EDQM: General Chapter „Elemental Impurities (G-07)“ Harmonised

29.11.2024

News

The Pharmacopoeial Discussion Group (PDG) signed off on the harmonised general chapter “Elemental Impurities (G-07)” on 19 June 2024. The PDG, which includes the European Pharmacopoeia (Ph. Eur.), Indian Pharmacopoeia Commission (IPC), Japanese Pharmacopoeia (JP), and United States Pharmacopeia (USP), worked on this chapter to align elemental impurity requirements across regions based on the ICH Q3D Guideline.

The PDG focused on including the updated requirements described in the ICH Q3D Guideline and also achieved harmonisation on acceptable approaches for analytical procedures, specifically on the following topics:

Sample preparation
Examples of applicable procedures and detection techniques
Requirements for procedure validation

The regional texts are expected to be published in July 2025 (Ph. Eur.), December 2025 (USP), April 2026 (JP) and July 2026 (IPC). This milestone marks the PDG’s successful harmonisation of all the general chapters on ist work programme and 48 of the 62 excipient monographs listed.

Source:

EDQM: Newsroom

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