CONTENTS
Preface……………………………………………………i
The Japanese Pharmacopoeia, Fifteenth
Edition………………………………………………….. 1
General Notices……………………………………… 1
General Rules for Crude Drugs…………………….5
General Rules for Preparations…………………….7
General Tests, Processes and Apparatus…………17
1. Chemical Methods
1.01 Alcohol Number Determination………….. 17
1.02 Ammonium Limit Test……………………. 19
1.03 Chloride Limit Test…………………………20
1.04 Flame Coloration Test…………………….. 20
1.05 Mineral Oil Test……………………………. 20
1.06 Oxygen Flask Combustion Method………. 20
1.07 Heavy Metals Limit Test………………….. 21
1.08 Nitrogen Determination (Semimicro-
Kjeldahl Method)…………………………22
1.09 Qualitative Tests…………………………….23
1.10 Iron Limit Test…………………………….. 28
1.11 Arsenic Limit Test…………………………. 29
1.12 Methanol Test……………………………….30
1.13 Fats and Fatty Oils Test…………………… 31
1.14 Sulfate Limit Test………………………….. 33
1.15 Readily Carbonizable Substances Test…… 33
2. Physical Methods
Chromatographys
2.01 Liquid Chromatography……………………33
2.02 Gas Chromatography……………………… 35
2.03 Thin-layer Chromatography………………. 37
Spectroscopic Methods
2.21 Nuclear Magnetic Resonance
Spectroscopy………………………………38
2.22 Fluorometry………………………………… 40
2.23 Atomic Absorption
Spectrophotometry……………………….40
2.24 Ultraviolet-visible Spectrophotometry…….41
2.25 Infrared Spectrophotometry………………. 43
Other Physical Methods
2.41 Loss on Drying Test……………………….. 44
2.42 Congealing Point Determination…………. 44
2.43 Loss on Ignition Test……………………….45
2.44 Residue on Ignition Test………………….. 45
2.45 Refractive Index Determination………….. 46
2.46 Residual Solvents Test…………………….. 46
2.47 Osmolarity Determination………………… 46
2.48 Water Determination (Karl Fischer
Method)……………………………………47
2.49 Optical Rotation Determination………….. 50
2.50 Endpoint Detection Methods in
Titrimetry………………………………… 51
2.51 Conductivity Measurement……………….. 53
2.52 Thermal Analysis……………………………54
2.53 Viscosity Determination…………………… 56
2.54 pH Determination…………………………..59
2.55 Vitamin A Assay…………………………… 60
2.56 Determination of Specific Gravity and
Density……………………………………. 61
2.57 Boiling Point and Distilling Range
Test……………………………………….. 63
2.58 X-Ray Powder Diffraction Method……… 64
2.59 Test for Total Organic Carbon…………… 65
2.60 Melting Point Determination………………66
3. Powder Property Determinations
3.01 Determination of Bulk and Tapped
Densities………………………………….. 68
3.02 Specific Surface Area by Gas
Adsorption……………………………….. 69
3.03 Powder Particle Density
Determination……………………………. 71
3.04 Particle Size Determination………………..72
4. Biological Tests/Biochemical Tests/
Microbial Tests
4.01 Bacterial Endotoxins Test…………………. 77
4.02 Microbial Assay for Antibiotics………….. 81
4.03 Digestion Test………………………………. 84
4.04 Pyrogen Test……………………………….. 87
4.05 Microbial Limit Test………………………. 88
4.06 Sterility Test………………………………… 93
5. Tests for Crude Drugs
5.01 Crude Drugs Test………………………….. 97
5.02 Microbial Limit Test for Crude Drugs…. 100
6. Tests for Preparations
6.01 Test for Metal Particles in Ophthalmic
Ointments………………………………..106
6.02 Uniformity of Dosage Units…………….. 106
6.03 Particle Size Distribution Test for
Preparations……………………………..109
6.04 Test for Acid-neutralizing Capacity of
Gastrointestinal Medicines……………..109
6.05 Test for Extractable Volume of
Parenteral Preparations……………….. 110
6.06 Foreign Insoluble Matter Test for
Injections……………………………….. 110
6.07 Insoluble Particulate Matter Test for
Injections……………………………….. 111
6.08 Insoluble Particulate Matter Test for
Ophthalmic Solutions…………………..113
6.09 Disintegration Test……………………….. 114
6.10 Dissolution Test…………………………… 116
Contents JP XV
7. Tests for Containers and Packing Materials
7.01 Test for Glass Containers for Injections.. 120
7.02 Test Methods for Plastic Containers…….121
7.03 Test for Rubber Closure for Aqueous
Infusions………………………………… 127
8. Other Methods
8.01 Sterilization and Aseptic Manipulation,
and Reverse Osmosis-Ultrafiltration…. 128
9. Reference Standards; Standard Solutions;
Reagents, Test Solutions; Measuring
Instruments, Appliances, Thermometers,
etc.
