Information on Japanese Pharmacopoeia
Related Information on the Supplement II to the JP18th edition
Related Information on the Supplement I to the JP18th edition
- Briefing on drafts of General Tests and General Information related to Chromatography (September 2021)
- Briefing on New draft of General Information “Functionality-related Characteristics of Excipients Relevant to Preparations” 〈G9-1-181〉 (September 2021)
Related Information on the JP18th edition
- Briefing on Proposed Revision General Test “2.66 Elemental Impurities Procedures” (September 2019)
- 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.
- Briefing on Proposed Revision General Test “2.66 Elemental Impurities Procedures” (September 2019)
- Handling of Elemental Impurities in Prescription Drugs (PSEHB/PED Notification No. 1228-7, December 28, 2020)
- Question and Answer (Q&A) about Handling of Elemental Impurities in Prescription Drugs (Administrative Notice, December 28, 2020)
- 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)