...................................................1028Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ....................................................................... 369
Sterile polyamide 6/6 suture in distributor for veterinaryuse...................................................................................................1038
Sterile polyamide 6 suture in distributor for veterinaryuse...................................................................................................1038
Sterile poly(ethylene terephthalate) suture in distributor forveterinary use ...............................................................................1039
Sterile products, methods of preparation (5.1.1.) ..................... 503Sterile single-use plastic syringes (3.2.8.) ................................... 373Sterile synthetic absorbable braided sutures .......................... 1031Sterile synthetic absorbable monofilament sutures...............1033Sterilisation procedures, biological indicators (5.1.2.) ............ 504Sterility (2.6.1.) ................................................................................. 153Sterility, guidelines for using the test for (5.1.9.) ..................... 519Sterols in fatty oils (2.4.23.)........................................................... 121Sticks .................................................................................................. 736Sticks, intrauterine .......................................................................... 715Sticks, nasal....................................................................................... 721St. John’s wort................................................................................1241St. John’s wort dry extract, quantified......................................1242Stomata and stomatal index (2.8.3.) ............................................ 239Stramonium leaf.............................................................................1247Stramonium, prepared ..................................................................1248Strands, sterile non-absorbable, in distributor for veterinary use.........................................................................................................1039
Streptokinase concentrated solution ........................................2991Streptomycin sulfate .....................................................................2993Strontium (89Sr) chloride injection ............................................1003Subdivision of tablets...................................................................... 736Sublingual sprays, oromucosal drops and oromucosalsprays................................................................................................ 721
Sublingual tablets and buccal tablets ......................................... 723Substances for pharmaceutical use ............................................. 694
3292 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.0 Index
Substances for pharmaceutical use, control of impurities in(5.10.)................................................................................................ 631
Substances of animal origin for the production of immunologicalveterinary medicinal products (5.2.5.) ...................................... 535
Tablets and capsules, disintegration of (2.9.1.) ......................... 253Tablets, buccal .................................................................................. 723Tablets, coated.................................................................................. 737Tablets, dispersible .......................................................................... 737Tablets, effervescent ........................................................................ 737Tablets for intrauterine solutions and suspensions ................. 715Tablets for use in the mouth ......................................................... 738Tablets for vaginal solutions and suspensions .......................... 739Tablets, gastro-resistant.................................................................. 738Tablets, intrauterine ........................................................................ 715Tablets, modified-release ................................................................ 738Tablets, orodispersible .................................................................... 737Tablets, resistance to crushing (2.9.8.) ....................................... 267Tablets, soluble................................................................................. 737Tablets, subdivision of .................................................................... 736Tablets, sublingual........................................................................... 723Tablets, uncoated ............................................................................. 737Tablets, uncoated, friability of (2.9.7.) ......................................... 266Tablets, uncoated, friability of (2.9.7.) (5.8.) .............................. 622Tablets, vaginal................................................................................. 739Talc....................................................................................................3033Tamoxifen citrate ...........................................................................3034Tampons, ear..................................................................................... 710Tampons, medicated ....................................................................... 738Tampons, rectal ................................................................................ 734Tampons, vaginal, medicated ........................................................ 740Tamsulosin hydrochloride ...........................................................3036Tannic acid ......................................................................................3037Tannins in herbal drugs, determination of (2.8.14.) ................ 243Tapped density of powders, bulk density and (2.9.34.) ........... 305Tartaric acid ....................................................................................3038Teat dips............................................................................................. 740Tea tree oil ....................................................................................... 1251Teat sprays..........................................................................................741Technetium (99mTc) bicisate injection ........................................1004Technetium (99mTc) colloidal rhenium sulfide injection .......1005Technetium (99mTc) colloidal sulfur injection...........................1006Technetium (99mTc) colloidal tin injection ................................1006Technetium (99mTc) etifenin injection ........................................1007Technetium (99mTc) exametazime injection ..............................1008Technetium (99mTc) gluconate injection ....................................1009Technetium (99mTc) human albumin injection ......................... 