EUROPEAN PHARMACOPOEIA 5.8 INDEX To aid users the index includes a reference to the supplement where the latest version of a text can be found. For example: Acetone...............................................5.1-2875 means the monograph Acetone can be found on page 2875 of Supplement 5.1. Note that where no reference for a supplement is made, the text can be found in the principal volume. Monographs deleted from the 5 th edition are not included in the index; the list of deleted texts is found in the Contents of this supplement, page xxxviii. General Notices (1) apply to all monographs and other texts 5393
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EUROPEAN PHARMACOPOEIA 5.8 INDEX - 医药招商 药 … · · 2007-02-102.9.17. Test for extractable volume of parenteral preparations.....5.3-3363 2.9.18. Preparations for inhalation:
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EUROPEAN PHARMACOPOEIA 5.8
INDEXTo aid users the index includes a reference to the supplement where the latest version of a text can be found.
For example: Acetone...............................................5.1-2875
means the monograph Acetone can be found on page 2875 of Supplement 5.1.
Note that where no reference for a supplement is made, the text can be found in the principal volume.
Monographs deleted from the 5th edition are not included in the index; the list of deleted texts is found in the Contentsof this supplement, page xxxviii.
General Notices (1) apply to all monographs and other texts 5393
EUROPEAN PHARMACOPOEIA 5.8
5394 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.8 Index
Numerics1. General notices .............................................................5.6-43732.1.1. Droppers ..............................................................................172.1.2. Comparative table of porosity of sintered-glassfilters..............................................................................................17
2.1.3. Ultraviolet ray lamps for analytical purposes..............172.1.4. Sieves ...................................................................................182.1.5. Tubes for comparative tests ............................................192.1.6. Gas detector tubes.............................................................192.1. Apparatus ...............................................................................172.2.10. Viscosity - Rotating viscometer method .........5.3-33372.2.11. Distillation range ............................................................ 302.2.12. Boiling point ....................................................................312.2.13. Determination of water by distillation....................... 322.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ...................... 332.2.16. Melting point - instantaneous method ...................... 332.2.17. Drop point ........................................................................ 332.2.18. Freezing point................................................................. 342.2.19. Amperometric titration ................................................. 342.2.1. Clarity and degree of opalescence of liquids...5.7-47772.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry...................................................................... 352.2.22. Atomic emission spectrometry .................................... 352.2.23. Atomic absorption spectrometry ................................ 362.2.24. Absorption spectrophotometry, infrared .................. 372.2.25. Absorption spectrophotometry, ultraviolet andvisible.................................................................................5.6-4383
2.2.26. Paper chromatography ................................................. 402.2.27. Thin-layer chromatography ...............................5.2-30902.2.28. Gas chromatography ..................................................... 422.2.29. Liquid chromatography ................................................ 432.2.2. Degree of coloration of liquids...................................... 242.2.30. Size-exclusion chromatography .................................. 452.2.31. Electrophoresis ............................................................... 452.2.32. Loss on drying ................................................................ 502.2.33. Nuclear magnetic resonance spectrometry ...............512.2.34. Thermal analysis............................................................. 522.2.35. Osmolality ........................................................................ 542.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes....................... 55
2.2.37. X-ray fluorescence spectrometry................................. 562.2.38. Conductivity .........................................................5.1-27832.2.39. Molecular mass distribution in dextrans .................. 572.2.3. Potentiometric determination of pH............................ 262.2.40. Near-infrared spectrophotometry ............................... 592.2.41. Circular dichroism.......................................................... 632.2.42. Density of solids ............................................................. 642.2.43. Mass spectrometry ......................................................... 652.2.44. Total organic carbon in water for pharmaceuticaluse................................................................................................. 68
2.2.45. Supercritical fluid chromatography........................... 682.2.46. Chromatographic separation techniques.................. 692.2.47. Capillary electrophoresis ...............................................742.2.48. Raman spectrometry ..................................................... 792.2.49. Falling ball viscometer method................................... 802.2.4. Relationship between reaction of solution,approximate pH and colour of certain indicators .............. 27
2.3.2. Identification of fatty oils by thin-layerchromatography......................................................................... 98
2.3.3. Identification of phenothiazines by thin-layerchromatography......................................................................... 99
2.3.4. Odour .................................................................................. 992.3. Identification......................................................................... 952.4.10. Lead in sugars............................................................... 1072.4.11. Phosphates..................................................................... 1082.4.12. Potassium....................................................................... 1082.4.13. Sulphates ....................................................................... 1082.4.14. Sulphated ash ......................................................5.6-43892.4.15. Nickel in polyols ........................................................... 1082.4.16. Total ash......................................................................... 1082.4.17. Aluminium...................................................................... 1082.4.18. Free formaldehyde ....................................................... 1092.4.19. Alkaline impurities in fatty oils ................................. 1092.4.1. Ammonium....................................................................... 1032.4.21. Foreign oils in fatty oils by thin-layerchromatography....................................................................... 109
2.4.22. Composition of fatty acids by gas chromato-graphy ...............................................................................5.6-4389
2.4.23. Sterols in fatty oils ..............................................5.1-27872.4.24. Identification and control of residual solvents...... 1132.4.25. Ethylene oxide and dioxan..........................................1182.4.26. N,N-Dimethylaniline .....................................................1192.4.27. Heavy metals in herbal drugs and fatty oils ............1192.4.28. 2-Ethylhexanoic acid ................................................... 1202.4.29. Composition of fatty acids in oils rich inomega-3-acids...................................................................5.5-4107
2.4.2. Arsenic .............................................................................. 1032.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ........................................................................5.2-3095
2.4.31. Nickel in hydrogenated vegetable oils ............5.7-47812.4.32. Total cholesterol in oils rich in omega-3acids...................................................................................5.8-5197
2.4.3. Calcium............................................................................. 1032.4.4. Chlorides .......................................................................... 1042.4.5. Fluorides .......................................................................... 1042.4.6. Magnesium....................................................................... 1042.4.7. Magnesium and alkaline-earth metals ....................... 1042.4.8. Heavy metals ................................................................... 1042.4.9. Iron .................................................................................... 1072.4. Limit tests ............................................................................ 1032.5.10. Oxygen-flask method................................................... 1302.5.11. Complexometric titrations.......................................... 1302.5.12. Water : semi-micro determination....................5.7-47852.5.13. Aluminium in adsorbed vaccines...............................1312.5.14. Calcium in adsorbed vaccines ....................................1312.5.15. Phenol in immunosera and vaccines ........................1312.5.16. Protein in polysaccharide vaccines ...........................1312.5.17. Nucleic acids in polysaccharide vaccines ................ 1322.5.18. Phosphorus in polysaccharide vaccines.................. 1322.5.19. O-Acetyl in polysaccharide vaccines......................... 1322.5.1. Acid value................................................................5.2-30992.5.20. Hexosamines in polysaccharide vaccines................ 1322.5.21. Methylpentoses in polysaccharide vaccines ........... 1332.5.22. Uronic acids in polysaccharide vaccines ................. 1332.5.23. Sialic acid in polysaccharide vaccines ..................... 1332.5.24. Carbon dioxide in gases.............................................. 1342.5.25. Carbon monoxide in gases ......................................... 1342.5.26. Nitrogen monoxide and nitrogen dioxide ingases ........................................................................................... 135
2.5.27. Oxygen in gases ............................................................ 1362.5.28. Water in gases............................................................... 1362.5.29. Sulphur dioxide ............................................................ 1362.5.2. Ester value ....................................................................... 1272.5.30. Oxidising substances................................................... 1372.5.31. Ribose in polysaccharide vaccines............................ 1372.5.32. Water: micro determination ...................................... 137
General Notices (1) apply to all monographs and other texts 5395
Index EUROPEAN PHARMACOPOEIA 5.8
2.5.33. Total protein.................................................................. 1382.5.34. Acetic acid in synthetic peptides ...............................1412.5.35. Nitrous oxide in gases ..................................................1412.5.36. Anisidine value ............................................................. 1422.5.3. Hydroxyl value ................................................................ 1272.5.4. Iodine value ..................................................................... 1272.5.5. Peroxide value................................................................. 1282.5.6. Saponification value ...................................................... 1292.5.7. Unsaponifiable matter ................................................... 1292.5.8. Determination of primary aromaticamino-nitrogen ......................................................................... 129
2.5.9. Determination of nitrogen by sulphuric aciddigestion .................................................................................... 129
2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ..............................5.6-4404
2.6.14. Bacterial endotoxins .....................................................1612.6.15. Prekallikrein activator........................................5.5-41112.6.16. Tests for extraneous agents in viral vaccines forhuman use................................................................................. 169
2.6.17. Test for anticomplementary activity ofimmunoglobulin....................................................................... 170
2.6.18. Test for neurovirulence of live virus vaccines........ 1722.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ........................................................................................... 172
2.6.1. Sterility ............................................................................. 1452.6.20. Anti-A and anti-B haemagglutinins(indirect method) ......................................................................174
2.6.25. Avian live virus vaccines : tests for extraneous agentsin batches of finished product .....................................5.3-3345
2.6.26. Test for anti-D antibodies in human immunoglobulinfor intravenous administration ....................................5.3-3348
2.6.27. Microbiological control of cellular products ..5.6-44142.6.2. Mycobacteria ................................................................... 1492.6.7. Mycoplasmas...........................................................5.8-52012.6.8. Pyrogens........................................................................... 1522.6.9. Abnormal toxicity ........................................................... 1532.6. Biological tests ................................................................... 1452.7.10. Assay of human coagulation factor VII ..........5.6-44192.7.11. Assay of human coagulation factor IX ............5.5-41202.7.12. Assay of heparin in coagulation factors .................. 2042.7.13. Assay of human anti-D immunoglobulin................. 2052.7.14. Assay of hepatitis A vaccine ..............................5.1-27952.7.15. Assay of hepatitis B vaccine (rDNA)......................... 2072.7.16. Assay of pertussis vaccine (acellular)....................... 2082.7.17. Assay of human antithrombin III .............................. 2092.7.18. Assay of human coagulation factor II ...................... 2092.7.19. Assay of human coagulation factor X .......................2102.7.1. Immunochemical methods ........................................... 1872.7.20. In vivo assay of poliomyelitis vaccine(inactivated) .....................................................................5.6-4420
2.7.21. Assay of human von Willebrand factor...........5.5-41202.7.22. Assay of human coagulation factor XI............5.5-41212.7.23. Numeration of CD34/CD45+ cells in haematopoieticproducts ............................................................................5.6-4421
2.7.24. Flow cytometry ....................................................5.6-44232.7.27. Flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (Ramon assay)...............................5.6-4424
2.7.2. Microbiological assay of antibiotics ............................ 1882.7.4. Assay of human coagulation factor VIII ...........5.5-41192.7.5. Assay of heparin.....................................................5.6-4419
2.7.6. Assay of diphtheria vaccine (adsorbed) ............5.7-47892.7.7. Assay of pertussis vaccine............................................. 1972.7.8. Assay of tetanus vaccine (adsorbed)..................5.7-47932.7.9. Test for Fc function of immunoglobulin ................... 2022.7. Biological assays ................................................................ 1872.8.10. Solubility in alcohol of essential oils ........................2162.8.11. Assay of 1,8-cineole in essential oils .........................2162.8.12. Determination of essential oils in vegetabledrugs............................................................................................217
2.8.13. Pesticide residues..........................................................2182.8.14. Determination of tannins in herbal drugs .............. 2212.8.15. Bitterness value ............................................................ 2212.8.16. Dry residue of extracts................................................ 2222.8.17. Loss on drying of extracts .......................................... 2222.8.18. Determination of aflatoxin B1 in herbaldrugs..................................................................................5.7-4801
