The Ministry of Health, Labour and Welfare Ministerial ...

1 The Ministry of Health, Labour and Welfare Ministerial Notification No. 220. Pursuant to Paragraph 1, Article 41 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Law No. 145, 1960), this notifica- tion stated that the Japanese Pharmacopoeia was revised as follows*. TAMURA Norihisa The Minister of Health, Labour and Welfare June 7, 2021. Japanese Pharmacopoeia Pursuant to Paragraph 1, Article 41 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Law No. 145, 1960), the Japanese Pharmacopoeia was revised as follows. (The text referred to by the term ``as follows'' are omitted here. All of the revised Japanese Pharmacopoeia in accordance with this notification are made available for public exhibition at the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare , at each Regional Bureau of Health and Welfare , and at each Prefectural Office in Japan).

2 Supplementary Provisions (Effective Date). Article 1 This Notification is applied from the date of the notification. (referred to as the ``notification date'' in the next and third articles). (Transitional measures). Article 2 In the case of drugs which are listed in the Japanese Pharmacopoeia (hereinafter referred to as ``previous Pharmacopoeia'') and have been approved as of the notification date as prescribed under Paragraph 1, Article 14 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices [including drugs the Minister of Health, Labour and Welfare specifies (the Ministry of Health and Welfare Ministerial Notification No. 104, 1994) as of the day before the notification date 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 es- tablished 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 revised Japanese Pharmacopoeia (hereinafter referred to as ``new Pharmacopoeia'') (limit- ed to part of the Name and Standards for the drugs concerned) in accordance with this notification before and on December 31, 2022.

3 Article 3 In the case of drugs which are listed in the new Pharmacopoeia (excluding those listed in the previous Pharmacopoeia) and have been approved as of the notification date as prescribed under the 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 December 31, 2022. Article 4 In the case of drugs which are listed in the new Pharmacopoeia, their commonly used names established in the previous Pharmacopoeia may be accepted to conform to the Name established in the new Pharmacopoeia before and on June 30, 2024. Article 5 In the case of drugs which are listed in the new Pharmacopoeia, the previous provi- sions are applied before and on June 30, 2024, regardless of the Paragraph 34 of General Notices. *The term ``as follows'' here indicates the contents of the Japanese Pharmacopoeia Eighteenth Edi- tion from General Notice to Ultraviolet-Visible Reference Spectra (pp.)

4 1 2587). Contents Endpoint Detection Methods in CONTENTS Titrimetry ..69. Conductivity Measurement ..70. Thermal Viscosity Determination ..75. pH The Japanese Pharmacopoeia, Eighteenth Edition ..1 Vitamin A Assay ..79. General Notices ..1 Determination of Specific Gravity and Density ..80. General Rules for Crude Boiling Point and Distilling Range General Rules for Test ..81. X-Ray Powder Diffraction Method ..82. General Tests, Processes and Test for Total Organic Carbon ..86. 1. Chemical Methods Melting Point Alcohol Number Determination ..25. Turbidity Measurement ..89. Ammonium Limit Test ..26. Mass Chloride Limit Inductively Coupled Plasma-Atomic Flame Coloration Test ..27. Emission Spectrometry and Inductively Mineral Oil Test ..28. Coupled Plasma-Mass Spectrometry ..94. Oxygen Flask Combustion Glycosylation Analysis of Glycoprotein ..98. Heavy Metals Limit Test ..29. Methods for Color Matching ..100. Nitrogen Determination (Semimicro- Elemental Impurities.

5 102. Kjeldahl Method)..30. 3. Powder Property Determinations Qualitative Determination of Bulk and Tapped Iron Limit Test ..36. Arsenic Limit Test ..36. Specific Surface Area by Gas Methanol Adsorption ..110. Fats and Fatty Oils Test ..38. Powder Particle Density Sulfate Limit Test ..40. Determination ..113. Readily Carbonizable Substances Test ..40. Particle Size Determination ..114. 2. Physical Methods Water-Solid Interactions: Determination of Chromatography Sorption-Desorption Isotherms and of Liquid Water Activity ..118. Gas Chromatography ..44. Laser Diffraction Measurement of Particle Thin-layer Chromatography ..45. Size ..120. Amino Acid Analysis of Proteins ..46. 4. Biological Tests/Biochemical Tests/. Size-Exclusion Microbial Tests Spectroscopic Methods Bacterial Endotoxins Test ..124. Nuclear Magnetic Resonance Microbial Assay for Digestion Test ..131. Fluorometry ..50. Pyrogen Test ..133. Atomic Absorption Microbiological Examination of Non-sterile Ultraviolet-visible Sterility Infrared Spectrophotometry.

6 53. 5. Tests for Crude Drugs Raman Spectroscopy ..54. Crude Drugs Test ..147. Other Physical Methods Microbial Limit Test for Crude Drugs and Loss on Drying Test ..56. Preparations containing Crude Drugs as Congealing Point Determination ..56. Main Ingredient ..152. Loss on Ignition 6. Tests for Preparations Residue on Ignition Test ..57. Test for Metal Particles in Ophthalmic Refractive Index Determination ..58. Residual Uniformity of Dosage Units ..161. Osmolarity Determination ..64. Particle Size Distribution Test for Water Determination (Karl Fischer Method)..65. Test for Acid-neutralizing Capacity of Optical Rotation Determination ..68. Contents JP XVIII. Gastrointestinal Ultraviolet-visible Reference Spectra ..2399 2587. Test for Extractable Volume of General Information Parenteral Preparations ..164. G0 Basic Concepts on Pharmaceutical Quality Foreign Insoluble Matter Test for Basic Concepts for Quality Assurance of Drug Injections.