1010Technetium (99mTc) macrosalb injection.................................... 1011Technetium (99mTc) mebrofenin injection ................................. 1012Technetium (99mTc) medronate injection................................... 1013Technetium (99mTc) mertiatide injection ................................... 1014Technetium (99mTc) microspheres injection.............................. 1015Technetium (99mTc) pentetate injection..................................... 1016Technetium (99mTc) sestamibi injection ..................................... 1017Technetium (99mTc) succimer injection...................................... 1018Technetium (99mTc) tin pyrophosphate injection..................... 1019Teicoplanin ......................................................................................3038Telmisartan......................................................................................3040Temazepam......................................................................................3042Tenosynovitis avian viral vaccine (live) ....................................... 861Tenoxicam........................................................................................3043Terazosin hydrochloride dihydrate ............................................3045Terbinafine hydrochloride............................................................3047Terbutaline sulfate.........................................................................3048Terconazole .....................................................................................3049Terfenadine......................................................................................3050Terminology used in monographs on biological products(5.2.1.)............................................................................................... 527
Test for anticomplementary activity of immunoglobulin(2.6.17.)............................................................................................. 177
Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ......................................... 191
Test for aristolochic acids in herbal drugs (2.8.21) .................. 247Test for extractable volume of parenteral preparations(2.9.17.)............................................................................................. 273
Test for extractable volume of parenteral preparations (2.9.17.)(5.8.).................................................................................................. 622
Test for Fc function of immunoglobulin (2.7.9.) ........................217
General Notices (1) apply to all monographs and other texts 3293
Index EUROPEAN PHARMACOPOEIA 7.0
Test for methanol and 2-propanol (2.9.11.) ................................ 270Test for neurovirulence of live virus vaccines (2.6.18.) ........... 179Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ............................................................................................ 179
Test for specified micro-organisms (microbiological examinationof non-sterile products) (2.6.13.) ................................................ 167
Test for specified micro-organisms (microbiological examinationof non-sterile products) (2.6.13.) (5.8.) ..................................... 622
Testosterone ....................................................................................3052Testosterone decanoate ................................................................3053Testosterone enantate...................................................................3054Testosterone isocaproate..............................................................3056Testosterone propionate...............................................................3057Tests for extraneous agents in viral vaccines for human use(2.6.16.) ............................................................................................ 176
Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ................................................... 231
Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s)content)............................................................................................ 752
Tetanus antitoxin for human use ................................................. 953Tetanus antitoxin for veterinary use............................................ 960Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed)........................................................................................ 753
Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed)......................................................................... 754
Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ......................................... 765
Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type b conjugatevaccine (adsorbed)......................................................................... 768
Tetanus, diphtheria, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)......................................................................... 771
Tetanus, diphtheria, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ................ 772
Tetanus immunoglobulin, human .............................................. 2187Tetanus vaccine (adsorbed) ........................................................... 833Tetanus vaccine (adsorbed), assay of (2.7.8.) ............................. 214Tetanus vaccine for veterinary use .............................................. 941Tetracaine hydrochloride .............................................................3058Tetracosactide.................................................................................3059Tetracycline .....................................................................................3060Tetracycline hydrochloride ..........................................................3061Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations..................................................................................1020
TSE, animal, products with risk of transmitting agents of..... 686Tuberculin for human use, old.................................................... 3159Tuberculin purified protein derivative, avian .......................... 3161Tuberculin purified protein derivative, bovine........................ 3161Tuberculin purified protein derivative for human use .......... 3162Tubes for comparative tests (2.1.5.) ................................................17Tubing and closures, silicone elastomer for (3.1.9.)................. 347Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ......... 345
Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinyl chloride)for (3.1.1.2.) ..................................................................................... 332
