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

The announcement of the new harmonized chapter "Elemental Impurities (G-07)" can be found in the "Newsroom" section of the EDQM website.