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- ありさ さくいし
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6 CONTENTS I. PREFACE II. EUROPEAN PHARMACOPOEIA CONVENTION III. THE EUROPEAN PHARMACOPOEIA COMMISSION and Groups of Experts IV. GENERAL NOTICES and Abbreviations V. METHODS OF ANALYSIS V.1. APPARATUS V.1.1. Droppers V.1.2. Sintered-glass filters (comparative table of porosity) V.1.3. Ultraviolet ray lamps for analytical purposes V.1.4. Sieves V.1.5. Tubes for comparative tests V.2. BIOLOGICAL TESTS V.2.1. Biological safety tests V Sterility V Mycobacterium tuberculosis *V Test for extraneous agents in avian live viral vaccines *V Test for extraneous viruses using fertilised eggs *V Test for avian enceohalo myelitis virus *V Test for leucosis viruses *V Testfor extraneous viruses using cell cultures *V Test for extraneous agents using chicks *V Test for mycoplasmas
7 V Pyrogens V Abnormal toxicity -general test -test applying to vaccines and immunosera for human use -test applying to vaccines and immunosera for veterinary use V Histamine V Depressor substances *V Microbial contamination of products not required to comply with the test for sterility V.2.2. Assays V Antibiotics, microbiological assay -diffusion method -turbidimetric method V Assay of corticotrophin -subcutaneous method -intravenous method V Assay of insulin V Prolongation of insulin effect V Assay of blood coagulation factor VIII *V Assay of heparin V.3. CHEMIcu. METHODS V.3.1. Identification reactions V Ions and groups -Acetates -Acetyl -Alkaloids -Aluminium -Amines, primary aromatic -Ammonium salts -Ammonium salts and salts of volatile bases -Antimony -Arsenic -Barbiturates, non-nitrogen substituted -Benzoates -Bismuth -Bromides -Calcium -Carbonates and bicarbonates -Chlorides -Citrates -Esters -Iodides -Iron -Lactates -Lead -Magnesium -Mercury
8 -Nitrates -Phosphates (orthophosphates) -Potassium -Salicylates -Silicates -Silver -Sodium -Sulphates -Tartrates -Xanthines -Zinc V Identification of steroid hormones by thin-layer chromatography V Identification of fatty oils by thin-layer chromatography V Identification of phenothiazines by thin-layer chromatography V Colour reactions of penicillins and cephalosporins V Odour V.3.2. Limit tests for inorganic impurities V Ammonium V Arsenic V Calcium V Chlorides V Fluorides V Magnesium V Magnesium and alkaline-earth metals V Heavy metals -methods A, B, C, D and E V Iron V Lead in sugars V Phosphates V Potassium V Sulphates V Sulphated ash *V Nickel in poivols V.3.3. Limit tests for various other impurities I Free formaldehyde V Carboy monoxide in medicinal gases V Alkaline impurities in fatty oils V Antioxidants in fatty oils A. Non-polyhydroxy antioxidants B. Polyhydroxy antioxidants C. Antioxidants not extractable with methanol V Foreign oils in fatty oils by thin-layer chromatography V Foreign oils in fatty oils by gas chromatography V Related foreign steroids in steroid hormones V.3.4. Values V Acid value V Ester value
9 V Hydroxyl value V Iodine value V Peroxide value V Saponificatioa value V Unsanoninable matter V.3.5. Assays V Primary aromatic amino nitrogen V.3.5.2:Determination of nitrogen by sulphuric acid digestion -Semi-micro method V Oxygen-flask method V Complexometric titration -Aluminium -Bismuth -Calcium -Lead -Magnesium -Zinc V Noa-aqueous titratioas -bases -halogen salts of organic bases -acids V Determination of water -Semi-micro method V Aluminium in adsorbed vaccines V Calcium in adsorbed vaccines V Phenol in immunosera and vaccines V.4. METHODS IN PHARMACOGNOSY V.4.1. Ash insoluble in hydrochloric acid V.4.2. Foreign matter V.4.3. Stomata and stomatal index V.4.4. Swelling index V.4.5. Essential oils V Water V Foreign esters V Fatty oils and resinified essential oils V Odour and taste V Residue on evaporation V Solubility in alcohol V Assay of 1, 8-cineole V Determination of essential oils in vegetable drugs V.S. PHARMACEUTICAL TECHNICAL PROCEDURES V.5.1. Disintegration tests V Disintegration of tablets and capsules V Disintegration of suppositories and pessaries V.5.2. Uniformity of mass of single-dose preparations V.6. PHYSICAL. AND PHYSICO-CHHEMICAL METHODS