Tubocurarine chloride .................................................................. 3164Turmeric, Javanese ........................................................................1257Turpentine oil, Pinus pinaster type ...........................................1258Tylosin for veterinary use ............................................................ 3165Tylosin phosphate bulk solution for veterinary use .............. 3166Tylosin tartrate for veterinary use ............................................. 3168Typhoid polysaccharide vaccine ................................................... 836Typhoid vaccine................................................................................ 837Typhoid vaccine, freeze-dried........................................................ 837Typhoid vaccine (live, oral, strain Ty 21a).................................. 838Tyrosine............................................................................................ 3169Tyrothricin....................................................................................... 3170
UUbidecarenone................................................................................ 3175Udder-washes .....................................................................................741Ultraviolet and visible absorption spectrophotometry(2.2.25.) .............................................................................................. 40
Ultraviolet ray lamps for analytical purposes (2.1.3.)................. 15Uncoated tablets............................................................................... 737Undecylenic acid ............................................................................ 3176Uniformity of content of single-dose preparations (2.9.6.) ..... 266Uniformity of dosage units (2.9.40.) ............................................ 315Uniformity of mass of delivered doses from multidose containers(2.9.27.) ............................................................................................ 294
Uniformity of mass of single-dose preparations (2.9.5.) .......... 265Units of the International System (SI) used in the Pharmacopoeiaand equivalence with other units (1.).............................................3
VVaccines, adsorbed, aluminium in (2.5.13.).................................141Vaccines, adsorbed, calcium in (2.5.14.).......................................141Vaccines and immunosera, phenol in (2.5.15.) ...........................141Vaccines and immunosera, veterinary, evaluation of efficacy of(5.2.7.)............................................................................................... 538
Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) .............................................................................................. 536
Vaccines and immunosera, veterinary, evaluation of the safetyof each batch (5.2.9.)..................................................................... 547
Vaccines for human use.................................................................. 695Vaccines for human use, cell substrates for the production of(5.2.3.) .............................................................................................. 530
Vaccines for human use, viral, tests for extraneous agents in(2.6.16.) ............................................................................................ 176
Vaccines for veterinary use............................................................ 698Vaccines, polysaccharide, hexosamines in (2.5.20.).................. 142Vaccines, polysaccharide, methylpentoses in (2.5.21.)............. 143Vaccines, polysaccharide, nucleic acids in (2.5.17.) .................. 142Vaccines, polysaccharide, O-acetyl in (2.5.19.)........................... 142Vaccines, polysaccharide, phosphorus in (2.5.18.) ................... 142Vaccines, polysaccharide, protein in (2.5.16.) .............................141Vaccines, polysaccharide, ribose in (2.5.31.) .............................. 146Vaccines, polysaccharide, sialic acid in (2.5.23.) ....................... 143Vaccines, polysaccharide, uronic acids in (2.5.22.)................... 143Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) .......................................................................... 527
Vaccines, veterinary, cell cultures for the production of(5.2.4.) .............................................................................................. 533
Vaccines, viral live, test for neurovirulence (2.6.18.)................ 179Vaginal capsules ............................................................................... 739Vaginal foams.................................................................................... 740Vaginal preparations ....................................................................... 738Vaginal preparations, semi-solid ................................................... 740Vaginal solutions and suspensions, tablets for ......................... 739Vaginal solutions, emulsions and suspensions.......................... 739Vaginal tablets .................................................................................. 739Vaginal tampons, medicated.......................................................... 740Valaciclovir hydrochloride, anhydrous...................................... 3185Valerian dry aqueous extract .....................................................1259Valerian dry hydroalcoholic extract...........................................1260Valerian root....................................................................................1261Valerian root, cut............................................................................1262Valerian tincture.............................................................................1263Validation of nucleic acid amplification techniques forthe detection of B19 virus (B19V) DNA in plasma pools :guidelines ........................................................................................ 181
Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :guidelines ........................................................................................ 181
Valine ................................................................................................ 3188Valnemulin hydrochloride for veterinary use ......................... 3188Valproate, sodium ..........................................................................2951Valproic acid.................................................................................... 3190Valsartan .......................................................................................... 3191Vancomycin hydrochloride .......................................................... 3192Vanillin ............................................................................................. 3194Varicella immunoglobulin for intravenous administration,human ............................................................................................ 2189
Varicella immunoglobulin, human............................................. 2188Varicella, measles, mumps and rubella vaccine (live) .............. 799Varicella vaccine (live)..................................................................... 839Vectors for human use, adenovirus ............................................. 650Vectors for human use, plasmid ................................................... 648Vectors for human use, plasmid, bacterial cells used for themanufacture of ............................................................................... 649
