دانلود کتاب فارماکوپه ژاپن 2025 خرید ایبوک Japanese Pharmacopoeia 2021

JP18th Edition [June 7, 2021, the MHLW Ministerial Notification No. 220]
General Notice – General Tests,Processes and Apparatus [5,792KB]PDF
Official Monographs(A to L) [11,728KB]PDF
Official Monographs(M to Z) [8,481KB]PDF
Crude Drugs and Related Drugs [2,766KB]PDF
Infrared Reference Spectra [15,169KB]PDF
Ultraviolet-visible Reference Spectra [16,823KB]
General Information [2,661KB]PDF
Note: the links above all lead to the files on the MHLW website.

JP18th Edition Errata [96.2KB]PDF [Issued in June 3, 2022, September 14, 2022, November 10, 2023, November 29, 2024, October 14, 2025 and March 4, 2026]

JP18th Edition Supplement l [3,286KB]PDF [December 12, 2022, the MHLW Ministerial Notification No. 355]
Note: the link lead to the file on the MHLW website.

​JP18th Edition Supplement I Errata​ [91.8KB]PDF [Issued in July 17, 2024]

JP18th Edition Supplement II [2.8MB]PDF [June 28, 2024, the MHLW Ministerial Notification No. 238]
Note: the link lead to the file on the MHLW website.

JP18th Edition Supplement II Errata [26.1KB]PDF [Issued in October 14, 2025]

فهرست مطالب Japanese Pharmacopoeia (2021)

CONTENTS
Preface……………………………………………………i
The Japanese Pharmacopoeia, Eighteenth Edition …1
General Notices………………………………………1
General Rules for Crude Drugs…………………….5
General Rules for Preparations…………………….7
General Tests, Processes and Apparatus…………25