2.8.1. Ash insoluble in hydrochloric acid ............................. 2152.8.2. Foreign matter ................................................................ 2152.8.3. Stomata and stomatal index ........................................ 2152.8.4. Swelling index ................................................................. 2152.8.5. Water in essential oils.....................................................2162.8.6. Foreign esters in essential oils .....................................2162.8.7. Fatty oils and resinified essential oils in essentialoils................................................................................................216
2.8.8. Odour and taste of essential oils..................................2162.8.9. Residue on evaporation of essential oils ....................2162.8. Methods in pharmacognosy ............................................ 2152.9.10. Ethanol content and alcoholimetric tables ............ 2372.9.11. Test for methanol and 2-propanol ...................5.3-33622.9.12. Sieve test ........................................................................ 2392.9.14. Specific surface area by air permeability ................ 2392.9.15. Apparent volume .......................................................... 2412.9.16. Flowability...................................................................... 2422.9.17. Test for extractable volume of parenteralpreparations .....................................................................5.3-3363
2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles ...............................................................5.2-3103
2.9.19. Particulate contamination : sub-visible particles... 2532.9.1. Disintegration of tablets and capsules..............5.3-33512.9.20. Particulate contamination : visible particles .......... 2552.9.22. Softening time determination of lipophilicsuppositories............................................................................. 256
2.9.23. Pycnometric density of solids.................................... 2572.9.24. Resistance to rupture of suppositories andpessaries .................................................................................... 258
2.9.25. Dissolution test for medicated chewinggums .................................................................................. 5.2-3116
2.9.26. Specific surface area by gas adsorption.........5.1-28112.9.27. Uniformity of mass of delivered doses from multidosecontainers.................................................................................. 263
2.9.28. Test for deliverable mass or volume of liquid andsemi-solid preparations........................................................... 263
2.9.29. Intrinsic dissolution............................................5.4-37052.9.2. Disintegration of suppositories and pessaries ......... 2272.9.31. Particle size analysis by laser lightdiffraction .........................................................................5.6-4429
2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD)................5.6-4432
2.9.36. Powder flow..........................................................5.3-33632.9.37. Optical microscopy..............................................5.3-33662.9.38. Particle-size distribution estimation by analyticalsieving ...............................................................................5.3-3368
2.9.3. Dissolution test for solid dosage forms ............5.7-48052.9.40. Uniformity of dosage units................................5.3-33702.9.42. Dissolution test for lipophilic solid dosageforms..................................................................................5.3-3373
2.9.43. Apparent dissolution ..........................................5.6-44382.9.4. Dissolution test for transdermal patches .................. 2312.9.5. Uniformity of mass of single-dose preparations....... 233
5396 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.8 Index
2.9.6. Uniformity of content of single-dose preparations.. 2342.9.7. Friability of uncoated tablets ..............................5.2-31032.9.8. Resistance to crushing of tablets................................ 2352.9.9. Measurement of consistency by penetrometry ........ 2352.9. Pharmaceutical technical procedures ........................... 2253.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ...... 289
3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for dry dosage forms for oraladministration .......................................................................... 291
3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components....... 269
3.1.1.2. Materials based on plasticised poly(vinyl chloride)for tubing used in sets for the transfusion of blood andblood components ................................................................... 272
3.1.13. Plastic additives ............................................................ 2933.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion ...................................................................................... 296
3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use..................................... 298
3.1.1. Materials for containers for human blood and bloodcomponents............................................................................... 269
3.1.3. Polyolefines...................................................................... 2743.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 278
3.1.5. Polyethylene with additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 279
3.1.6. Polypropylene for containers and closures forparenteral preparations and ophthalmic preparations ... 282
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ........................ 285
3.1.8. Silicone oil used as a lubricant ................................... 2873.1.9. Silicone elastomer for closures and tubing .............. 2883.1. Materials used for the manufacture of containers ..... 2693.2.1. Glass containers for pharmaceutical use .................. 3033.2.2.1. Plastic containers for aqueous solutions forparenteral infusion .................................................................. 309
3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................... 308
3.2.3. Sterile plastic containers for human blood and bloodcomponents............................................................................... 309
3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components...........311
3.2.5. Sterile containers of plasticised poly (vinyl chloride)for human blood containing anticoagulant solution....... 312
3.2.6. Sets for the transfusion of blood and bloodcomponents................................................................................313
3.2.8. Sterile single-use plastic syringes ................................3143.2.9. Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders ..316
3.2. Containers ..................................................................5.6-44434.1.1. Reagents ..................................................................5.7-48174.1.1. Reagents ..................................................................5.8-52094.1.2. Standard solutions for limit tests.......................5.7-49284.1.2. Standard solutions for limit tests.......................5.8-52094.1.3. Buffer solutions .....................................................5.7-49324.1. Reagents, standard solutions, buffer solutions ..5.7-48174.2.1. Primary standards for volumetric solutions....5.7-49374.2.2. Volumetric solutions.............................................5.7-49384.2. Volumetric analysis...................................................5.7-49374. Reagents.........................................................................5.7-48175.10. Control of impurities in substances for pharmaceuticaluse......................................................................................5.5-4145
5.11. Characters section in monographs .............................. 5655.1.1. Methods of preparation of sterile products .............. 4455.1.2. Biological indicators of sterilisation........................... 447
5.12. Reference standards...............................................5.6-44555.1.3. Efficacy of antimicrobial preservation ....................... 4475.14. Gene transfer medicinal products for humanuse......................................................................................5.6-4461
5.1.4. Microbiological quality of pharmaceuticalpreparations .....................................................................5.6-4451
5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ....................................................5.1-2821
5.1.6. Alternative methods for control of microbiologicalquality................................................................................5.5-4131
5.1.7. Viral safety...............................................................5.8-52135.1. General texts on sterility .................................................. 4455.2.1. Terminology used in monographs on vaccines ....... 4535.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines...............5.1-2825
5.2.3. Cell substrates for the production of vaccines forhuman use................................................................................. 455
5.2.4. Cell cultures for the production of veterinaryvaccines...................................................................................... 458
5.2.5. Substances of animal origin for the production ofveterinary vaccines.................................................................. 460
5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ....................................................................5.1-2827
5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .....................................................................5.1-2829
5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ..................................................................................... 463
5.2.9. Evaluation of safety of each batch of veterinaryvaccines and immunosera.............................................5.1-2830
5.2. General texts on vaccines................................................. 4535.3. Statistical analysis of results of biological assays andtests............................................................................................. 475
5.4. Residual solvents ............................................................... 5075.5. Alcoholimetric tables .........................................................5195.6. Assay of interferons..................................................5.3-33815.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia..................... 539
Animal immunosera for human use..............................5.8-5222Animal spongiform encephalopathies, products with risk oftransmitting agents of............................................................. 577
Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 463
General Notices (1) apply to all monographs and other texts 5399
Index EUROPEAN PHARMACOPOEIA 5.8
Anisi stellati aetheroleum .....................................................2488Anisi stellati fructus.........................................................5.5-4297Antazoline hydrochloride....................................................... 1006Antazolini hydrochloridum.................................................. 1006Anthrax spore vaccine (live) for veterinary use................... 715Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates) ..............................................................5.6-4479
Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) .......................................................................................174
Antibiotics, microbiological assay of (2.7.2.) ........................ 188Antibodies for human use, monoclonal .......................5.8-5224Anticoagulant and preservative solutions for human blood................................................................................................... 1007
Anticomplementary activity of immunoglobulin (2.6.17.).. 170Anticorpora monoclonalia ad usum humanum ......5.8-5224Anti-D antibodies in human immunoglobulins for intravenousadministration, test for (2.6.26.) ..................................5.3-3348
Anti-D immunoglobulin, human ....................................5.6-4595Anti-D immunoglobulin, human, assay of (2.7.13.)............. 205Anti-D immunoglobulin, human, for intravenousadministration .................................................................5.6-4595
Antimicrobial preservation, efficacy of (5.1.3.) .................... 447Antiserum, European viper venom ........................................ 806Antithrombin III concentrate, human ................................. 1733Antithrombin III, human, assay of (2.7.17.) .......................... 209Antithrombinum III humanum densatum ....................... 1733Anti-T lymphocyte immunoglobulin for human use,animal................................................................................5.6-4506
Apis mellifera ad praeparationes homoeopathicas.......... 898Apomorphine hydrochloride ..................................................1014Apomorphini hydrochloridum .............................................1014Apparatus (2.1.) .............................................................................17Apparent dissolution (2.9.43.) ........................................5.6-4438Apparent volume (2.9.15.)........................................................ 241Application of the F0 concept to steam sterilisation ofaqueous preparations (5.1.5.).......................................5.1-2821
Ascorbic acid ......................................................................5.6-4511Ascorbylis palmitas..........................................................5.6-4512Ascorbyl palmitate ............................................................5.6-4512Ash insoluble in hydrochloric acid (2.8.1.) ........................... 215Ash leaf....................................................................................... 1026Asparagine monohydrate .......................................................1027Asparaginum monohydricum.............................................. 1027Aspartame.................................................................................. 1028Aspartamum ............................................................................. 1028Aspartic acid.............................................................................. 1029Assay of 1,8-cineole in essential oils (2.8.11.) .......................216Assay of diphtheria vaccine (adsorbed) (2.7.6.) ..........5.7-4789Assay of heparin (2.7.5.) ..................................................5.6-4419Assay of heparin in coagulation factors (2.7.12.) ................ 204Assay of hepatitis A vaccine (2.7.14.) ............................5.1-2795Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 207Assay of human anti-D immunoglobulin (2.7.13.)............... 205Assay of human antithrombin III (2.7.17.) ............................ 209Assay of human coagulation factor II (2.7.18.).................... 209Assay of human coagulation factor IX (2.7.11.)..........5.5-4120Assay of human coagulation factor VII (2.7.10.) ........5.6-4419Assay of human coagulation factor VIII (2.7.4.).........5.5-4119Assay of human coagulation factor X (2.7.19.) .....................210Assay of human coagulation factor XI (2.7.22.) .........5.5-4121Assay of human von Willebrand factor (2.7.21.) ........5.5-4120Assay of interferons (5.6.)................................................5.3-3381Assay of pertussis vaccine (2.7.7.)........................................... 197Assay of pertussis vaccine (acellular) (2.7.16.) .................... 208Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .............................................................................5.6-4420
Avian paramyxovirus 3 vaccine (inactivated)....................... 728Avian tuberculin purified protein derivative...............5.7-5129Avian viral tenosynovitis vaccine (live).................................. 729Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .............................................................................5.4-3699
Azaperone for veterinary use ................................................ 1036Azaperonum ad usum veterinarium..................................1036
5400 See the information section on general monographs (cover pages)