Vectors for human use, poxvirus .................................................. 652Vecuronium bromide..................................................................... 3195Vedaprofen for veterinary use..................................................... 3196Vegetable fatty oils........................................................................... 703Venlafaxine hydrochloride ........................................................... 3197Verapamil hydrochloride .............................................................. 3198
General Notices (1) apply to all monographs and other texts 3294a
Index EUROPEAN PHARMACOPOEIA 7.0
Verbena herb...................................................................................1264Veterinary liquid preparations for cutaneous application ...... 740Veterinary medicinal products, immunological, substances ofanimal origin for the production of (5.2.5.) ............................. 535
Veterinary vaccines and immunosera, evaluation of efficacy of(5.2.7.)............................................................................................... 538
Viability, nucleated cell count and (2.7.29.) ............................... 233Vibriosis (cold-water) vaccine (inactivated) for salmonids ...... 943Vibriosis vaccine (inactivated) for salmonids............................. 944VICH (5.8.) ......................................................................................... 621Vinblastine sulfate .........................................................................3200Vincristine sulfate ..........................................................................3201Vindesine sulfate ............................................................................3202Vinorelbine tartrate .......................................................................3204Vinpocetine......................................................................................3206Viper venom antiserum, European .............................................. 953Viral rhinotracheitis vaccine (inactivated), feline...................... 901Viral rhinotracheitis vaccine (live), feline ................................... 902Viral safety (5.1.7.) ........................................................................... 518Viral vaccines for human use, tests for extraneous agents in(2.6.16.) ............................................................................................ 176
Xylazine hydrochloride for veterinary use ...............................3238Xylitol ................................................................................................3239Xylometazoline hydrochloride ....................................................3241Xylose................................................................................................3242
Aqua ad iniectabile ....................................................................... 3219Aquae (15O) solutio iniectabilis ..................................................1023Aquae tritiatae (3H) solutio iniectabilis ...................................1022Aqua purificata ..............................................................................3224Aqua valde purificata...................................................................3222Arachidis oleum hydrogenatum................................................ 1413Arachidis oleum raffinatum ....................................................... 1413Argenti nitras .................................................................................2905Argentum colloidale ad usum externum ................................2904Arginini aspartas .......................................................................... 1415Arginini hydrochloridum............................................................ 1415Argininum....................................................................................... 1414Argon ................................................................................................ 1416Arnicae flos.....................................................................................1053Arnicae tinctura ............................................................................1055Arsenii trioxidum ad praeparationes homoeopathicas ......1286Articaini hydrochloridum ........................................................... 1417Ascorbylis palmitas.......................................................................1420Asparaginum monohydricum.................................................... 1421Aspartamum ................................................................................... 1421Astragali mongholici radix .........................................................1060Atenololum......................................................................................1424Atracurii besilas.............................................................................1425Atropini sulfas................................................................................1429Atropinum .......................................................................................1427Aurantii amari epicarpii et mesocarpii tinctura ..................1078Aurantii amari epicarpium et mesocarpium.........................1077Aurantii amari flos .......................................................................1078
Aurantii dulcis aetheroleum.......................................................1249Auricularia........................................................................................ 709Azaperonum ad usum veterinarium........................................1430Azathioprinum............................................................................... 1431Azelastini hydrochloridum .........................................................1433Azithromycinum............................................................................1434