1. Chemical Methods
   1.01 Alcohol Number Determination …………..25
   1.02 Ammonium Limit Test …………………….26
   1.03 Chloride Limit Test…………………………27
   1.04 Flame Coloration Test ……………………..27
   1.05 Mineral Oil Test …………………………….28
   1.06 Oxygen Flask Combustion Method……….28
   1.07 Heavy Metals Limit Test …………………..29
   1.08 Nitrogen Determination (SemimicroKjeldahl Method)…………………………30
   1.09 Qualitative Tests…………………………….31
   1.10 Iron Limit Test ……………………………..36
   1.11 Arsenic Limit Test ………………………….36
   1.12 Methanol Test……………………………….38
   1.13 Fats and Fatty Oils Test……………………38
   1.14 Sulfate Limit Test…………………………..40
   1.15 Readily Carbonizable Substances Test ……40
2. Physical Methods
   Chromatography
   2.01 Liquid Chromatography……………………41
   2.02 Gas Chromatography ………………………44
   2.03 Thin-layer Chromatography……………….45
   2.04 Amino Acid Analysis of Proteins …………46
   2.05 Size-Exclusion Chromatography…………..47
   Spectroscopic Methods
   2.21 Nuclear Magnetic Resonance
   Spectroscopy………………………………48
   2.22 Fluorometry …………………………………50
   2.23 Atomic Absorption
   Spectrophotometry……………………….50
   2.24 Ultraviolet-visible Spectrophotometry…….51
   2.25 Infrared Spectrophotometry……………….53
   2.26 Raman Spectroscopy ……………………….54
   Other Physical Methods
   2.41 Loss on Drying Test………………………..56
   2.42 Congealing Point Determination ………….56
   2.43 Loss on Ignition Test……………………….57
   2.44 Residue on Ignition Test …………………..57
   2.45 Refractive Index Determination …………..58
   2.46 Residual Solvents……………………………58
   2.47 Osmolarity Determination …………………64
   2.48 Water Determination (Karl Fischer
   Method)……………………………………65
   2.49 Optical Rotation Determination …………..68
   2.50 Endpoint Detection Methods in
   Titrimetry …………………………………69
   2.51 Conductivity Measurement ………………..70
   2.52 Thermal Analysis……………………………72
   2.53 Viscosity Determination ……………………75
   2.54 pH Determination…………………………..77
   2.55 Vitamin A Assay ……………………………79
   2.56 Determination of Specific Gravity and
   Density…………………………………….80
   2.57 Boiling Point and Distilling Range
   Test ………………………………………..81
   2.58 X-Ray Powder Diffraction Method ………82
   2.59 Test for Total Organic Carbon ……………86
   2.60 Melting Point Determination………………87
   2.61 Turbidity Measurement…………………….89
   2.62 Mass Spectrometry………………………….90
   2.63 Inductively Coupled Plasma-Atomic
   Emission Spectrometry and Inductively
   Coupled Plasma-Mass Spectrometry …..94
   2.64 Glycosylation Analysis of Glycoprotein ….98
   2.65 Methods for Color Matching …………….100
   2.66 Elemental Impurities………………………102
3. Powder Property Determinations
   3.01 Determination of Bulk and Tapped
   Densities………………………………….108
   3.02 Specific Surface Area by Gas
   Adsorption ………………………………110
   3.03 Powder Particle Density
   Determination …………………………..113
   3.04 Particle Size Determination ………………114
   3.05 Water-Solid Interactions: Determination of
   Sorption-Desorption Isotherms and of
   Water Activity…………………………..118
   3.06 Laser Diffraction Measurement of Particle
   Size ……………………………………….120
4. Biological Tests/Biochemical Tests/
   Microbial Tests
   4.01 Bacterial Endotoxins Test ………………..124
   4.02 Microbial Assay for Antibiotics………….127
   4.03 Digestion Test ……………………………..131
   4.04 Pyrogen Test……………………………….133
   4.05 Microbiological Examination of Non-sterile
   Products………………………………….134
   4.06 Sterility Test………………………………..144
5. Tests for Crude Drugs
   5.01 Crude Drugs Test………………………….147
   5.02 Microbial Limit Test for Crude Drugs and
   Preparations containing Crude Drugs as
   Main Ingredient …………………………152
6. Tests for Preparations6.01 Test for Metal Particles in OphthalmicOintments………………………………..1616.02 Uniformity of Dosage Units ……………..1616.03 Particle Size Distribution Test forPreparations……………………………..1636.04 Test for Acid-neutralizing Capacity of
7. Contents JP XVIII
8. Gastrointestinal Medicines……………..164
9. 6.05 Test for Extractable Volume of
10. Parenteral Preparations ………………..164