BBacampicillin hydrochloride.................................................. 1043Bacampicillini hydrochloridum.......................................... 1043Bacitracin................................................................................... 1045Bacitracinum............................................................................ 1045Bacitracinum zincum ............................................................ 1047Bacitracin zinc .......................................................................... 1047Baclofen ..................................................................................... 1050Baclofenum............................................................................... 1050Bacterial cells used for the manufacture of plasmid vectorsfor human use .................................................................5.6-4468
General Notices (1) apply to all monographs and other texts 5401
Index EUROPEAN PHARMACOPOEIA 5.8
Bismuthi subgallas ................................................................. 1106Bismuthi subnitras ponderosum......................................... 1107Bismuthi subsalicylas ............................................................ 1107Bismuth subcarbonate............................................................ 1105Bismuth subgallate.................................................................. 1106Bismuth subnitrate, heavy ..................................................... 1107Bismuth subsalicylate ............................................................. 1107Bitter fennel ..............................................................................1580Bitter-fennel fruit oil................................................................ 1108Bitterness value (2.8.15.).......................................................... 221Bitter-orange epicarp and mesocarp.................................... 1110Bitter-orange-epicarp and mesocarp tincture .................... 1110Bitter-orange flower .................................................................1111Bitter-orange-flower oil ....................................................5.3-3562Black horehound ..................................................................... 1113Bleomycini sulfas .............................................................5.2-3179Bleomycin sulphate ..........................................................5.2-3179Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ..........................311
Blood and blood components, materials for containers for(3.1.1.)......................................................................................... 269
Blood and blood components, sets for the transfusion of(3.2.6.) .........................................................................................313
Blood and blood components, sterile plastic containers for(3.2.3.) ........................................................................................ 309
Blood, anticoagulant and preservative solutions for .......1007Blood, sterile containers of plasticised poly (vinyl chloride)containing anticoagulant solution (3.2.5.) ......................... 312
Bogbean leaf ............................................................................. 1115Boiling point (2.2.12.) ..................................................................31Boldi folium .......................................................................5.3-3450Boldo leaf............................................................................5.3-3450Borage (starflower) oil, refined......................................5.1-2889Borago officinalis oleum raffinatum ..........................5.1-2889Borax .......................................................................................... 1116Boric acid....................................................................................1117Botulinum antitoxin .................................................................. 801Botulinum toxin type A for injection....................................1117Bovine infectious rhinotracheitis vaccine (live),freeze-dried................................................................................ 768
Cell substrates for the production of vaccines for human use(5.2.3.) ........................................................................................ 455
Cellulae stirpes haematopoieticae humanae............5.6-4598Cellular products, microbiological control of(2.6.27.) .............................................................................5.6-4414
Characters section in monographs (5.11.)............................ 565Charcoal, activated ..................................................................1246Chelidonii herba...................................................................... 1690Chenodeoxycholic acid ..........................................................1247Chewing gum, medicated, dissolution test for(2.9.25.) .............................................................................5.2-3116
Chewing gums, medicated ..............................................5.2-3136Chicken flocks free from specified pathogens forthe production and quality control of vaccines(5.2.2.) ...............................................................................5.1-2825
Clostridium botulinum vaccine for veterinary use ............. 745Clostridium chauvoei vaccine for veterinary use................ 745Clostridium novyi alpha antitoxin for veterinary use ........5.1-2865
Clostridium novyi (type B) vaccine for veterinary use....... 746
General Notices (1) apply to all monographs and other texts 5405
Index EUROPEAN PHARMACOPOEIA 5.8
Clostridium perfringens beta antitoxin for veterinary use............................................................................................5.1-2866
Clostridium perfringens epsilon antitoxin for veterinary use............................................................................................5.1-2867
Clostridium perfringens vaccine for veterinary use ........... 747Clostridium septicum vaccine for veterinary use................ 749Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 282
Closures and containers for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 308
Closures and tubing, silicone elastomer for (3.1.9.) ........... 288Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) .........................................................................................316
Colloidal anhydrous silica ...................................................... 2410Colloidal anhydrous silica, hydrophobic......................5.8-5362Colloidal hydrated silica ......................................................... 2411Colloidal silver, for external use ....................................5.3-3613Colophonium ...........................................................................1362Colophony .................................................................................1362Coloration of liquids (2.2.2.)...................................................... 24Common stinging nettle for homoeopathicpreparations .....................................................................5.3-3429
Comparative table of porosity of sintered-glass filters(2.1.2.)............................................................................................17
Complexometric titrations (2.5.11.)........................................ 130Composition of fatty acids by gas chromatography(2.4.22.) .............................................................................5.6-4389
Composition of fatty acids in oils rich in omega-3-acids(2.4.29.) .............................................................................5.5-4107
Compressed lozenges.......................................................5.4-3846Compressi...........................................................................5.8-5239Concentrated solutions for haemodialysis ......................... 1700Concentrates for injections or infusions......................5.2-3145Concentrates for intrauterine solutions.......................5.3-3397Conductivity (2.2.38.) .......................................................5.1-2783Coneflower herb, purple .................................................5.7-5098Coneflower root, narrow-leaved.....................................5.7-5064Coneflower root, pale.......................................................5.7-5085Coneflower root, purple ..................................................5.7-5100Conjugated estrogens .............................................................1539Containers (3.2.)................................................................5.6-4443Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 282
Containers and closures for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 308
Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285
Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ...................................................................................... 296
Containers for aqueous solutions for parenteral infusion,plastic (3.2.2.1.) ........................................................................ 309
Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)....................................................................................... 291
Containers for human blood and blood components,materials based on plasticised poly(vinyl chloride) for(3.1.1.1.) ..................................................................................... 269
Containers for human blood and blood components,materials for (3.1.1.) ................................................................ 269
Containers for human blood and blood components, plastic,sterile (3.2.3.) ............................................................................ 309
Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) ...................................................................................... 289
Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ..... 279
Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.)......................................................................................... 278
Containers for pharmaceutical use, glass (3.2.1.)............... 303Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) .............................. 298
Containers of plasticised poly(vinyl chloride) for humanblood and blood components, empty sterile (3.2.4.) .........311
Containers of plasticised poly (vinyl chloride) for humanblood containing anticoagulant solution, sterile (3.2.5.).. 312
Contamination, microbial: test for specified micro-organisms(2.6.13.) .............................................................................5.6-4404
Contamination, microbial: total viable aerobic count(2.6.12.) .............................................................................5.6-4398
Content uniformity of single-dose preparations (2.9.6.).... 234
5406 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.8 Index
Control of impurities in substances for pharmaceutical use(5.10.).................................................................................5.5-4145
Control of microbiological quality, alternative methods for(5.1.6.)................................................................................5.5-4131
DDalteparin sodium ............................................................5.4-3925Dalteparinum natricum .................................................5.4-3925Danaparoid sodium ..........................................................5.5-4215Danaparoidum natricum ...............................................5.5-4215Dapsone .....................................................................................1388Dapsonum .................................................................................1388Daunorubicin hydrochloride .................................................1389Daunorubicini hydrochloridum..........................................1389D-Camphor ................................................................................. 1170D-Camphora .............................................................................. 1170Decylis oleas .............................................................................1390Decyl oleate ...............................................................................1390Deferoxamine mesilate............................................................1390Deferoxamini mesilas ............................................................1390Degree of coloration of liquids (2.2.2.).................................... 24Deliverable mass or volume of liquid and semi-solidpreparations, test for (2.9.28.)............................................... 263
Dembrexine hydrochloride monohydrate for veteri-nary use ............................................................................5.6-4563
Dembrexini hydrochloridum monohydricum ad usumveterinarium ...................................................................5.6-4563
Demeclocycline hydrochloride..............................................1392Demeclocyclini hydrochloridum ........................................1392Density of solids (2.2.42.) ........................................................... 64Density, relative (2.2.5.) .............................................................. 27Dental type silica...................................................................... 2411Depressor substances (2.6.11.)................................................ 153Deptropine citrate....................................................................1393Deptropini citras .....................................................................1393Dequalinii chloridum.............................................................1394Dequalinium chloride..............................................................1394Desipramine hydrochloride ...................................................1395Desipramini hydrochloridum ..............................................1395Deslanoside ...............................................................................1396Deslanosidum ..........................................................................1396Desmopressin.....................................................................5.8-5297Desmopressinum..............................................................5.8-5297Desogestrel .........................................................................5.5-4217Desogestrelum...................................................................5.5-4217Desoxycortone acetate............................................................1399Desoxycortoni acetas .............................................................1399Detector tubes, gas (2.1.6.) .........................................................19Determination of aflatoxin B1 in herbal drugs(2.8.18.) .............................................................................5.7-4801
Determination of essential oils in vegetable drugs(2.8.12.) .......................................................................................217
Determination of nitrogen by sulphuric acid digestion(2.5.9.) ........................................................................................ 129
Determination of primary aromatic amino-nitrogen(2.5.8.) ........................................................................................ 129
Determination of tannins in herbal drugs (2.8.14.)............ 221Determination of water by distillation (2.2.13.) .................... 32Detomidine hydrochloride for veterinary use ................... 1400Detomidini hydrochloridum ad usum veterinarium ..... 1400Devil’s claw root ....................................................................... 1401
General Notices (1) apply to all monographs and other texts 5407
Index EUROPEAN PHARMACOPOEIA 5.8