7 165. Substances and Drug Products <G0-1-172>. Insoluble Particulate Matter Test for ..2591. Injections ..165. Basic Concept of Quality Risk Management Insoluble Particulate Matter Test for <G0-2-170>..2593. Ophthalmic Concept on Impurities in Chemically synthesized Disintegration Test ..169. Drug Substances and Drug Products <G0-3-172>. Dissolution Test ..170..2596. Foreign Insoluble Matter Test for Stability Testing of Drug Substances and Drug Ophthalmic Liquids and Solutions ..174. Products <G0-4-171> ..2598. Methods of Adhesion Testing ..175. Basic Requirements and Terms for the Packaging Release Test for Preparations for Cutaneous of Pharmaceutical Products <G0-5-170> ..2601. Application ..177. Glossary for Quality by Design (QbD), Quality Uniformity of Delivered Dose for Inhalations Risk Management (QRM) and Pharmaceutical ..180. Quality System (PQS) <G0-6-172> ..2604. Aerodynamic Particle Size Measurement for G1 Physics and chemistry Validation of Analytical Procedures <G1-1-130>.

8 Rheological Measurements for Semi-solid ..2607. System Suitability <G1-2-152> ..2609. Insoluble Particulate Matter Test for Near Infrared Spectrometry <G1-3-161> ..2611. Therapeutic Protein Injections ..194. G2 Solid-state Properties 7. Tests for Containers and Packing Materials Solid and Particle Densities <G2-1-171>..2614. Test for Glass Containers for Injections ..195. Powder Fineness <G2-2-171> ..2615. Test Methods for Plastic Powder Flow <G2-3-171> ..2616. Test for Rubber Closure for Aqueous Measurement of the Diameter of Particles Infusions ..201. Dispersed in Liquid by Dynamic Light 9. Reference Standards; Standard Solutions;. Scattering <G2-4-161> ..2618. Reagents, Test Solutions; Measuring G3 Biotechnological/Biological Products Instruments, Appliances, etc. Basic Concept of the Quality Control on Reference Standards Biotechnological Products Reference Standards ..203. (Biopharmaceuticals) <G3-1-180> ..2621. Standard Solutions Amino Acid Analysis <G3-2-171>.

9 2625. Standard Solutions for Volumetric Peptide Mapping <G3-3-142> ..2632. Analysis ..207. Mass Spectrometry of Peptides and Proteins Standard Solutions ..218. <G3-4-161>..2635. Matching Fluids for Color ..221. Monosaccharide Analysis and Oligosaccharide Reagents, Test Solutions, etc. Analysis/Oligosaccharide Profiling <G3-5-170>. Reagents, Test Solutions ..221..2637. Solid Supports/Column Packings for Isoelectric Focusing <G3-6-142> ..2641. Chromatography ..391. Capillary Electrophoresis <G3-7-180> ..2643. Filter Papers, Filters for filtration, SDS-Polyacrylamide Gel Electrophoresis Test Papers, Crucibles, etc..394. <G3-8-170>..2648. Standard Particles, Host Cell Protein Assay <G3-9-172> ..2653. Measuring Instruments and Appliances, Surface Plasmon Resonance <G3-10-170> ..2656. Thermometers, etc. Enzyme-linked Immunosorbent Assay (ELISA). Optical Filters for Wavelength and <G3-11-171> ..2659. Transmission Rate Calibration ..395. Total Protein Assay <G3-12-172>.

10 2662. Measuring Instruments, Basic Requirements for Viral Safety of Thermometers ..396. Biotechnological/Biological Products listed in Official Monographs ..399 Japanese Pharmacopoeia <G3-13-141> ..2666. Crude Drugs and Related Drugs ..1939 Mycoplasma Testing for Cell Substrates used for the Production of Biotechnological/Biological Infrared Reference Spectra ..2179 2395 Products <G3-14-170> ..2678. JP XVIII Contents Qualification of Animals as Origin of Aerodynamic Particle Size Measurement for Animal-derived Medicinal Products provided Inhalations by Glass Impingers <G6-3-171>. in the General Notices of Japanese ..2741. Pharmacopoeia and Other Standards Tablet Hardness Determinations <G6-4-180>. <G3-15-141> ..2682 ..2743. G4 Microorganisms Tablet Friability Test <G6-5-150> ..2744. Microbial Attributes of Non-sterile pH Test for Gastrointestinal Medicine <G6-6-131>. Pharmaceutical Products <G4-1-170> ..2684 ..2744. Control of Culture Media and Strains of Test for Trace Amounts of Aluminum in Total Microorganisms Used for Microbial Tests Parenteral Nutrition (TPN) Solutions <G4-2-180>.