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【作者】National Institute of Health Sciences (日本国立医药品食品卫生研究所)

【版本】Fourteenth Edition

【出版日期】April 2001

     "The Japanese Pharmacopoeia Fourteenth Edition Name and Structure Database" is a database which is being developed by Division of Safety Information on Drug, Food and Chemicals and Division of Organic Chemistry in National Institute of Health Sciences. It is open to the public to be evaluated.

This database includes English name, structural formula, molecular formula and molecular mass, chemical name and CAS registry number of "the Japanese Pharmacopoeia Fourteenth Edition, part I (882 articles) and part II (481 articles)".


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

The Japanese Pharmacopoeia,Fourteenth Edition, Part II
General Notices
General Rules for Crude Drugs
General Rules for Preparations
General Tests, Processes and Apparatus
Official Monographs

Infrared Reference Spectra
Part I
Part II

Ultraviolet-visual Reference Spectra
Part I

General Information
1. Aristolochic acid
2. Decision of Limit for Bacterial Endotoxins
3. Disinfection and Sterilization Methods
4. Guideline for Residual Solvents, Residual Solvents Tests, and Models for the Test in Monographs
5. International Harmonization Implemented in the Japanese Pharmacopoeia Fourteenth Edition
6. Medial Fill Test
7. Microbial Attributes of Nonsterile Pharmaceutical Products
8. Microbiological Evaluation of Processing Areas for Sterile Pharmaceutical Products
9. Mycoplasma Testing for Cell Substrates used for the Production of Biotechnological/Biological Products
10. pH Test for Gastrointestinal Medicine
11. Plastic Containers for Pharmaceutical Products
12. Preservatives-Effectiveness Tests
13. Sterility Assurance for Terminally Sterilized Pharmaceutical Products
14. Tablet Friability Test
15. Terminal Sterilization and Sterilization Indicators
16. Validation of Analytical Procedures

Index Nominum
Index in Japanese

     The Japanese Pharmacopoeia documents are in Portable Document Format (PDF).

  美国药典United States Pharmacopeia (USP)
  British Pharmacopoeia (英国药典BritPharm)

Summary by 易锋 on 2004-03-02

Last updated by 李晓霞 on 2004-03-15

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