CONTENTS

This is an old version of The Japanese Pharmacopoeia published in 2001. The latest version is available.
Plese go to http://jpdb.nihs.go.jp/kyokuhou/archives-e.htm.


Notification
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


back to Homepage