JP Technical Information

Information on Japanese Pharmacopoeia

Related Information on the JP19^th edition

1. A reference for procedures for preparing solutions in the novel monograph "Dapagliflozin Propylene Glycolate Hydrate" [101KB] and a reference for procedures for preparing solutions in the novel monograph "Dapagliflozin Propylene Glycolate Tablets" [173KB] (September 2024)
    (Note) The description of each of novel monographs "Dapagliflozin Propylene Glycolate Hydrate" [162KB] and "Dapagliflozin Propylene Glycolate Tablets" [193KB] differs from the description required in the Guideline for Drafting Monographs for The Japanese Pharmacopoeia, Nineteenth Edition (Partial revision) in that the final concentration of a solution is indicated in the procedure for preparing the solution. To be used as references for preparation of solutions, the preparation procedures of the solutions in accordance with the ordinary descriptions of the Japanese Pharmacopoeia describing specific weighing amounts are provided. The preparation procedure of solutions describing specific weighing amounts are provided as a reference and has been verified by the manufacturer who prepared the drafts. Please note that these procedures are not monographs listed in the Japanese Pharmacopoeia.
2. About the general information (draft) “How to apply the Japanese Pharmacopoeia according to the purpose”[92.6KB] (September 2024)

 

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

1. Briefing on General Test and General Information related to Balances [98.1KB] (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 [580KB] (September 2021)
2. Briefing on New draft of General Information “Functionality-related Characteristics of Excipients Relevant to Preparations” 〈G9-1-181〉[306KB] (September 2021)

 

Related Information on the JP18^th edition

1. Briefing on Proposed Revision General Test “2.66 Elemental Impurities Procedures” [44.9KB] (September 2019)
2. Briefing on Proposed Draft Official Monograph “Eribulin Mesilate” [37.5KB] (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” [44.9KB] (September 2019)
2. Handling of Elemental Impurities in Prescription Drugs [178KB] (PSEHB/PED Notification No. 1228-7, December 28, 2020)
3. Question and Answer (Q&A) about Handling of Elemental Impurities in Prescription Drugs [345KB] (Administrative Notice, December 28, 2020)

Note:
This administrative notice is abolished in association with the issuance of the Administrative Notice “Question and Answer (Q&A) about Handling of Elemental Impurities” issued by the Pharmaceutical Evaluation Division of the Pharmaceutical Safety Bureau, MHLW (June 25, 2024).

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 [117KB] (December 2021)
5. Handling of Elemental Impurities in Behind-the-counter/Over-the-counter Drugs [83.9KB] (PSEHB/PED Notification No. 1212-5, December 12, 2022)
6. Question and Answer (Q&A) about Handling of Elemental Impurities [186KB] (Administrative Notice, June 25, 2024)

• Reference :
  • General Notice 34 [119KB] 
  • 2.66 Elemental Impurities [163KB] 

 

Information about Columns for Japanese Pharmacopoeia Draft Monographs

• Columns (Chemical drug / Crude drug)