Pursuant to Paragraph 1, Article 41 of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Law No. 145, 1960), the Japanese Pharmacopoeia (Ministerial Notification No. 65, 2011), which has been established as follows*, shall be applied on April 1, 2016. However, in the case of drugs which are listed in the Pharmacopoeia (hereinafter referred to as “previous Pharmacopoeia”) [limited to those listed in the Japanese Pharmacopoeia whose standards are changed in accordance with this notification (hereinafter referred to as“new Pharmacopoeia”)] and have been approved as of April 1, 2016 as prescribed under Paragraph 1, Article 14 of the same law [including drugs the Minister of Health, Labour and Welfare specifies (the Ministry of Health andWelfare Ministerial Notification No. 104, 1994) as of March 31, 2016 as those exempted from marketing approval pursuant to Paragraph 1, Article 14 of the Same Law (hereinafter referred to as “drugs exempted from approval”)], the Name and Standards established in the previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the new Pharmacopoeia before and on September 30, 2017. In the case of drugs which are listed in the new Pharmacopoeia (excluding those listed in the previous Pharmacopoeia) and drugs which have been approved as of April 1, 2016 as prescribed under Paragraph 1, Article 14 of the same law (including those exempted from approval), they may be accepted as those being not listed in the new Pharmacopoeia before and on September 30, 2017. Yasuhisa Shiozaki The Minister of Health, Labour andWelfare

Preface i

The Japanese Pharmacopoeia, Seventeenth 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 27

1.03 Chloride Limit Test 28

1.04 Flame Coloration Test 28

1.05 Mineral Oil Test 28

1.06 Oxygen Flask Combustion Method 28

1.07 Heavy Metals Limit Test 29

1.08 Nitrogen Determination (Semimicro-Kjeldahl Method) 30

1.09 Qualitative Tests 31

1.10 Iron Limit Test 36

1.11 Arsenic Limit Test 37

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 41

2.Physical Methods Chromatography

2.01 Liquid Chromatography 41

2.02 Gas Chromatography 44

2.03 Thin-layer Chromatography 46

2.04 Amino Acid Analysis of Proteins 46

Spectroscopic Methods

2.21 Nuclear Magnetic Resonance Spectroscopy 47

2.22 Fluorometry 49

2.23 Atomic Absorption Spectrophotometry 49

2.24 Ultraviolet-visible Spectrophotometry 51

2.25 Infrared Spectrophotometry 52

Other Physical Methods

2.41 Loss on Drying Test 53

2.42 Congealing Point Determination 54

2.43 Loss on Ignition Test 54

2.44 Residue on Ignition Test 55

2.45 Refractive Index Determination 55

2.46 Residual Solvents 55

2.47 Osmolarity Determination 61

2.48 Water Determination (Karl Fischer Method) 62

2.49 Optical Rotation Determination 65

2.50 Endpoint Detection Methods in Titrimetry 66

2.51 Conductivity Measurement 68

2.52 Thermal Analysis 69

2.53 Viscosity Determination 71

2.54 pH Determination 74

2.55 Vitamin A Assay 75

2.56 Determination of Specific Gravity and Density 76

2.57 Boiling Point and Distilling Range Test 78

2.58 X-Ray Powder Diffraction Method 79

2.59 Test for Total Organic Carbon 83

2.60 Melting Point Determination 84

2.61 Turbidity Measurement 85

2.62 Mass Spectrometry 86

2.63 Inductively Coupled Plasma-Atomic Emission Spectrometry and Inductively Coupled Plasma-Mass Spectrometry 91

2.64 Glycosylation Analysis of Glycoprotein 95

2.65 Methods for Color Matching 96

3.Powder Property Determinations

3.01 Determination of Bulk and Tapped Densities 98

3.02 Specific Surface Area by Gas Adsorption 100

3.03 Powder Particle Density Determination 103

3.04 Particle Size Determination 104

3.05 Water-Solid Interactions: Determination of Sorption-Desorption Isotherms and of Water Activity 108

4.Biological Tests/Biochemical Tests/Microbial Tests

4.01 Bacterial Endotoxins Test 110

4.02 Microbial Assay for Antibiotics 114

4.03 Digestion Test 117

4.04 Pyrogen Test 120

4.05 Microbiological Examination of Non-sterile Products 121

4.06 Sterility Test 130

5.Tests for Crude Drugs

5.01 Crude Drugs Test 134

5.02 Microbial Limit Test for Crude Drugs and Preparations containing Crude Drugs as Main Ingredient 138

6.Tests for Preparations

6.01 Test for Metal Particles in Ophthalmic Ointments 147

6.02 Uniformity of Dosage Units 147

6.03 Particle Size Distribution Test for Preparations 150

6.04 Test for Acid-neutralizing Capacity of Gastrointestinal Medicines 150

6.05 Test for Extractable Volume of Parenteral Preparations 150

6.06 Foreign Insoluble Matter Test for Injections 151

6.07 Insoluble Particulate Matter Test for Injections 151

6.08 Insoluble Particulate Matter Test for Ophthalmic Solutions 154

6.09 Disintegration Test 155

6.10 Dissolution Test 157

6.11 Foreign Insoluble Matter Test for Ophthalmic Liquids and Solutions 161

6.12 Methods of Adhesion Testing 161

6.13 Release Test for Preparations for Cutaneous Application 163

7.Tests for Containers and Packing Materials

7.01 Test for Glass Containers for Inj ections 166

7.02 Test Methods for Plastic Containers 167

7.03 Test for Rubber Closure for Aqueous Infusions 172

9.Reference Standards; Standard Solutions; Reagents, Test Solutions; Measuring Instruments, Appliances, etc. Reference Standards

9.01 Reference Standards 174

Standard Solutions

9.21 Standard Solutions for Volumetric Analysis 177

9.22 Standard Solutions 189

9.23 Matching Fluids for Color 191

Reagents, Test Solutions, etc.