Dexamethasone ........................................................................ 1402Dexamethasone acetate.......................................................... 1403Dexamethasone isonicotinate ........................................5.4-3927Dexamethasone sodium phosphate ..................................... 1404Dexamethasoni acetas ........................................................... 1403Dexamethasoni isonicotinas .........................................5.4-3927Dexamethasoni natrii phosphas ......................................... 1404Dexamethasonum ................................................................... 1402Dexchlorpheniramine maleate .............................................. 1406Dexchlorpheniramini maleas .............................................. 1406Dexpanthenol............................................................................ 1407Dexpanthenolum..................................................................... 1407Dextran 1 for injection............................................................ 1408Dextran 40 for injection ......................................................... 1409Dextran 60 for injection ......................................................... 1410Dextran 70 for injection ..........................................................1411Dextrans, molecular mass distribution in (2.2.39.) .............. 57Dextranum 1 ad iniectabile ................................................. 1408Dextranum 40 ad iniectabile ............................................... 1409Dextranum 60 ad iniectabile ............................................... 1410Dextranum 70 ad iniectabile ................................................1411Dextrin........................................................................................ 1412Dextrinum ................................................................................. 1412Dextromethorphan hydrobromide ....................................... 1412Dextromethorphani hydrobromidum ................................ 1412Dextromoramide tartrate ........................................................1414Dextromoramidi tartras..........................................................1414Dextropropoxyphene hydrochloride.....................................1414Dextropropoxypheni hydrochloridum................................1414Diazepam ............................................................................5.6-4564Diazepamum .....................................................................5.6-4564Diazoxide ................................................................................... 1416Diazoxidum .............................................................................. 1416Dibrompropamidine diisetionate ...................................5.4-3928Dibrompropamidini diisetionas ...................................5.4-3928Dibutylis phthalas ....................................................................1417Dibutyl phthalate ......................................................................1417Dichloromethane...................................................................... 2017Diclazuril for veterinary use.................................................. 1418Diclazurilum ad usum veterinarium ................................. 1418Diclofenac potassium .............................................................. 1419Diclofenac sodium ................................................................... 1420Diclofenacum kalicum........................................................... 1419Diclofenacum natricum ........................................................ 1420Dicloxacillin sodium ................................................................ 1422Dicloxacillinum natricum..................................................... 1422Dicycloverine hydrochloride.................................................. 1423Dicycloverini hydrochloridum ............................................ 1423Didanosine..........................................................................5.2-3193Didanosinum.....................................................................5.2-3193Dienestrol .................................................................................. 1424Dienestrolum ............................................................................ 1424Diethylcarbamazine citrate .................................................... 1426Diethylcarbamazini citras .................................................... 1426Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)........................................................5.2-3095
Diphtheria and tetanus vaccine (adsorbed) ......................... 639Diphtheria and tetanus vaccine (adsorbed) for adults andadolescents.......................................................................5.6-4480
Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content).............................................................................5.6-4480
Diphtheria antitoxin .................................................................. 801Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 641
Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed)..........................................................5.4-3851
Diphtheria, tetanus and pertussis vaccine (adsorbed) ..... 643
5408 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.8 Index
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .....................5.6-4481
Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3852
Dissolution test for medicated chewing gums (2.9.25.)............................................................................................5.2-3116
Dissolution test for solid dosage forms (2.9.3.) ..........5.7-4805Dissolution test for transdermal patches (2.9.4.)................ 231Distemper vaccine (live), canine, freeze-dried...................... 740Distemper vaccine (live) for mustelids, freeze-dried........... 751Distillation range (2.2.11.).......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .............................................................................5.3-3368
Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) .......................................................5.1-2830
Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...............................................................................5.1-2827
Evening primrose oil, refined.........................................5.5-4227Extracta...............................................................................5.8-5220Extractable volume of parenteral preparations, test for(2.9.17.)..............................................................................5.3-3363
Extracta fluida ..................................................................5.8-5221Extracta sicca ....................................................................5.8-5222Extracta spissa ..................................................................5.8-5222Extracts ...............................................................................5.8-5220Extracts, dry .......................................................................5.8-5222Extracts, dry residue of (2.8.16.)............................................. 222Extracts, liquid...................................................................5.8-5221Extracts, loss on drying of (2.8.17.)........................................ 222Extracts, soft ......................................................................5.8-5222Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ...................................................................................... 169
Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.)................................5.3-3345
Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) .............................................................................5.4-3699
FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .....................................................5.1-2821
Factor humanus von Willebrandi ................................5.6-4606Factor II, human coagulation, assay of (2.7.18.) ................. 209Factor IX coagulationis humanus ...................................... 1738Factor IX, human coagulation .............................................. 1738Factor IX, human coagulation, assay of (2.7.11.) .......5.5-4120Factor VII coagulationis humanus .................................... 1734Factor VII, human coagulation............................................. 1734Factor VII, human coagulation, assay of (2.7.10.) .....5.6-4419Factor VIII coagulationis humanus............................5.6-4596Factor VIII coagulationis humanus (ADNr) .................... 1737Factor VIII, human coagulation ....................................5.6-4596Factor VIII, human coagulation, assay of (2.7.4.) ......5.5-4119Factor VIII (rDNA), human coagulation ............................. 1737Factor X, human coagulation, assay of (2.7.19.) ..................210Factor XI coagulationis humanus ...............................5.5-4246Factor XI, human coagulation .......................................5.5-4246Factor XI, human coagulation, assay of (2.7.22.).......5.5-4121
Fagopyri herba .................................................................5.8-5278Falling ball viscometer method (2.2.49.) ................................ 80Famotidine.................................................................................1575Famotidinum............................................................................1575Fatty acids, composition by gas chromatography(2.4.22.) .............................................................................5.6-4389
Fatty oils, alkaline impurities in (2.4.19.) ............................. 109Fatty oils and herbal drugs, heavy metals in (2.4.27.) ........119Fatty oils and resinified essential oils in essential oils(2.8.7.)..........................................................................................216
Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) ...................................................................................... 109
Fatty oils, identification by thin-layer chromatography(2.3.2.) .......................................................................................... 98
Fatty oils, sterols in (2.4.23.) ..........................................5.1-2787Fatty oils, vegetable..........................................................5.8-5233Fc function of immunoglobulin, test for (2.7.9.) ................. 202Febantel for veterinary use.............................................5.8-5315Febantelum ad usum veterinarium.............................5.8-5315Feline calicivirosis vaccine (inactivated) ............................... 757Feline calicivirosis vaccine (live), freeze-dried ..................... 758Feline chlamydiosis vaccine (inactivated)....................5.6-4489Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .............................................................................. 759
General Notices (1) apply to all monographs and other texts 5411
Index EUROPEAN PHARMACOPOEIA 5.8
Fila non resorbilia sterilia .............................................5.3-3423Fila non resorbilia sterilia in fuso ad usumveterinarium ............................................................................ 888
Filum ethyleni polyterephthalici sterile in fuso ad usumveterinarium ............................................................................ 887
Filum lini sterile in fuso ad usum veterinarium .............. 886Filum polyamidicum-6/6 sterile in fuso ad usumveterinarium ............................................................................ 887
Filum polyamidicum-6 sterile in fuso ad usumveterinarium ............................................................................ 886
Finasteride.................................................................................1594Finasteridum ............................................................................1594Fish oil, rich in omega-3-acids........................................5.4-3941Flecainide acetate ....................................................................1598Flecainidi acetas .....................................................................1598Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.) ...................................5.6-4424
HHaematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.).........................................................................5.6-4421
Haematopoietic stem cells, human ...............................5.6-4598
General Notices (1) apply to all monographs and other texts 5413
Index EUROPEAN PHARMACOPOEIA 5.8
Haemodiafiltration and for haemofiltration, solutionsfor .............................................................................................. 1703
Haemodialysis, concentrated solutions for ........................ 1700Haemodialysis solutions, concentrated, water fordiluting..................................................................................... 1699
Haemodialysis, solutions for.................................................. 1700Haemofiltration and for haemodiafiltration, solutionsfor .............................................................................................. 1703
Haemophilus type b (conjugate), diphtheria, tetanusand pertussis (acellular, component) vaccine(adsorbed).........................................................................5.4-3852
Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component) and poliomyelitis(inactivated) vaccine (adsorbed) ..................................5.4-3861
Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component), hepatitis B (rDNA) andpoliomyelitis (inactivated) vaccine (adsorbed) .........5.4-3858
Haemophilus type b (conjugate), diphtheria, tetanus,pertussis and poliomyelitis (inactivated) vaccine(adsorbed).........................................................................5.4-3866
Haemophilus type b conjugate vaccine................................. 662Halofantrine hydrochloride ................................................... 1705Halofantrini hydrochloridum .............................................. 1705Haloperidol................................................................................ 1706Haloperidol decanoate............................................................ 1708Haloperidoli decanoas........................................................... 1708Haloperidolum ......................................................................... 1706Halothane .................................................................................. 1709Halothanum.............................................................................. 1709Hamamelidis folium ............................................................... 1711Hamamelis leaf ......................................................................... 1711Hard capsules.....................................................................5.5-4155Hard fat ...................................................................................... 1711Hard paraffin............................................................................. 2186Harpagophyti radix ................................................................ 1401Hawthorn berries ..................................................................... 1712Hawthorn leaf and flower ...................................................... 1713Hawthorn leaf and flower dry extract ................................. 1714Hawthorn leaf and flower liquid extract, quantified ..5.3-3511Heavy bismuth subnitrate ...................................................... 1107Heavy kaolin..............................................................................1869Heavy magnesium carbonate .........................................5.3-3547Heavy magnesium oxide..................................................5.6-4629Heavy metals (2.4.8.) ................................................................. 104Heavy metals in herbal drugs and fatty oils (2.4.27.)..........119Hederae folium .................................................................5.6-4613Hedera helix ad praeparationes homoeopathicas...5.2-3163Hedera helix for homoeopathic preparations.............5.2-3163Helianthi annui oleum raffinatum..................................... 2524Helium .................................................................................5.7-5023Helium ................................................................................ 5.7-502 3Heparina massae molecularis minoris ..............................1717Heparin, assay of (2.7.5.) .................................................5.6-4419Heparin calcium ................................................................5.5-4245Heparin in coagulation factors, assay of (2.7.12.)............... 204Heparins, low-molecular-mass ................................................1717Heparin sodium.................................................................5.5-4245Heparinum calcicum ......................................................5.5-4245Heparinum natricum ......................................................5.5-4245Hepatitis A immunoglobulin, human ...................................1741Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 664
Hepatitis A vaccine, assay of (2.7.14.) ...........................5.1-2795Hepatitis A vaccine (inactivated, adsorbed) ......................... 665Hepatitis A vaccine (inactivated, virosome) ......................... 667Hepatitis B immunoglobulin for intravenous administration,human .......................................................................................1741
Hepatitis B immunoglobulin, human ...................................1741
Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed).................................................................................. 641
Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ...............5.4-3854
Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ..........................5.4-3858