10 V.6.1. Clarity and degree of opalescence of liquids V.6.2. Degree of coloration of liquids V.6.3. Determination of ph V Potentiometric determination of ph V Relationship between reaction of solution, approximate V.6.4. V.6.5. V.6.6. V.6.7. ph and colour of certain indicators Relative density Refractive index Optical rotation Viscosity V Capillary viscometer method V Rotating viscometer method V.6.8. Distillation range V.6.9. Boiling point V Determination of water by distillation V Melting point V Capillary method V Open capillary method V Instantaneous melting point method V Drop point V Freezing point V Amperometric titrations V Potentiometric titration V Fluorimetry V Flame photometry V Atomic absorption spectrophotometry V Absorption spectrophotometry, infrared V Absorption spectrophotometry, ultraviolet and visible V Chromatography V Paper chromatography -ascending -descending V Thin-laver chromatography V Gas chromatography *V Liquid chromatography *V Size-exclusion chromatography V Electrophoresis V Loss on drying *V Nuclear magnetic resonance spectrometry VI. MATERIALS USED FOE, THE MANUFACTURE OF CONTAINERS AND CONTAINERS VI.1. MATERIALS USED FOR TEE MANUFACTURE OF CONTAINERS VI *V Plastic materials
11 * VI Materials based on polyvinyl chloride) for containers for human blood and blood components *VI Polyolefines *VI Polyethylene - low density for containers for preparations for parenteral use and for ophthalmic preparations *VI Polyethylene - high density for containers for preparations for parenteral use *VI Polypropylene for containers for preparations for parenteral use *VI.1.3. Silicones *VI Silicone oil used as a lubricant VI.2. CoNTAINERs VI.2.1. Glass containers for injectable preparations *VI.2.2. Plastic containers *VI Plastic containers and closures *VI Containers for blood and blood components *VI Sterile plastic containers for human blood and blood components *VI Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components *VI Sterile containers of plasticised poly(vinyl chloride) for human blood containing an anticoagulant solution VII. REAGENTS VII.1. REAGENTS, STANDARD SOLUTIONS AND BUFFER SOLUTIONS VII.1.1. Reagents VII.1.2. Standard solutions for limit tests VII.1.3. Buffer solutions VII.2. VOLUMETRIC ANALYSIS VII.2.1. Reference substances for volumetric solutions VII.2.2. Volumetric solutions VIII. ANNEXES VIII.1. TABLE OF RELATIVE ATOMIC MASSES
12 VIII.2. UNITS OF THE INTERNATIONAL SYSTEM (ST) USED IN THE PHARMACOPOEIAND EQUIVALENCE WITH OTHER UNITS VIII.3. TEST FOR STERILITY VIII.3.1. Minimum number of items recommended to be tested in relation to the number of items in the batch VII.3.2. S uggested culture media VTII.4. VIII.5. VIII6. VIII.7. *VIII.8. MICROBIOLOGICAL ASSAY OF ANTIBIOTICS -Recommended micro-organisms -Preparation of inocula -Buffer solutions -Culture media ANTI-A AND ANTI-B HAEMAGGLUTININS (IND MELT METHOD) K-INDEX METHOD FOR DETERMIMNG THE POTENCY OF FOOT- AND-MOUTH DISEASE VACCINE TEST FOR INACTIVATION OF FOOT-AND-MOUTH DISEASE YIRUS MEASUREMENT OF WATERPROOFNESS OF SELF-ADHESIVE PLASTERS *VIII.9. WATER FOR DILUTING CONCENTRATED HAEMODIALYSIS SOLUTIONS *VIII.10. *VIII.11. MICROBIAL CONTAMINATION OF PRODUCTS NOT REQU UD TO COMPLY WITH TIM TEST FOR STERILITY-RECOMMENDED SOLUTION AND CULTURE MEDIA TEST FOR MYCOPLASMAS-RECOMMENDED CULTURE MEDIA * IX. METHODS OF PREPARATION IX.1. METHODS OF STERILISATION X.1.1. Biological indicators for the verification of sterilisation procedures
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本レポートは独立行政法人日本原子力研究開発機構が不定期に発行する成果報告書です 本レポートの入手並びに著作権利用に関するお問い合わせは 下記あてにお問い合わせ下さい なお 本レポートの全文は日本原子力研究開発機構ホームページ (http://www.jaea.go.jp) より発信されています 独立行政法人日本原子力研究開発機構研究技術情報部研究技術情報課 319-1195 茨城県那珂郡東海村白方白根
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