Reference Standards
9.01 Reference Standards……………………… 129
Standard Solutions
9.21 Standard Solutions for Volumetric
Analysis…………………………………. 132
9.22 Standard Solutions……………………….. 143
9.23 Matching Fluids for Color………………. 145
Reagents, Test Solutions, etc.
9.41 Reagents, Test Solutions…………………. 146
9.42 Solid Supports/Column Packing for
Chromatography……………………….. 259
9.43 Filter Paper, Filters for Filtration,
Test Papers, Crucibles, etc……………. 261
9.44 Reference Particles, etc……………………261
Measuring Instruments and Appliances,
Thermometers, etc.
9.61 Optical Filters for Wavelength and
Transmission Rate Calibration……….. 262
9.62 Measuring Instruments, Appliances……..262
9.63 Thermometers…………………………….. 263
Official Monographs……………………………….. 265
Crude Drugs…………………………………….. 1251
Infrared Reference Spectra………………… 1373–1518
Ultraviolet-visible Reference Spectra……… 1519–1654
General Information
1. Amino Acid Analysis……………………….. 1655
2. Aristolochic Acid……………………………. 1662
3. Basic Requirements for Viral Safety of
Biotechnological/Biological Products
listed in Japanese Pharmacopoeia………. 1663
4. Capillary Electrophoresis…………………… 1675
5. Decision of Limit for Bacterial
Endotoxins………………………………… 1680
6. Disinfection and Sterilization Methods…….1680
7. Guideline for Residual Solvents, Residual
Solvents Test, and Models for the Test in
Monographs………………………………..1682
8. International Harmonization
Implemented in the Japanese
Pharmacopoeia Fifteenth Edition………. 1684
9. Isoelectric Focusing…………………………. 1708
10. Laser Diffraction Measurement of
Particle Size……………………………….. 1710
11. Media Fill Test………………………………. 1712
12. Microbial Attributes of Nonsterile
Pharmaceutical Products………………… 1715
13. Microbiological Evaluation of Processing
Areas for Sterile Pharmaceutical
Products…………………………………….1717
14. Mycoplasma Testing for Cell Substrates
used for the Production of
Biotechnological/Biological Products….. 1721
15. Peptide Mapping……………………………..1724
16. pH Test for Gastrointestinal Medicine……. 1727
17. Plastic Containers for Pharmaceutical
Products…………………………………….1728
18. Powder Flow………………………………….1729
19. Preservatives-Effectiveness Tests……………1732
20. Qualification of Animals as Origin of
Animal-derived Medicinal Products
provided in the General Notices of
Japanese Pharmacopoeia and Other
Standards………………………………….. 1734
21. Quality Control of Water for
Pharmaceutical Use………………………. 1736
22. Rapid Identification of Microorganisms
Based on Molecular Biological Method… 1740
23. SDS-Polyacrylamide Gel Electrophoresis…. 1742
24. Solid and Particle Densities………………… 1746
25. Sterility Assurance for Terminally
Sterilized Pharmaceutical Products…….. 1748
26. Tablet Friability Test……………………….. 1751
27. Terminal Sterilization and Sterilization
Indicators………………………………….. 1752
28. Test for Trace Amounts of Aluminum in
Trans Parenteral Nutrition (TPN)
Solutions…………………………………… 1754
29. Total Protein Assay…………………………. 1756
30. Validation of Analytical Procedures………. 1760
Appendix
Atomic Weight Table (2004)……………………… 1763
Standard Atomic Weights 2004………………….. 1764
Index………………………………………………… 1765
Index in Latin name………………………………. 1777
Index in Japanese…………………………………..1779
