• Add this page to "Favorite pages"
  • Print the text(Open link in a new browser window)
Here begins the text.

JP Technical Information

Information on Japanese Pharmacopoeia

Implementation of ICH-Q3D into Japanese Pharmacopoeia

The information on implementing requiring control of elemental impurities on the basis of ICH-Q3D (GUIDELINE FOR ELEMENTAL IMPURITIES ) into Japanese Pharmacopoeia is posted.

  1. Briefing on Proposed Revision General Test “2.66 Elemental Impurities Procedures” (September 2019)
  2. Handling of Elemental Impurities in Prescription Drugs (PSEHB/PED Notification No. 1228-7, December 28, 2020)
  3. Question and Answer (Q&A) about Handling of Elemental Impurities in Prescription Drugs (Administrative Notice, December 28, 2020)

Related Information on the JP18th edition

  1. Briefing on Proposed Revision General Test “2.66 Elemental Impurities Procedures” (September 2019)
  2. Briefing on Proposed Draft Official Monograph “Eribulin Mesilate” (September 2019)

Information about Columns for Japanese Pharmacopoeia Draft Monographs

  • Columns (Chemical drug / Crude drug)

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

  • Contact us
  • Access/Map

Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved.

000048326
0
JP Technical Information
/english/rs-sb-std/standards-development/jp/0028.html
en