11. 6.06 Foreign Insoluble Matter Test for
12. Injections ………………………………..165
13. 6.07 Insoluble Particulate Matter Test for
14. Injections ………………………………..165
15. 6.08 Insoluble Particulate Matter Test for
16. Ophthalmic Solutions…………………..168
17. 6.09 Disintegration Test ………………………..169
18. 6.10 Dissolution Test……………………………170
19. 6.11 Foreign Insoluble Matter Test for
20. Ophthalmic Liquids and Solutions ……174
21. 6.12 Methods of Adhesion Testing ……………175
22. 6.13 Release Test for Preparations for Cutaneous
23. Application………………………………177
24. 6.14 Uniformity of Delivered Dose for Inhalations
25. ……………………………………………180
26. 6.15 Aerodynamic Particle Size Measurement for
27. Inhalations……………………………….183
28. 6.16 Rheological Measurements for Semi-solid
29. Preparations……………………………..191
30. 6.17 Insoluble Particulate Matter Test for
31. Therapeutic Protein Injections ………..194
32. 7. Tests for Containers and Packing Materials
33. 7.01 Test for Glass Containers for Injections..195
34. 7.02 Test Methods for Plastic Containers…….196
35. 7.03 Test for Rubber Closure for Aqueous
36. Infusions …………………………………201
37. 9. Reference Standards; Standard Solutions;
38. Reagents, Test Solutions; Measuring
39. Instruments, Appliances, etc.
40. Reference Standards
41. 9.01 Reference Standards ………………………203
42. Standard Solutions
43. 9.21 Standard Solutions for Volumetric
44. Analysis ………………………………….207
45. 9.22 Standard Solutions ………………………..218
46. 9.23 Matching Fluids for Color ……………….221
47. Reagents, Test Solutions, etc.
48. 9.41 Reagents, Test Solutions………………….221
49. 9.42 Solid Supports/Column Packings for
50. Chromatography………………………..391
51. 9.43 Filter Papers, Filters for filtration,
52. Test Papers, Crucibles, etc. ……………394
53. 9.44 Standard Particles, etc…………………….394
54. Measuring Instruments and Appliances,
55. Thermometers, etc.
56. 9.61 Optical Filters for Wavelength and
57. Transmission Rate Calibration ………..395
58. 9.62 Measuring Instruments, Appliances……..395
59. 9.63 Thermometers ……………………………..396
60. Official Monographs ………………………………..399
61. Crude Drugs and Related Drugs……………….1939
62. Infrared Reference Spectra …………………2179–2395
63. Ultraviolet-visible Reference Spectra ………2399–2587
64. General Information
65. G0 Basic Concepts on Pharmaceutical Quality
66. Basic Concepts for Quality Assurance of Drug
67. Substances and Drug Products
68. ……………………………………………….2591
69. Basic Concept of Quality Risk Management
70. ……………………………………2593
71. Concept on Impurities in Chemically synthesized
72. Drug Substances and Drug Products
73. ……………………………………………….2596
74. Stability Testing of Drug Substances and Drug
75. Products ………………………..2598
76. Basic Requirements and Terms for the Packaging
77. of Pharmaceutical Products ….2601
78. Glossary for Quality by Design (QbD), Quality
79. Risk Management (QRM) and Pharmaceutical
80. Quality System (PQS) …………2604
81. G1 Physics and Chemistry
82. Validation of Analytical Procedures
83. ……………………………………………….2607
84. System Suitability ………………..2609
85. Near Infrared Spectrometry …….2611
86. G2 Solid-state Properties
87. Solid and Particle Densities ……..2614
88. Powder Fineness ………………….2615
89. Powder Flow ……………………..2616
90. Measurement of the Diameter of Particles
91. Dispersed in Liquid by Dynamic Light
92. Scattering ……………………….2618
93. G3 Biotechnological/Biological Products
94. Basic Concept of the Quality Control on
95. Biotechnological Products
96. (Biopharmaceuticals) ………….2621
97. Amino Acid Analysis ……………2625
98. Peptide Mapping …………………2632
99. Mass Spectrometry of Peptides and Proteins
100. ……………………………………2635
101. Monosaccharide Analysis and Oligosaccharide
102. Analysis/Oligosaccharide Profiling
103. ……………………………………………….2637
104. Isoelectric Focusing ………………2641
105. Capillary Electrophoresis ………..2643
106. SDS-Polyacrylamide Gel Electrophoresis
107. ……………………………………2648
108. Host Cell Protein Assay …………2653
109. Surface Plasmon Resonance …..2656
110. Enzyme-linked Immunosorbent Assay (ELISA)
111. ………………………………….2659
112. Total Protein Assay …………….2662