FFactor humanus von Willebrandi ............................................. 2189Factor IX coagulationis humanus ............................................ 2172Factor VII coagulationis humanus .......................................... 2169Factor VIII coagulationis humanus......................................... 2170Factor VIII coagulationis humanus (ADNr) .......................... 2171Factor XI coagulationis humanus ............................................ 2173Fagopyri herba ..............................................................................1084Famotidinum..................................................................................1995Febantelum ad usum veterinarium..........................................1996Felbinacum .....................................................................................1997Felodipinum ...................................................................................1998Felypressinum................................................................................1999Fenbendazolum ad usum veterinarium..................................2000Fenbufenum....................................................................................2001Fenofibratum..................................................................................2002Fenoteroli hydrobromidum ........................................................2003Fentanyli citras ..............................................................................2006Fentanylum.....................................................................................2005Fenticonazoli nitras .....................................................................2007Ferri chloridum hexahydricum.................................................2008Ferrosi fumaras .............................................................................2009Ferrosi gluconas ............................................................................ 2010Ferrosi sulfas desiccatus ............................................................. 2011Ferrosi sulfas heptahydricus ...................................................... 2012Ferrum ad praeparationes homoeopathicas .........................1294Fexofenadini hydrochloridum ................................................... 2013Fibrini glutinum............................................................................ 2014Fibrinogenum humanum ........................................................... 2174Fila non resorbilia sterilia ..........................................................1028Fila non resorbilia sterilia in fuso ad usum veterinarium ..1039Fila resorbilia synthetica monofilamenta sterilia ................1033Fila resorbilia synthetica torta sterilia .................................... 1031
Filgrastimi solutio concentrata ................................................. 2015Filipendulae ulmariae herba ..................................................... 1182Filum bombycis tortum sterile in fuso ad usumveterinarium ................................................................................1039
Filum ethyleni polyterephthalici sterile in fuso ad usumveterinarium ................................................................................1039
Filum lini sterile in fuso ad usum veterinarium ..................1038Filum polyamidicum-6/6 sterile in fuso ad usumveterinarium ................................................................................1038
Filum polyamidicum-6 sterile in fuso ad usumveterinarium ................................................................................1038
Immunoglobulinum humanum anti-D.................................... 2166Immunoglobulinum humanum anti-D ad usumintravenosum ............................................................................... 2167
Immunoglobulinum humanum hepatitidis A ....................... 2176Immunoglobulinum humanum hepatitidis B ....................... 2176Immunoglobulinum humanum hepatitidis B ad usumintravenosum ............................................................................... 2176
Immunosera ad usum veterinarium .......................................... 680Immunosera ex animale ad usum humanum ......................... 678Immunoserum botulinicum ......................................................... 949
General Notices (1) apply to all monographs and other texts 3301
Index EUROPEAN PHARMACOPOEIA 7.0
Immunoserum Clostridii novyi alpha ad usumveterinarium .................................................................................. 957
Immunoserum Clostridii perfringentis beta ad usumveterinarium .................................................................................. 958
Immunoserum Clostridii perfringentis epsilon ad usumveterinarium .................................................................................. 959
Tuberculinum pristinum ad usum humanum ...................... 3159Tubocurarini chloridum.............................................................. 3164
3308 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.0 Index
Tylosini phosphatis solutio ad usum veterinarium ............. 3166Tylosini tartras ad usum veterinarium ................................... 3168Tylosinum ad usum veterinarium ............................................ 3165Tyrosinum....................................................................................... 3169Tyrothricinum................................................................................ 3170
Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)adsorbatum..................................................................................... 753
Vaccinum diphtheriae, tetani et pertussis adsorbatum ........ 755Vaccinum diphtheriae, tetani et pertussis sine cellulis exelementis praeparatum adsorbatum........................................ 754
Vaccinum diphtheriae, tetani et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum...................................... 756
Vaccinum diphtheriae, tetani, pertussis et poliomyelitidisinactivatum adsorbatum ............................................................. 771
Vaccinum diphtheriae, tetani, pertussis, poliomyelitidisinactivatum et haemophili stirpi b coniugatumadsorbatum..................................................................................... 772
Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum et hepatitidis B (ADNr)adsorbatum ..................................................................................... 760
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatumadsorbatum ..................................................................................... 762
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum...................................... 763
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, hepatitidis B (ADNr), poliomyelitidisinactivatum et haemophili stirpi b coniugatumadsorbatum ..................................................................................... 765
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, poliomyelitidis inactivatum ethaemophili stirpi b coniugatum adsorbatum........................ 768
Vaccinum haemophili stirpi b coniugatum ............................. 776Vaccinum hepatitidis A inactivatum adsorbatum .................. 780Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)adsorbatum ..................................................................................... 779
Vaccinum hepatitidis A inactivatum virosomale .................... 781Vaccinum hepatitidis B (ADNr)................................................... 784Vaccinum hepatitidis viralis anatis stirpe I vivum ................ 889Vaccinum herpesviris equini inactivatum ............................... 892Vaccinum inactivatum diarrhoeae vituli coronaviroillatae ............................................................................................... 868
Vaccinum pertussis sine cellulis ex elementis praeparatumadsorbatum..................................................................................... 806