Hepatitis B vaccine (rDNA)...................................................... 670Hepatitis B vaccine (rDNA), assay of (2.7.15.) ..................... 207Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : Guidelines..............................................5.5-4113
Heptaminol hydrochloride ..................................................... 1719Heptaminoli hydrochloridum .............................................. 1719Herbal drug preparations......................................................... 572Herbal drugs ............................................................................... 572Herbal drugs and fatty oils, heavy metals in (2.4.27.).........119Herbal drugs, determination of aflatoxin B1 in(2.8.18.) .............................................................................5.7-4801
Homoeopathic preparations, copper for............................... 896Homoeopathic preparations, garlic for ................................. 897Homoeopathic preparations, hedera helix for............5.2-3163Homoeopathic preparations, herbal drugs for ........... 5.2-3161Homoeopathic preparations, honey bee for......................... 898Homoeopathic preparations, hyoscyamus for ............5.2-3164Homoeopathic preparations, hypericum for ........................ 898Homoeopathic preparations, iron for .................................... 899Homoeopathic preparations, mother tinctures for............. 894Homoeopathic preparations, oriental cashew for......5.3-3430Homoeopathic preparations, saffron for............................... 900Homoeopathic stocks (methods of preparation of) andpotentisation....................................................................5.8-5260
Honey ..................................................................................5.1-2946Honey bee for homoeopathic preparations.......................... 898
5414 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.8 Index
Hop strobile............................................................................... 1730Human albumin injection, iodinated (125I)............................ 827Human albumin solution ................................................5.3-3511Human anti-D immunoglobulin .....................................5.6-4595Human anti-D immunoglobulin, assay of (2.7.13.).............. 205Human anti-D immunoglobulin for intravenousadministration .................................................................5.6-4595
Human antithrombin III, assay of (2.7.17.) ........................... 209Human antithrombin III concentrate .................................. 1733Human coagulation factor II, assay of (2.7.18.)................... 209Human coagulation factor IX................................................ 1738Human coagulation factor IX, assay of (2.7.11.).........5.5-4120Human coagulation factor VII .............................................. 1734Human coagulation factor VII, assay of (2.7.10.) .......5.6-4419Human coagulation factor VIII......................................5.6-4596Human coagulation factor VIII, assay of (2.7.4.)........5.5-4119Human coagulation factor VIII (rDNA)............................... 1737Human coagulation factor X, assay of (2.7.19.) ....................210Human coagulation factor XI.........................................5.5-4246Human coagulation factor XI, assay of (2.7.22.) ........5.5-4121Human fibrinogen.............................................................5.6-4597Human haematopoietic stem cells ................................5.6-4598Human hepatitis A immunoglobulin ....................................1741Human hepatitis B immunoglobulin ....................................1741Human hepatitis B immunoglobulin for intravenousadministration .........................................................................1741
Human insulin ..........................................................................1800Human measles immunoglobulin......................................... 1742Human normal immunoglobulin...................................5.6-4599Human normal immunoglobulin for intravenousadministration .................................................................5.6-4601
Human plasma for fractionation....................................5.6-4603Human plasma (pooled and treated for virusinactivation) .....................................................................5.6-4604
IIbuprofen ................................................................................... 1785Ibuprofenum............................................................................. 1785Iceland moss.......................................................................5.3-3525ICH (5.8.)...................................................................................... 551Ichthammol ............................................................................... 1787Ichthammolum ........................................................................ 1787Identification (2.3.) ...................................................................... 95Identification and control of residual solvents (2.4.24.).... 113Identification of fatty oils by thin-layer chromatography(2.3.2.) .......................................................................................... 98
Identification of phenothiazines by thin-layerchromatography (2.3.3.) ........................................................... 99
Identification reactions of ions and functional groups(2.3.1.)................................................................................ 5.5-4101
General Notices (1) apply to all monographs and other texts 5415
Index EUROPEAN PHARMACOPOEIA 5.8
Iecoris aselli oleum B ............................................................1352Ifosfamide .................................................................................. 1789Ifosfamidum ............................................................................. 1789Imipenem ................................................................................... 1791Imipenemum ............................................................................ 1791Imipramine hydrochloride ..................................................... 1792Imipramini hydrochloridum................................................ 1792Immunochemical methods (2.7.1.) ......................................... 187Immunoglobulin for human use, anti-T lymphocyte,animal................................................................................5.6-4506
Immunoglobulin for intravenous administration, humanhepatitis B ................................................................................1741
Immunoglobulin for intravenous administration, humannormal ...............................................................................5.6-4601
Immunoglobulin for intravenous administration, humanvaricella.................................................................................... 1753
Immunoglobulin, human anti-D ....................................5.6-4595Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 205Immunoglobulin, human anti-D, for intravenousadministration .................................................................5.6-4595
Immunoglobulin, human hepatitis A....................................1741Immunoglobulin, human hepatitis B ...................................1741Immunoglobulin, human measles ........................................ 1742Immunoglobulin, human normal ..................................5.6-4599Immunoglobulin, human rabies ........................................... 1750Immunoglobulin, human rubella ......................................... 1751Immunoglobulin, human tetanus......................................... 1751Immunoglobulin, human varicella ....................................... 1752Immunoglobulin, test for anticomplementary activity of(2.6.17.)....................................................................................... 170
Immunoglobulin, test for Fc function of (2.7.9.)................. 202Immunoglobulinum anti-T lymphocytorum ex animale adusum humanum .............................................................5.6-4506
Immunoglobulinum humanum anti-D.......................5.6-4595Immunoglobulinum humanum anti-D ad usumintravenosum ..................................................................5.6-4595
Immunoglobulinum humanum hepatitidis A ..................1741Immunoglobulinum humanum hepatitidis B ..................1741Immunoglobulinum humanum hepatitidis B ad usumintravenosum ..........................................................................1741
Immunosera ad usum veterinarium ...........................5.4-3835Immunosera and vaccines, phenol in (2.5.15.) .....................131Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...............................................................................5.1-2827
Immunosera and vaccines, veterinary, evaluation of theefficacy (5.2.7) .................................................................5.1-2829
Immunosera and vaccines, veterinary, evaluation of thesafety of each batch (5.2.9.) ..........................................5.1-2830
Immunosera ex animale ad usum humanum ..........5.8-5222Immunosera for human use, animal.............................5.8-5222Immunosera for veterinary use......................................5.4-3835Immunoserum botulinicum ................................................... 801Immunoserum clostridii novyi alpha ad usumveterinarium ...................................................................5.1-2865
Immunoserum clostridii perfringentis beta ad usumveterinarium ...................................................................5.1-2866
Immunoserum clostridii perfringentis epsilon ad usumveterinarium ...................................................................5.1-2867
Immunoserum contra venena viperarumeuropaearum ........................................................................... 806
Immunoserum gangraenicum (Clostridium septicum) .. 804Immunoserum gangraenicum mixtum ............................... 802Immunoserum tetanicum ad usum humanum................. 805Immunoserum tetanicum ad usum veterinarium...5.1-2868Implants ..............................................................................5.2-3146Impurities in substances for pharmaceutical use, control of(5.10.).................................................................................5.5-4145
Indapamide.........................................................................5.3-3525Indapamidum ...................................................................5.3-3525Indian frankincense..........................................................5.7-5031Indicators, relationship between approximate pH and colour(2.2.4.) .......................................................................................... 27
Iobenguane (123I) injection..............................................5.7-4957Iobenguane (131I) injection for diagnostic use ............5.7-4958Iobenguane (131I) injection for therapeutic use ..........5.7-4959Iobenguane sulphate for radiopharmaceuticalpreparations .....................................................................5.8-5255
Liquid and semi-solid preparations, test for deliverable massor volume (2.9.28.) .................................................................. 263
5418 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.8 Index
Liquid maltitol ...................................................................5.5-4271Liquid paraffin .......................................................................... 2187Liquid preparations for cutaneous application ..........5.5-4159Liquid preparations for cutaneous application,veterinary .................................................................................. 630
Liquid preparations for inhalation ................................5.1-2843Liquid preparations for oral use....................................5.6-4471Liquids, clarity and degree of opalescence of(2.2.1.)................................................................................5.7-4777
Mass uniformity of single-dose preparations (2.9.5.) ......... 233Mastic..........................................................................................1975Masticabilia gummis medicata.....................................5.2-3136Mastix .........................................................................................1975Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 291
Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) ...................................................................................... 289
Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 296
Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 269
Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 272
Materials for containers for human blood and bloodcomponents (3.1.1.) ................................................................. 269
Materials used for the manufacture of containers (3.1.) ... 269Matricariae aetheroleum................................................5.1-2967Matricariae extractum fluidum ....................................5.1-2966Matricariae flos ................................................................5.1-2965Matricaria flower ...............................................................5.1-2965Matricaria liquid extract ..................................................5.1-2966Matricaria oil ......................................................................5.1-2967Maydis amylum ................................................................5.1-2965Maydis oleum raffinatum......................................................1964Meadowsweet ............................................................................1980Measles immunoglobulin, human ........................................ 1742Measles, mumps and rubella vaccine (live) .......................... 678Measles vaccine (live) ................................................................ 679Measurement of consistency by penetrometry (2.9.9.) ...... 235Mebendazole ............................................................................. 1981Mebendazolum......................................................................... 1981Meclozine hydrochloride ........................................................1982Meclozini hydrochloridum ...................................................1982Medicated chewing gum, dissolution test for(2.9.25.) .............................................................................5.2-3116
Microbiological assay of antibiotics (2.7.2.).......................... 188Microbiological control of cellular products(2.6.27.) .............................................................................5.6-4414
Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ............................5.6-4404
Microbiological quality, alternative methods for control of(5.1.6.)................................................................................5.5-4131
Microbiological quality of pharmaceutical preparations(5.1.4.)................................................................................5.6-4451
Microcrystalline cellulose................................................5.7-4985Micro determination of water (2.5.32.).................................. 137Microscopy, optical (2.9.37.) ...........................................5.3-3366Midazolam ..........................................................................5.4-3979Midazolamum ...................................................................5.4-3979Milk thistle dry extract, refined and standardised.....5.6-4635Milk-thistle fruit.................................................................5.7-5055Millefolii herba..................................................................5.7-5145Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 463
Minocycline hydrochloride dihydrate ...........................5.7-5056Minocyclini hydrochloridum dihydricum .................5.7-5056Minoxidil .............................................................................5.1-2974Minoxidilum ......................................................................5.1-2974Mint oil, partly dementholised .......................................5.2-3235Mirtazapine ........................................................................5.8-5334Mirtazapinum ...................................................................5.8-5334Misoprostol.........................................................................5.3-3553Misoprostolum ..................................................................5.3-3553Mitomycin .................................................................................. 2051Mitomycinum ........................................................................... 2051Mitoxantrone hydrochloride...........................................5.6-4637Mitoxantroni hydrochloridum ......................................5.6-4637Modafinil .............................................................................5.6-4638Modafinilum ......................................................................5.6-4638Modified-release capsules................................................5.5-4156Modified-release granules ............................................... 5.2-3141Modified-release tablets ...................................................5.8-5240Molecular mass distribution in dextrans (2.2.39.) ................ 57Molgramostim concentrated solution .................................2054Molgramostimi solutio concentrata ...................................2054Mometasone furoate.........................................................5.7-5058Mometasoni furoas ..........................................................5.7-5058Monoclonal antibodies for human use.........................5.8-5224Morantel hydrogen tartrate for veterinary use ..........5.7-5059Moranteli hydrogenotartras ad usum veterinarium ........5.7-5059
