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JP Technical Information

Information on Japanese Pharmacopoeia

Related Information on the Supplement I to the JP18th 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 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)

 

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)

 

Information about Columns for Japanese Pharmacopoeia Draft Monographs

  • Columns (Chemical drug / Crude drug)

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JP Technical Information
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