Elemental Impurities: Harmonized chapter finalized

In late November 2024, it was reported on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) that the new harmonized chapter "Elemental Impurities (G-07)" of the "Pharmacopoeial Discussion Group (PDG)" had been signed in June 2024. The PDG consists of representatives from the European Pharmacopoeia (Ph. Eur.), the Indian Pharmacopoeia Commission (IPC), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP).

In particular, the harmonization focused on the implementation of the updated requirements of the ICH Q3D guideline and the harmonization of analytical procedures. Special focus was placed on the following three points:

Sample preparation
Examples of suitable methods and detection techniques
Requirements for the validation of procedures
The new harmonized chapter "Elemental Impurities (G-07)" will be published in the regional pharmacopoeias according to the following timelines:

Ph. Eur: July 2025
USP: December 2025
JP: April 2026
IPC: July 2026

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