113. Basic Requirements for Viral Safety of
114. Biotechnological/Biological Products listed in
115. Japanese Pharmacopoeia …..2666
116. Mycoplasma Testing for Cell Substrates used for
117. the Production of Biotechnological/Biological
118. Products ……………………….2678JP XVIII Contents
119. Qualification of Animals as Origin of
120. Animal-derived Medicinal Products provided
121. in the General Notices of Japanese
122. Pharmacopoeia and Other Standards
123. ………………………………….2682
124. G4 Microorganisms
125. Microbial Attributes of Non-sterile
126. Pharmaceutical Products ……..2684
127. Control of Culture Media and Strains of
128. Microorganisms Used for Microbial Tests
129. ……………………………………2686
130. Preservatives-Effectiveness Tests
131. ……………………………………………….2688
132. Bacterial Endotoxins Test and Alternative
133. Methods using Recombinant Protein-reagents
134. for Endotoxin Assay ………….2691
135. Decision of Limit for Bacterial Endotoxins
136. ……………………………………2693
137. Rapid Microbial Methods ……….2693
138. Rapid Identification of Microorganisms Based
139. on Molecular Biological Method
140. ……………………………………………….2695
141. Rapid Counting of Microbes using Fluorescent
142. Staining …………………………2696
143. Disinfection and Decontamination Methods
144. ……………………………………2698
145. Sterilization and Sterilization Indicators
146. ………………………………….2701
147. G5 Crude Drugs
148. On the Scientific Names of Crude Drugs listed in
149. the JP …………………………..2707
150. Notification for the Quantitative Marker
151. Constituents of Crude Drugs and Crude Drug
152. Preparations …………………..2721
153. Thin-layer Chromatography for Crude Drugs
154. and Crude Drug Preparations
155. ……………………………………………….2722
156. Aristolochic Acid …………………2724
157. Quantitative Analytical Technique Utilizing
158. Nuclear Magnetic Resonance (NMR)
159. Spectroscopy and its Application to Reagents
160. in the Japanese Pharmacopoeia
161. ……………………………………………….2724
162. Purity Tests on Crude Drugs using Genetic
163. Information …………………….2726
164. Analytical Methods for Aflatoxins in Crude Drug
165. and Crude Drug Preparations
166. ……………………………………………….2730
167. Radioactivity Measurements Method for Crude
168. Drugs ……………………………2731
169. G6 Drug Formulation
170. Criteria for Content Uniformity in Real Time
171. Release Testing by Process Analytical
172. Technology …………………….2737
173. Standard Procedure for Mechanical Calibration
174. of Dissolution Apparatus …….2739
175. Aerodynamic Particle Size Measurement for
176. Inhalations by Glass Impingers
177. ……………………………………………….2741
178. Tablet Hardness Determinations
179. ……………………………………………….2743
180. Tablet Friability Test …………….2744
181. pH Test for Gastrointestinal Medicine
182. ……………………………………………….2744
183. Test for Trace Amounts of Aluminum in Total
184. Parenteral Nutrition (TPN) Solutions
185. ……………………………………2744
186. G7 Containers and Package
187. Glass Containers for Pharmaceutical Products
188. ……………………………………2746
189. Basic Requirements for Plastic Containers for
190. Pharmaceutical Use and Rubber Closures for
191. Containers for Aqueous Infusions
192. ……………………………………………….2748
193. Moisture Permeability Test for Blister Packaging
194. of Solid Preparations ………..2749
195. Packaging Integrity Evaluation of Sterile
196. Products ………………………..2750
197. Leak Tests for Packaging of Sterile Products
198. ……………………………………2753
199. G8 Reference Standards
200. Reference Standards and Reference Materials
201. Specified in the Japanese Pharmacopoeia
202. ……………………………………2756
203. GZ Others
204. Water to be used in the Tests of Drugs
205. ……………………………………………….2758
206. Quality Control of Water for Pharmaceutical
207. Use ……………………………..2759
208. International Harmonization Implemented in the
209. Japanese Pharmacopoeia Eighteenth Edition
210. …………………………………..2765
211. Appendix
212. Atomic Weight Table (2017) ………………………2769
213. Standard Atomic Weights 2017 …………………..2771
214. Standard Atomic Weights 2010 …………………..2773
215. Index…………………………………………………2775
216. Index in Latin name ……………………………….2793
217. Index in Japanese…………………………………..2795