Morphine hydrochloride..................................................5.2-3237Morphine sulphate............................................................5.2-3238Morphini hydrochloridum .............................................5.2-3237Morphini sulfas.................................................................5.2-3238Moss, Iceland .....................................................................5.3-3525Mother tinctures for homoeopathic preparations .............. 894Motherwort ...............................................................................2063Mouthwashes .....................................................................5.4-3845Moxifloxacin hydrochloride ............................................5.8-5335Moxifloxacini hydrochloridum ....................................5.8-5335Moxonidine ................................................................................2064Moxonidinum ...........................................................................2064Mucoadhesive preparations ............................................5.4-3847Mullein flower...........................................................................2065Multidose containers, uniformity of mass of delivered doses(2.9.27.) ...................................................................................... 263
General Notices (1) apply to all monographs and other texts 5421
Omega-3-acids, fish oil rich in ........................................5.4-3941Omega-3 acids, total cholesterol in oils rich in(2.4.32.) .............................................................................5.8-5197
Parenteralia .......................................................................5.2-3144Parenteral preparations...................................................5.2-3144Parenteral preparations, test for extractable volume of(2.9.17.)..............................................................................5.3-3363
5424 See the information section on general monographs (cover pages)
Particle size analysis by laser light diffraction(2.9.31.) .............................................................................5.6-4429
Particle-size distribution estimation by analytical sieving(2.9.38.) .............................................................................5.3-3368
Plasma (pooled and treated for virus inactivation),human ...............................................................................5.6-4604
Plasmid vectors for human use......................................5.6-4466Plasmid vectors for human use, bacterial cells used for themanufacture of ................................................................5.6-4468
Plasters, medicated...........................................................5.5-4164Plastic additives (3.1.13.).......................................................... 293Plastic containers and closures for pharmaceutical use(3.2.2.) ........................................................................................ 308
Plastic containers for aqueous solutions for parenteralinfusion (3.2.2.1.) ..................................................................... 309
Plastic containers for human blood and blood components,sterile (3.2.3.) ............................................................................ 309
Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)..........................................................5.4-3864
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)..........................................................5.4-3861
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ..........................5.4-3858
Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3866
Poliomyelitis vaccine (inactivated) ................................5.4-3868Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .............................................................................5.6-4420
Poliomyelitis vaccine (oral) .............................................5.3-3410Poliomyelitis vaccine (oral), test for neurovirulence(2.6.19.) ...................................................................................... 172
Poloxamera ........................................................................5.8-5352Poloxamers .........................................................................5.8-5352Polyacrylate dispersion 30 per cent.....................................2265Polyacrylatis dispersio 30 per centum ..............................2265Poly(alcohol vinylicus) ..........................................................2272Polyamide 6/6 suture, sterile, in distributor for veterinaryuse .............................................................................................. 887
Polyamide 6 suture, sterile, in distributor for veterinary use..................................................................................................... 886
5426 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.8 Index
Polyethylene terephthalate for containers for preparationsnot for parenteral use (3.1.15.) ............................................. 298
Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use .......................................................................... 887
Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.) ................. 285
Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ... 279
Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ... 278
Polygalae radix ........................................................................ 2401Polygoni avicularis herba .....................................................1877Polymorphism (5.9.) .................................................................. 555Polymyxin B sulphate ......................................................5.7-5094Polymyxini B sulfas.........................................................5.7-5094Polyolefines (3.1.3.) ................................................................... 274Polyoxyl castor oil.............................................................5.3-3547Polyoxyl hydrogenated castor oil ..................................5.2-3231Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.).......... 282
Polysaccharide vaccines, hexosamines in (2.5.20.)............. 132Polysaccharide vaccines, methylpentoses in (2.5.21.)........ 133Polysaccharide vaccines, nucleic acids in (2.5.17.) ............. 132Polysaccharide vaccines, O-acetyl in (2.5.19.)...................... 132Polysaccharide vaccines, phosphorus in (2.5.18.)............... 132Polysaccharide vaccines, protein in (2.5.16.) ........................131Polysaccharide vaccines, ribose in (2.5.31.) ......................... 137Polysaccharide vaccines, sialic acid in (2.5.23.) .................. 133Polysaccharide vaccines, uronic acids in (2.5.22.) .............. 133Polysorbate 20 ..........................................................................2267Polysorbate 40 ..........................................................................2268Polysorbate 60 ..........................................................................2269Polysorbate 80 ...................................................................5.4-4007Polysorbatum 20 .....................................................................2267Polysorbatum 40 .....................................................................2268Polysorbatum 60 .....................................................................2269Polysorbatum 80 ..............................................................5.4-4007Poly(vinyl acetate)....................................................................2271Poly(vinyl acetate) dispersion 30 per cent ..................5.8-5353Poly(vinyl alcohol) ...................................................................2272Poly(vinyl chloride), non-plasticised, materials based on forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 291
Poly(vinyl chloride), non-plasticised, materials based onfor containers for non-injectable aqueous solutions(3.1.10.) ...................................................................................... 289
Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) ..............311
Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 296
Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 269
Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 272
Potentiometric determination of pH (2.2.3.).......................... 26Potentiometric titration (2.2.20.).............................................. 35Potentisation, methods of preparation of homoeopathicstocks and.........................................................................5.8-5260
Powders and granules for syrups ..................................5.6-4472Powders and tablets for rectal solutions andsuspensions......................................................................5.5-4163
Powders, ear.......................................................................5.5-4157Powders, effervescent.......................................................5.2-3148Powders for cutaneous application...............................5.2-3147Powders for eye drops and powders for eye lotions ..5.5-4159Powders for inhalation.....................................................5.1-2845Powders for injections or infusions ..............................5.2-3145Powders for oral drops.....................................................5.6-4472Powders, nasal ...................................................................5.6-4474Powders, oral .....................................................................5.2-3147Poxvirus vectors for human use ....................................5.6-4464Praeadmixta ad alimenta medicataad usum veterinarium ............................................................617
Praeparationes ad irrigationem...................................5.6-4474Praeparationes buccales ................................................5.4-3844Praeparationes homoeopathicas .................................5.8-5259Praeparationes insulini iniectabiles ...........................5.4-3957Praeparationes intramammariaead usum veterinarium ........................................................... 606
Praeparationes intraruminales .................................... 5.2-3141Praeparationes intra-uterinae ad usum veterinarium ....5.3-3397
Praeparationes liquidae ad usum dermicum ...........5.5-4159Praeparationes liquidae peroraliae.............................5.6-4471Praeparationes liquidae veterinariae ad usum dermicum..................................................................................................... 630
Praeparationes molles ad usum dermicum ..............5.5-4164Praeparationes pharmaceuticae in vasis cum pressu..... 622
General Notices (1) apply to all monographs and other texts 5427
Index EUROPEAN PHARMACOPOEIA 5.8
Pravastatin sodium...........................................................5.8-5355Pravastatinum natricum ................................................5.8-5355Prazepam ...................................................................................2293Prazepamum ............................................................................2293Praziquantel ..............................................................................2294Praziquantelum .......................................................................2294Prazosin hydrochloride ..........................................................2295Prazosini hydrochloridum ...................................................2295Prednicarbate............................................................................2297Prednicarbatum.......................................................................2297Prednisolone .............................................................................2298Prednisolone acetate........................................................5.6-4664Prednisolone pivalate.............................................................. 2301Prednisolone sodium phosphate ..........................................2302Prednisoloni acetas .........................................................5.6-4664Prednisoloni natrii phosphas ..............................................2302Prednisoloni pivalas............................................................... 2301Prednisolonum ........................................................................2298Prednisone.................................................................................2303Prednisonum ............................................................................2303Prekallikrein activator (2.6.15.) .....................................5.5-4111Premixes for medicated feeding stuffs for veterinary use ..617Preparations for inhalation.............................................5.1-2843Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) ............................................................5.2-3103
Products of fermentation ......................................................... 576Products of recombinant DNA technology .................5.8-5227Products with risk of transmitting agents of animalspongiform encephalopathies............................................... 577
QQuality of pharmaceutical preparations, microbiological(5.1.4.)................................................................................5.6-4451
RRabies immunoglobulin, human .......................................... 1750Rabies vaccine for human use prepared in cellcultures .............................................................................5.8-5245
Recombinant DNA technology, products of................5.8-5227Rectal capsules ..................................................................5.5-4163Rectal foams.......................................................................5.5-4164Rectalia ...............................................................................5.5-4162Rectal preparations...........................................................5.5-4162Rectal preparations, semi-solid ......................................5.5-4164Rectal solutions and suspensions, powders and tabletsfor .......................................................................................5.5-4162
Rectal solutions, emulsions and suspensions.............5.5-4163Rectal tampons..................................................................5.5-4164Red poppy petals......................................................................2359Reference standards (5.12.) ............................................5.6-4455Refractive index (2.2.6.) .............................................................. 28Relationship between reaction of solution, approximate pHand colour of certain indicators (2.2.4.) ............................... 27
Relative density (2.2.5.)............................................................... 27Repaglinide.........................................................................5.2-3267Repaglinidum....................................................................5.2-3267Reserpine ...................................................................................2360Reserpinum ..............................................................................2360Residual solvents (5.4.) ............................................................. 507Residual solvents, identification and control (2.4.24.) ...... 113Residue on evaporation of essential oils (2.8.9.)..................216Resistance to crushing of tablets (2.9.8.) ............................. 235
Resistance to rupture of suppositories and pessaries(2.9.24.) ...................................................................................... 258
Semi-micro determination of water (2.5.12.) ..............5.7-4785Semi-solid and liquid preparations, test for deliverable massor volume (2.9.28.) .................................................................. 263
