Supplement II to the Japanese Pharmacopoeia Eighteenth Edition - English Version - Ministerial Notification No. 238 - June 28, 2024

Oct 3, 2026

Uploaded by Oliver

Supplement II to the Japanese Pharmacopoeia, Eighteenth Edition, provides an English translation intended for users unfamiliar with Japanese, with the Japanese original treated as authoritative in case of discrepancies. It announces the revision of parts of the Pharmacopoeia under the Minister of Health, Labour and Welfare’s notification dated June 28, 2024. The supplement includes supplementary provisions on effective dates and transitional measures, specifying how standards for drugs in prior or new editions may be accepted until defined deadlines. It also lists contents across general tests and reference spectra.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages173

Reading Time7 h 16 min

AccessFree to download

Preface

Supplement II to The Japanese Pharmacopoeia, Eighteenth Edition

General Tests, Processes and Apparatus

Official Monographs

Crude Drugs and Related Drugs

Infrared Reference Spectra

Ultraviolet-visible Reference Spectra

General Information G1 Physics and Chemistry

G2 Solid-state Properties

G3 Biotechnological/Biological Products

G5 Crude Drugs

SUPPLEMENT II TO THE JAPANESE PHARMACOPOEIA EIGHTEENTH EDITION O‹cial from June 28, 2024 English Version THE MINISTRY OF HEALTH, LABOUR AND WELFARE Notice: This English Version of the Japanese Pharmacopoeia is published for the convenience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic. Printed in Japan The Ministry of Health, Labour and Welfare Ministerial Notification No. 238 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), we hereby revise a part of the Japanese Pharmacopoeia (Ministerial Notification No. 220, 2021) as follows* . TAKEMI Keizo The Minister of Health, Labour and Welfare June 28, 2024 Japanese Pharmacopoeia (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, and made public by publishing it on the website of the Ministry of Health, Labour and Welfare.) 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'') [limited to those listed in the Japanese Pharmacopoeia whose standards are changed in accordance with this notification (hereinafter referred to as ``new Pharmacopoeia'')] and drugs which have been approved as of the notification date 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 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 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 December 31, 2025 . Article 3 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 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, 2025 . Article 4 In the case of drugs which are listed in the new Pharmacopoeia, the previous provisions are applied before and on June 30, 2027, regardless of the Article 2.66 Elemental Impurities of General Tests, Processes and Apparatus in the new Pharmacopoeia . *The term ``as follows'' here indicates the content of Supplement II to the Japanese Pharmacopoeia Eighteenth Edition from General Tests, Processes and Apparatus to Ultraviolet-visible Reference Spectra (pp. 2991 – 3074) . CONTENTS Preface ...................................................... i Supplement II to The Japanese Pharmacopoeia, Eighteenth Edition ........................... 2991–3074 General Tests, Processes and Apparatus ... 2991 2.03 Thin-layer Chromatography ............ 2991 2.46 Residual Solvents .......................... 2992 2.66 Elemental Impurities ...................... 3000 3.01 Determination of Bulk Density ........ 3004 3.

FAQs

What is the purpose of this English version of the Japanese Pharmacopoeia?

It is published for the convenience of users unfamiliar with Japanese. If any discrepancy exists between the Japanese original and the English translation, the Japanese original is authentic.

When does the notification take effect?

The notification is applied from the date of the notification, referred to as the “notification date” in the following articles.

What transitional measures are provided for drug standards during the changeover?

For specified drugs listed in the prior Pharmacopoeia and for drugs approved as of the notification date, name and standards from the prior Pharmacopoeia may be accepted to conform to the new Pharmacopoeia before and on December 31, 2025. Additional provisions specify how previous provisions apply in certain areas until June 30, 2027.

Oct 3, 2026

Uploaded by Oliver