JP Technical Information

Information on Japanese Pharmacopoeia

Related Information on the Supplement II to the JP18^th edition

1. Briefing on General Test and General Information related to Balances (March 2023)

Related Information on the Supplement I to the JP18^th edition

1. Briefing on drafts of General Tests and General Information related to Chromatography (September 2021)
2. Briefing on New draft of General Information “Functionality-related Characteristics of Excipients Relevant to Preparations” 〈G9-1-181〉 (September 2021)

Related Information on the JP18^th 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)

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)
4. Briefing on removing Heavy Metals Test and Individual Metal Impurity Test from Japanese Pharmacopoeia (JP) Official Monographs after transitional period for adopting the Control of Elemental Impurities ends (December 2021)

• Reference :
  • General Notice 34 (March 2020, Report of the final draft) 
  • 2.66 Elemental Impurities (November 2019, Draft for public comments)

Information about Columns for Japanese Pharmacopoeia Draft Monographs

• Columns (Chemical drug / Crude drug)