Serum bovinum ................................................................5.4-3903Sesame oil, refined ...........................................................5.8-5361Sesami oleum raffinatum ..............................................5.8-5361Sets for the transfusion of blood and blood components(3.2.6.) .........................................................................................313
Shampoos ...........................................................................5.5-4160Shellac .......................................................................................2409Sialic acid in polysaccharide vaccines (2.5.23.)................... 133Siam benzoin .....................................................................5.2-3175Siam benzoin tincture......................................................5.4-3902Sieves (2.1.4.) .................................................................................18Sieve test (2.9.12.)...................................................................... 239Sieving, analytical, particle-size distribution estimation by(2.9.38.) .............................................................................5.3-3368
SI (International System) units (1.) ..............................5.6-4373Silica ad usum dentalem....................................................... 2411Silica, colloidal anhydrous ..................................................... 2410Silica, colloidal hydrated ........................................................ 2411Silica colloidalis anhydrica.................................................. 2410Silica colloidalis hydrica....................................................... 2411Silica, dental type..................................................................... 2411Silica hydrophobica colloidalis anhydrica ...............5.8-5362Silica, hydrophobic colloidal anhydrous......................5.8-5362Silicone elastomer for closures and tubing (3.1.9.) ............ 288Silicone oil used as a lubricant (3.1.8.) ................................. 287Silk suture, sterile, braided, in distributor for veterinary use..................................................................................................... 887
Silver, colloidal, for external use ...................................5.3-3613Silver nitrate ............................................................................. 2412Silybi mariani extractum siccum raffinatum etnormatum ........................................................................5.6-4635
Soft extracts .......................................................................5.8-5222Soiae oleum hydrogenatum .................................................2475Soiae oleum raffinatum ........................................................ 2476Solani amylum ........................................................................2288Solidaginis herba .............................................................5.2-3213Solidaginis virgaureae herba........................................5.3-3507Solid dosage forms, dissolution test for (2.9.3.) .........5.7-4805Solids, density of (2.2.42.) .......................................................... 64Solids, pycnometric density of (2.9.23.) ................................ 257Solubility in alcohol of essential oils (2.8.10.) ......................216Soluble tablets ...................................................................5.8-5240Solutiones ad conservationem partium corporis ...........2458Solutiones ad haemocolaturamhaemodiacolaturamque ...................................................... 1703
Solutiones ad haemodialysim ............................................. 1700Solutiones ad peritonealem dialysim ................................ 2212Solutiones anticoagulantes et sanguinem humanumconservantes .......................................................................... 1007
Solutions, emulsions and suspensions, oral ...............5.6-4471Solutions for haemodialysis................................................... 1700Solutions for haemodialysis, concentrated, water fordiluting..................................................................................... 1699
Solutions for haemofiltration and for haemodiafiltra-tion............................................................................................ 1703
Solutions for organ preservation..........................................2458Solutions for peritoneal dialysis ........................................... 2212Solutions, suspensions, intrauterine ............................5.3-3397Solvents, residual (5.4.) ............................................................ 507Solvents, residual, identification and control (2.4.24.) ...... 113Somatostatin ......................................................................5.8-5364Somatostatinum ...............................................................5.8-5364Somatropin.........................................................................5.8-5365Somatropin concentrated solution ...............................5.8-5367Somatropin for injection .................................................5.8-5369Somatropini solutio concentrata .................................5.8-5367Somatropinum ..................................................................5.8-5365Somatropinum ad iniectabilium..................................5.8-5369Sorbic acid.................................................................................2467Sorbitani lauras .......................................................................2467Sorbitani oleas .........................................................................2468Sorbitani palmitas ..................................................................2468Sorbitani sesquioleas .............................................................2468Sorbitani stearas .....................................................................2469Sorbitani trioleas ....................................................................2469Sorbitan laurate .......................................................................2467Sorbitan oleate .........................................................................2468Sorbitan palmitate ...................................................................2468Sorbitan sesquioleate..............................................................2468Sorbitan stearate......................................................................2469Sorbitan trioleate .....................................................................2469Sorbitol.......................................................................................2470Sorbitol, liquid (crystallising)................................................2471Sorbitol, liquid (non-crystallising)........................................2472Sorbitol, liquid, partially dehydrated...................................2473Sorbitolum ................................................................................2470Sorbitolum liquidum cristallisabile....................................2471Sorbitolum liquidum non cristallisabile ...........................2472Sorbitolum liquidum partim deshydricum ......................2473Sotalol hydrochloride ............................................................. 2474Sotaloli hydrochloridum ....................................................... 2474Soya-bean oil, hydrogenated..................................................2475Soya-bean oil, refined.............................................................. 2476Specific surface area by air permeability (2.9.14.).............. 239Specific surface area by gas adsorption (2.9.26.) ......5.1-2811Spectinomycin dihydrochloride pentahydrate ...........5.7-5109Spectinomycin hydrochloride.........................................5.4-4020Spectinomycini dihydrochloridum pentahydricum ........5.7-5109
Spectinomycini sulfas tetrahydricus ad usumveterinarium ................................................................... 5.7-5111
Spectinomycin sulphate tetrahydrate for veterinary use ..5.7-5111
Stearic acid.........................................................................5.6-4681Stearoyl macrogolglycerides ..........................................5.2-3274Stearyl alcohol...................................................................5.3-3621Stem cells, human haematopoietic ...............................5.6-4598Sterile braided silk suture in distributor for veterinaryuse............................................................................................... 887
Sterile catgut............................................................................... 873Sterile catgut in distributor for veterinary use ................... 885Sterile containers of plasticised poly (vinyl chloride)for human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 312
Sterile linen thread in distributor for veterinary use......... 886Sterile non-absorbable strands in distributor for veterinaryuse............................................................................................... 888
Sterile non-absorbable sutures ......................................5.3-3423Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ................................................................. 309
Sterile polyamide 6/6 suture in distributor for veterinaryuse............................................................................................... 887
Sterile polyamide 6 suture in distributor for veterinaryuse............................................................................................... 886
Sterile poly(ethylene terephthalate) suture in distributor forveterinary use ........................................................................... 887
Sublingual tablets and buccal tablets ..........................5.4-3847Substances for pharmaceutical use ..............................5.8-5229Substances for pharmaceutical use, control of impurities in(5.10.).................................................................................5.5-4145
Substances of animal origin for the production of veterinaryvaccines (5.2.5.) ........................................................................ 460
Sub-visible particles, particulate contamination (2.9.19.) .. 253Succinylsulfathiazole ..............................................................2498Succinylsulfathiazolum .........................................................2498Sucrose................................................................................5.5-4299Sufentanil .................................................................................. 2501Sufentanil citrate .....................................................................2502Sufentanili citras .....................................................................2502Sufentanilum............................................................................ 2501Sugars, lead in (2.4.10.) ............................................................ 107Sugar spheres ...........................................................................2503Sulbactam sodium ............................................................5.8-5372Sulbactamum natricum..................................................5.8-5372Sulfacetamide sodium.............................................................2504Sulfacetamidum natricum ....................................................2504Sulfadiazine...............................................................................2505Sulfadiazinum .........................................................................2505Sulfadimidine............................................................................2506Sulfadimidinum.......................................................................2506Sulfadoxine................................................................................2507Sulfadoxinum...........................................................................2507Sulfafurazole.............................................................................2508Sulfafurazolum ........................................................................2508Sulfaguanidine...................................................................5.5-4302Sulfaguanidinum .............................................................5.5-4302Sulfamerazine ...........................................................................2509Sulfamerazinum......................................................................2509Sulfamethizole.......................................................................... 2510Sulfamethizolum ..................................................................... 2510Sulfamethoxazole .............................................................5.3-3623Sulfamethoxazolum.........................................................5.3-3623Sulfamethoxypyridazine for veterinary use ....................... 2512Sulfamethoxypyridazinum ad usum veterinarium ....... 2512Sulfanilamide ............................................................................ 2513Sulfanilamidum....................................................................... 2513Sulfasalazine ............................................................................. 2514Sulfasalazinum ........................................................................ 2514Sulfathiazole ............................................................................. 2516Sulfathiazolum ........................................................................ 2516Sulfinpyrazone ......................................................................... 2517Sulfinpyrazonum .................................................................... 2517Sulfisomidine ............................................................................ 2518Sulfisomidinum ....................................................................... 2518Sulfur ad usum externum .....................................................2520Sulfuris colloidalis et technetii (99mTc) solutioiniectabilis ................................................................................ 852
Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ..........................5.3-3348
Test for deliverable mass or volume of liquid and semi-solidpreparations (2.9.28.).............................................................. 263
Test for extractable volume of parenteral preparations(2.9.17.)..............................................................................5.3-3363
General Notices (1) apply to all monographs and other texts 5433
Index EUROPEAN PHARMACOPOEIA 5.8
Test for Fc function of immunoglobulin (2.7.9.) ................. 202Test for methanol and 2-propanol (2.9.11.) .................5.3-3362Test for neurovirulence of live virus vaccines (2.6.18.) ..... 172Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 172
Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) .........5.6-4404
Testosterone..............................................................................2542Testosterone decanoate ...................................................5.8-5379Testosterone enantate.............................................................2544Testosterone isocaproate.................................................5.8-5380Testosterone propionate.........................................................2545Testosteroni decanoas.....................................................5.8-5379Testosteroni enantas ..............................................................2544Testosteroni isocaproas ..................................................5.8-5380Testosteroni propionas ..........................................................2545Testosteronum..........................................................................2542Tests for extraneous agents in viral vaccines for human use(2.6.16.) ...................................................................................... 169
Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ....................................5.6-4424
Tetanus and diphtheria vaccine (adsorbed, reducedantigen(s) content) .........................................................5.6-4480
Tetanus antitoxin for human use ........................................... 805Tetanus antitoxin for veterinary use.............................5.1-2868Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 641
Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed)..........................................................5.4-3851
Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .....................5.6-4481
Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3852
Total organic carbon in water for pharmaceutical use(2.2.44.) ........................................................................................ 68
Total protein (2.5.33.) ............................................................... 138Total viable aerobic count (microbiological examination ofnon-sterile products) (2.6.12.) ......................................5.6-4398