9.41 Reagents, Test Solutions 191

9.42 Solid Supports/Column Packings for Chromatography 352

9.43 Filter Papers, Filters for filtration, Test Papers, Crucibles, etc 354

9.44 Standard Particles, etc 355

Measuring Instruments and Appliances, Thermometers, etc.

9.61 Optical Filters for Wavelength and Transmission Rate Calibration 355

9.62 Measuring Instruments, Appliances 355

9.63 Thermometers 356

Official Monographs 359

Crude Drugs and Related Drugs 1791

Infrared Reference Spectra 2015-2222

Ultraviolet-visible Reference Spectra 2225-2405

General Information

G1 Physics and Chemistry

Near Infrared Spectrometry 2409

pH Test for Gastrointestinal Medicine 2412

System Suitability 2412

Test for Trace Amounts of Aluminum in Total Parenteral Nutrition (TPN) Solutions 2414

Validation of Analytical Procedures 2415

G2 Solid-state Properties Laser Diffraction Measurement of Particle Size 2418

Measurement of the Diameter of Particles Dispersed in Liquid by Dynamic Light Scattering 2422

Powder Fineness 2424

Powder Flow 2425

Solid and Particle Densities 2427

G3 Biotechnological/Biological Products

Amino Acid Analysis 2428

Basic Requirements for Viral Safety of Biotechnological/Biological Products listed in Japanese Pharmacopoeia 2435

Capillary Electrophoresis 2447

Isoelectric Focusing 2452

Mass Spectrometry of Peptides and Proteins 2454

Monosaccharide Analysis and Oligosaccharide Analysis/Oligosaccharide Profiling 2456

Mycoplasma Testing for Cell Substrates used for the Production of Biotechnological/Biological Products 2460

Peptide Mapping 2464

Qualification of Animals as Origin of Animal-derived Medicinal Products provided in the General Notices of Japanese Pharmacopoeia and Other Standards 2467

SDS-Polyacrylamide Gel Electrophoresis 2469

Surface Plasmon Resonance 2474

Total Protein Assay 2478

G4 Microorganisms

Decision of Limit for Bacterial Endotoxins 2481

Disinfection and Decontamination Methods 2481

Media Fill Test (Process Simulation) 2484

Microbial Attributes of Non-sterile Pharmaceutical Products 2486

Microbiological Environmental Monitoring Methods of Processing Areas for Sterile Pharmaceutical Products 2489

Parametric Release of Terminally Sterilized Pharmaceutical Products 2494

Preservatives-Effectiveness Tests 2499

Rapid Counting of Microbes using Fluorescent Staining 2501

Rapid Identification of Microorganisms Based on Molecular Biological Method 2503

Rapid Microbial Methods 2505

Sterilization and Sterilization Indicators 2507

G5 Crude Drugs Analytical Methods for Aflatoxins in Crude Drug and Crude Drug Preparations 2513

Aristolochic Acid 2515

Notification for the Quantitative Marker Constituents of Crude Drugs and Crude Drug Preparations 2515

Purity Tests on Crude Drugs using Genetic Information 2516

Quantitative Analytical Technique Utilizing Nuclear Magnetic Resonance (NMR) Spectroscopy and its Application to Reagents in the Japanese Pharmacopoeia 2519

On the Scientific Names of Crude Drugs listed in the JP 2520

Thin-layer Chromatography for Crude Drugs and Crude Drug Preparations 2534

G6 Drug Formulation

Standard Procedure for Mechanical Calibration of Dissolution Apparatus 2536

Tablet Friability Test 2538

G7 Containers and Package

Basic Requirements and Terms for the Packaging of Pharmaceutical Products 2538

Basic Requirements for Plastic Containers for Pharmaceutical Use and Rubber Closures for Containers for Aqueous Infusions 2542

G8 Water Quality Control of Water for Pharmaceutical Use 2543

Water to be used in the Tests of Drugs 2550

G9 Reference Standards Reference Standards and Reference Materials Specified in the Japanese Pharmacopoeia 2550

G10 Others

Basic Concepts for Quality Assurance of Drug Substances and Drug Products 2553

Basic Concept of Quality Risk Management 2554 International Harmonization Implemented in the Japanese Pharmacopoeia Seventeenth Edition 2557

Appendix

Atomic Weight Table (2010) 2595

Standard Atomic Weights 2010 2596

Index 2599

Index in Latin name 2616

Index in Japanese 2618

中国医科院医学信息研究所