| Notification |
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| Preface |
i
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| The Japanese Pharmacopoeia,Fourteenth Edition, Part I |
1-848
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|
General Notices |
1
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|
General Rules for Preparations |
5
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|
General Tests, Processes and Apparatus |
15
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1.
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Absorbance Ratio Method |
15
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2.
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Alcohol Number Determination |
16
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3.
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Ammonium Limit Test |
17
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4.
|
Arsenic Limit Test |
18
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5.
|
Atomic Absorption Spectrophotometry |
19
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6.
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Bacterial Endotoxins Test
|
20
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7.
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Boiling Point and Distilling Range Test |
23
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8.
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Chloride Limit Test |
24
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9.
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Congealing Point Determination |
24
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10. |
Content Uniformity Test |
25
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11. |
Crude Drugs Test |
25
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12. |
Determination of Specific Gravity and Density |
27
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13. |
Digestion Test |
28
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14. |
Disintegration Test |
31
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|
15. |
Dissolution Test |
33
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|
16. |
Endpoint Detection Methods in Titrimetry |
36
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17. |
Fats and Fatty Oils Test |
38
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18. |
Flame Coloration Test |
40
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19. |
Fluorometry |
40
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20. |
Foreign Insoluble Matter Test for Injection |
41
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21. |
Gas Chromatography |
41
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|
22. |
Heavy Metals Limit Test |
43
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23. |
Infrared Spectrophotometry |
44
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24. |
Insoluble Particulate Matter Test for Injections |
45
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25. |
Insoluble Particulate Matter Test for Ophthalmic Solutions |
47
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26. |
Iron Limit Test |
48
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27. |
Liquid Chromatography |
49
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|
28. |
Loss on Drying Test |
51
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|
29. |
Loss on Ignition Test |
51
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30. |
Mass Variation Test |
51
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|
31. |
Melting Point Determination |
52
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|
32. |
Methanol Test |
53
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|
33. |
Methoxyl Assay |
53
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|
34. |
Microbial Assay for Antibiotics |
54
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|
35. |
Microbial Limit Test |
58
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36. |
Microbial Limit Test for Crude Drugs |
64
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|
37. |
Mineral Oil Test |
70
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|
38. |
Nitrogen Determination (Semimicro-Kjeldahl Method) |
70
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|
39. |
Nuclear Magnetic Resonance Spectroscopy (1H) |
71
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|
40. |
Optical Rotation Determination |
72
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|
41. |
Osmolarity Determination |
72
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|
42. |
Oxygen Flask Combustion Method |
74
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|
43. |
Paper Chromatography |
75
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|
44. |
Particle Size Distribution Test for Preparations |
75
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|
45. |
pH Determination |
75
|
|
46. |
Powder Particle Size Determination |
77
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|
47. |
Pyrogen Test |
78
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48. |
Qualitative Tests |
79
|
|
49. |
Readily Carbonizable Substances Test |
84
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|
50. |
Refractive Index Determination |
85
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|
51. |
Residual Solvents Test |
85
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|
52. |
Residue on Ignition Test |
85
|
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53. |
Specific Surface Area Determination |
86
|
|
54. |
Sterility Test |
87
|
|
55. |
Sulfate Limit Test |
90
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|
56. |
Test for Acid-neutralizing Capacity of Gastrointestinal Medicines |
90
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|
57. |
Test for Glass Containers for Injections |
91
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|
58. |
Test for Metal Particles in Ophthalmic Ointments |
92
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|
59. |
Test for Rubber Closure for Aqueous Infusion |
92
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|
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
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|
67. |
Volatile Contaminants in Ethanol |
108
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|
68. |
Water Determination (Karl Fischer Method) |
109
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|
69. |
X-Ray Powder Diffraction Method |
112
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|
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
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|
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(1) Reference Standards |
114
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(2) Reagents, Test Solutions |
114
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|
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(3) Standard Solutions for Volumetric Analysis |
201
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|
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(4) Standard Solutions |
212
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|
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(5) Matching Fluids for Color |
214
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(6) Optical Filters for Wavelength and Transmission Rate Calibration |
215
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(7) Measuring Instruments, Appliances |
215
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|
71. |
Sterilization and Aseptic Manipulation,and Reverse Osmosis-Ultrafiltration |
217
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(1) Sterilization and Aseptic Manipulation |
217
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(2) Reverse Osmosis-Ultrafiltration |
217
|
|
Official Monographs |
219
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|
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|
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| 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.
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Medial Fill Test |
1307
|
|
7.
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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
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10. |
pH Test for Gastrointestinal Medicine |
1319
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11. |
Plastic Containers for Pharmaceutical Products |
1319
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|
12. |
Preservatives-Effectiveness Tests |
1321
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|
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
|
|
|
|
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| Index |
1333
|
| Index Nominum |
1347
|
| Index in Japanese |
1349
|
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