Toxicity, abnormal (2.6.9.)........................................................ 153Toxin, botulinum type A for injection...................................1117Toxinum botulinicum typum A ad iniectabile .................1117Tragacanth ................................................................................2606Tragacantha..............................................................................2606Tramadol hydrochloride .........................................................2607Tramadoli hydrochloridum ..................................................2607Tramazoline hydrochloride monohydrate ...................5.3-3633Tramazolini hydrochloridum monohydricum .........5.3-3633Trandolapril........................................................................5.4-4034Trandolaprilum ................................................................5.4-4034Tranexamic acid ................................................................5.8-5382Transdermal patches ........................................................5.2-3146Transdermal patches, dissolution test for (2.9.4.) .............. 231Trapidil ....................................................................................... 2610Trapidilum ................................................................................ 2610Tretinoin .................................................................................... 2611Tretinoinum.............................................................................. 2611Triacetin ..................................................................................... 2612Triacetinum .............................................................................. 2612Triamcinolone........................................................................... 2613Triamcinolone acetonide........................................................ 2614Triamcinolone hexacetonide ................................................. 2616Triamcinoloni acetonidum................................................... 2614Triamcinoloni hexacetonidum ............................................ 2616Triamcinolonum ..................................................................... 2613Triamterene ............................................................................... 2617Triamterenum .......................................................................... 2617
TSE, animal, products with risk of transmitting agentsof.................................................................................................. 577
Tuberculin for human use, old..............................................2638Tuberculini aviarii derivatum proteinosumpurificatum......................................................................5.7-5129
Tuberculini derivatum proteinosum purificatum ad usumhumanum ...............................................................................2642
Tuberculin purified protein derivative, avian .............5.7-5129Tuberculin purified protein derivative, bovine...........5.7-5130Tuberculin purified protein derivative for human use ....2642Tuberculinum pristinum ad usum humanum ................2638Tubes for comparative tests (2.1.5.) ..........................................19Tubing and closures, silicone elastomer for (3.1.9.)........... 288
General Notices (1) apply to all monographs and other texts 5435
Index EUROPEAN PHARMACOPOEIA 5.8
Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285
Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................. 272
Tubocurarine chloride ............................................................2644Tubocurarini chloridum........................................................2644Turmeric, javanese...................................................................2645Turpentine oil, Pinus pinaster type ..............................5.6-4703Tylosin for veterinary use ...............................................5.4-4035Tylosini phosphatis solutio ad usum veterinarium .........5.4-4037
Tylosini tartras ad usum veterinarium ......................5.4-4039Tylosin phosphate bulk solution for veterinary use ..5.4-4037Tylosin tartrate for veterinary use ................................5.4-4039Tylosinum ad usum veterinarium ...............................5.4-4035Typhoid polysaccharide vaccine ............................................. 705Typhoid vaccine.......................................................................... 707Typhoid vaccine, freeze-dried.................................................. 707Typhoid vaccine (live, oral, strain Ty 21a)............................ 708Tyrosine...................................................................................... 2651Tyrosinum................................................................................. 2651Tyrothricin..........................................................................5.1-3028Tyrothricinum...................................................................5.1-3028
UUbidecarenone..........................................................................2657Ubidecarenonum .....................................................................2657Udder-washes .............................................................................. 631Ultraviolet and visible absorption spectrophotometry(2.2.25.) .............................................................................5.6-4383
Ultraviolet ray lamps for analytical purposes (2.1.3.)............17Uncoated tablets................................................................5.8-5239Undecylenic acid ......................................................................2658Uniformity of content of single-dose preparations(2.9.6.) ........................................................................................ 234
Uniformity of dosage units (2.9.40.) .............................5.3-3370Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) .................................................................. 263
Uniformity of mass of single-dose preparations (2.9.5.) .... 233Units of the International System (SI) used in thePharmacopoeia and equivalence with other units(1.) ......................................................................................5.6-4373
VVaccina ad usum humanum .........................................5.8-5231Vaccina ad usum veterinarium ....................................5.3-3387Vaccines, adsorbed, aluminium in (2.5.13.)...........................131Vaccines, adsorbed, calcium in (2.5.14.).................................131Vaccines and immunosera, phenol in (2.5.15.) .....................131Vaccines and immunosera, veterinary, evaluation of efficacy(5.2.7.)................................................................................5.1-2829
Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...............................................................................5.1-2827
Vaccines and immunosera, veterinary, evaluation of thesafety of each batch (5.2.9.) ..........................................5.1-2830
Vaccines for human use...................................................5.8-5231Vaccines for human use, cell substrates for the production of(5.2.3.) ........................................................................................ 455
Vaccines for human use, viral, extraneous agents in(2.6.16.) ...................................................................................... 169
Vaccines for veterinary use.............................................5.3-3387Vaccines, polysaccharide, hexosamines in (2.5.20.)............ 132Vaccines, polysaccharide, methylpentoses in (2.5.21.)....... 133Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............ 132Vaccines, polysaccharide, O-acetyl in (2.5.19.)..................... 132Vaccines, polysaccharide, phosphorus in (2.5.18.) ............. 132Vaccines, polysaccharide, protein in (2.5.16.) .......................131Vaccines, polysaccharide, ribose in (2.5.31.) ........................ 137Vaccines, polysaccharide, sialic acid in (2.5.23.) ................. 133Vaccines, polysaccharide, uronic acids in (2.5.22.)............. 133Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ...........................................................5.1-2825
Vaccines, terminology (5.2.1.) ................................................. 453Vaccines, veterinary, cell cultures for the production of(5.2.4.) ........................................................................................ 458
Vaccines, veterinary, substances of animal origin for theproduction of (5.2.5.) .............................................................. 460
Vaccines, viral live, test for neurovirulence (2.6.18.).......... 172Vaccinum actinobacillosis inactivatum ad suem ............. 784Vaccinum adenovirosidis caninae vivum........................... 738Vaccinum adenovirosis caninae inactivatum ................... 738Vaccinum anaemiae infectivae pulli vivum....................... 769Vaccinum anthracis adsorbatum ab colato culturarum adusum humanum .............................................................5.6-4479
Vaccinum anthracis vivum ad usum veterinarium.......... 715Vaccinum aphtharum epizooticarum inactivatum adruminantes ......................................................................5.1-2860
Vaccinum diphtheriae et tetani adsorbatum ..................... 639Vaccinum diphtheriae et tetani, antigeni-o(-is) minutum,adsorbatum......................................................................5.6-4480
Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)adsorbatum............................................................................... 641
Vaccinum diphtheriae, tetani et pertussis adsorbatum .. 643Vaccinum diphtheriae, tetani et pertussis sine cellulis exelementis praeparatum adsorbatum.........................5.4-3851
5436 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.8 Index
Vaccinum diphtheriae, tetani et poliomyelitidisinactivatum, antigeni-o(-is) minutum, adsorbatum.......5.6-4481
Vaccinum diphtheriae, tetani, pertussis et poliomyelitidisinactivatum adsorbatum ..............................................5.4-3864
Vaccinum diphtheriae, tetani, pertussis, poliomyelitidisinactivatum et haemophili stirpe b coniugatumadsorbatum......................................................................5.4-3866
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et haemophili stirpe b coniugatumadsorbatum......................................................................5.4-3852
Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum et hepatitidis B (ADNr)adsorbatum......................................................................5.4-3854
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatumadsorbatum......................................................................5.4-3856
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum.......................5.6-4483
Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum, hepatitidis B (ADNr),poliomyelitidis inactivatum et haemophili stirpe bconiugatum adsorbatum ..............................................5.4-3858
Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, poliomyelitidis inactivatum ethaemophili stirpe b coniugatum adsorbatum ........5.4-3861
Vaccinum furunculosidis ad salmonidas inactivatum cumadiuvatione oleosa ad iniectionem .................................... 767
Vaccinum haemophili stirpe b coniugatum....................... 662Vaccinum hepatitidis A inactivatum adsorbatum ............ 665Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)adsorbatum............................................................................... 664
Vaccinum hepatitidis A inactivatum virosomale .............. 667Vaccinum hepatitidis B (ADNr)............................................. 670Vaccinum hepatitidis viralis anatis stirpe I vivum .......... 751Vaccinum herpesviris equini inactivatum ......................... 754Vaccinum inactivatum diarrhoeae vituli coronaviroillatae ......................................................................................... 736
Vaccinum viri syncytialis meatus spiritus bovini vivumcryodesiccatum ....................................................................... 733
Vaginal capsules ................................................................5.5-4169Vaginal foams.....................................................................5.5-4169Vaginalia ............................................................................5.5-4168Vaginal preparations ........................................................5.5-4168Vaginal preparations, semi-solid ....................................5.5-4169Vaginal solutions and suspensions, tablets for...........5.5-4169Vaginal solutions, emulsions and suspensions...........5.5-4169Vaginal tablets ...................................................................5.5-4169Vaginal tampons, medicated...........................................5.5-4170Valerianae extractum hydroalcoholicum siccum ....5.7-5137Valerianae radix ...............................................................5.7-5138Valerianae tinctura ..........................................................5.7-5139Valerian dry hydroalcoholic extract..............................5.7-5137Valerian root.......................................................................5.7-5138Valerian tincture................................................................5.7-5139Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :Guidelines.........................................................................5.5-4113
Valine ..........................................................................................2668Valinum .....................................................................................2668Valnemulin hydrochloride for veterinary use ............5.6-4707Valnemulini hydrochloridum ad usum veterinarium .....5.6-4707
Varicella immunoglobulin, human....................................... 1752Varicella vaccine (live)............................................................... 709Vaselinum album..................................................................... 2187Vaselinum flavum ................................................................... 2188Vectors for human use, adenovirus ..............................5.6-4462Vectors for human use, plasmid ....................................5.6-4466Vectors for human use, plasmid, bacterial cells used for themanufacture of ................................................................5.6-4468
Vectors for human use, poxvirus ...................................5.6-4464Vecuronii bromidum .......................................................5.7-5140Vecuronium bromide........................................................5.7-5140Vegetable drugs, determination of essential oils in vegetabledrugs (2.8.12.) ...........................................................................217
Visible particles, particulate contamination (2.9.20.) ........ 255Vitamin A ............................................................................5.6-4710Vitamin A concentrate (oily form), synthetic ..............5.6-4711Vitamin A concentrate (powder form), synthetic .......5.6-4713Vitamin A concentrate (solubilisate/emulsion),synthetic ...........................................................................5.6-4714
Vitaminum A .....................................................................5.6-4710Vitaminum A densatum oleosum ................................5.6-4711Vitaminum A in aqua dispergibile ..............................5.6-4714Vitaminum A pulvis.........................................................5.6-4713Volumetric analysis (4.2.) ................................................5.7-4937Volumetric solutions (4.2.2.)...........................................5.7-4938Volumetric solutions, primary standards for (4.2.1.) ..5.7-4937von Willebrand factor, human .......................................5.6-4606Von Willebrand factor, human, assay of (2.7.21.).......5.5-4120
Water for injections .................................................................2692Water for pharmaceutical use, total organic carbon in(2.2.44.) ........................................................................................ 68
Xylazine hydrochloride for veterinary use ......................... 2716Xylazini hydrochloridum ad usum veterinarium .......... 2716Xylitol...................................................................................5.3-3647Xylitolum ............................................................................5.3-3647Xylometazoline hydrochloride .......................................5.6-4723Xylometazolini hydrochloridum ..................................5.6-4723Xylose..........................................................................................2720Xylosum .....................................................................................2720