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Японская фармакопея
The Japanese Pharmacopoeia
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Зеркало
CONTENTSNotification
Preface i
The Japanese Pharmacopoeia,Fourteenth Edition, Part I 1-848
General Notices 1
General Rules for Preparations 5
General Tests, Processes and Apparatus 15
1. Absorbance Ratio Method 15
2. Alcohol Number Determination 16
3. Ammonium Limit Test 17
4. Arsenic Limit Test 18
5. Atomic Absorption Spectrophotometry 19
6. Bacterial Endotoxins Test 20
7. Boiling Point and Distilling Range Test 23
8. Chloride Limit Test 24
9. Congealing Point Determination 24
10. Content Uniformity Test 25
11. Crude Drugs Test 25
12. Determination of Specific Gravity and Density 27
13. Digestion Test 28
14. Disintegration Test 31
15. Dissolution Test 33
16. Endpoint Detection Methods in Titrimetry 36
17. Fats and Fatty Oils Test 38
18. Flame Coloration Test 40
19. Fluorometry 40
20. Foreign Insoluble Matter Test for Injection 41
21. Gas Chromatography 41
22. Heavy Metals Limit Test 43
23. Infrared Spectrophotometry 44
24. Insoluble Particulate Matter Test for Injections 45
25. Insoluble Particulate Matter Test for Ophthalmic Solutions 47
26. Iron Limit Test 48
27. Liquid Chromatography 49
28. Loss on Drying Test 51
29. Loss on Ignition Test 51
30. Mass Variation Test 51
31. Melting Point Determination 52
32. Methanol Test 53
33. Methoxyl Assay 53
34. Microbial Assay for Antibiotics 54
35. Microbial Limit Test 58
36. Microbial Limit Test for Crude Drugs 64
37. Mineral Oil Test 70
38. Nitrogen Determination (Semimicro-Kjeldahl Method) 70
39. Nuclear Magnetic Resonance Spectroscopy (1H) 71
40. Optical Rotation Determination 72
41. Osmolarity Determination 72
42. Oxygen Flask Combustion Method 74
43. Paper Chromatography 75
44. Particle Size Distribution Test for Preparations 75
45. pH Determination 75
46. Powder Particle Size Determination 77
47. Pyrogen Test 78
48. Qualitative Tests 79
49. Readily Carbonizable Substances Test 84
50. Refractive Index Determination 85
51. Residual Solvents Test 85
52. Residue on Ignition Test 85
53. Specific Surface Area Determination 86
54. Sterility Test 87
55. Sulfate Limit Test 90
56. Test for Acid-neutralizing Capacity of Gastrointestinal Medicines 90
57. Test for Glass Containers for Injections 91
58. Test for Metal Particles in Ophthalmic Ointments 92
59. Test for Rubber Closure for Aqueous Infusion 92
60. Test for Total Organic Carbon 93
61. Test Methods for Plastic Containers 95
62. Thermal Analysis 101
63. Thin-layer Chromatography 102
64. Ultraviolet-visible Spectrophotometry 103
65. Viscosity Determination 104
66. Vitamin A Assay 107
67. Volatile Contaminants in Ethanol 108
68. Water Determination (Karl Fischer Method) 109
69. X-Ray Powder Diffraction Method 112
70. Reference Standards; Reagents, Test Solutions; Standard Solutions for Volumetric Analysis; Standard Solutions; Matching Fluids for Color; Optical Filters for Wavelength and Transmission Rate Calibration; and Measuring Instruments, Appliances 113
(1) Reference Standards 114
(2) Reagents, Test Solutions 114
(3) Standard Solutions for Volumetric Analysis 201
(4) Standard Solutions 212
(5) Matching Fluids for Color 214
(6) Optical Filters for Wavelength and Transmission Rate Calibration 215
(7) Measuring Instruments, Appliances 215
71. Sterilization and Aseptic Manipulation,and Reverse Osmosis-Ultrafiltration 217
(1) Sterilization and Aseptic Manipulation 217
(2) Reverse Osmosis-Ultrafiltration 217
Official Monographs 219
The Japanese Pharmacopoeia,Fourteenth Edition, Part II 849-1086
General Notices 849
General Rules for Crude Drugs 849
General Rules for Preparations 850
General Tests, Processes and Apparatus 850
Official Monographs 851
Infrared Reference Spectra 1087-1192
Part I 1091
Part II 1190
Ultraviolet-visual Reference Spectra 1193-1302
Part I 1197
PartII 1301
General Information
1. Aristolochic acid 1303
2. Decision of Limit for Bacterial Endotoxins 1303
3. Disinfection and Sterilization Methods 1304
4. Guideline for Residual Solvents, Residual Solvents Tests, and Models for the Test in Monographs 1305
5. International Harmonization Implemented in the Japanese Pharmacopoeia Fourteenth Edition 1307
6. Medial Fill Test 1307
7. Microbial Attributes of Nonsterile Pharmaceutical Products 1310
8. Microbiological Evaluation of Processing Areas for Sterile Pharmaceutical Products 1312
9. Mycoplasma Testing for Cell Substrates used for the Production of Biotechnological/Biological Products 1316
10. pH Test for Gastrointestinal Medicine 1319
11. Plastic Containers for Pharmaceutical Products 1319
12. Preservatives-Effectiveness Tests 1321
13. Sterility Assurance for Terminally Sterilized Pharmaceutical Products 1323
14. Tablet Friability Test 1326
15. Terminal Sterilization and Sterilization Indicators 1327
16. Validation of Analytical Procedures 1330
Index 1333
Index Nominum 1347
Index in Japanese 1349
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