The new harmonised general chapter “Elemental Impurities (G-07)” was signed-off by the Pharmacopoeial Discussion Group (PDG) on 19 June 2024. The PDG brings together the European Pharmacopoeia (Ph. Eur.), Indian Pharmacopoeia Commission (IPC), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP).

The implementation of this harmonised chapter along with the application of the concepts of ICH Q3D Guideline, which includes appropriate limits for specific elemental impurities together with a process for their assessment and control, promote the development of individual monographs with aligned requirements for elemental impurities among the regions of the PDG pharmacopoeias. The PDG started working on a harmonised general chapter for application in their respective regions, with USP as coordinating pharmacopeia in June 2014.

During the development of the harmonised text, the participating pharmacopoeias focused on including the updated requirements described in the ICH Q3D Guideline and also achieved harmonisation on acceptable approaches for analytical procedures. 

To find out more, read the press release "General chapter Elemental Impurities (G-07) harmonised by the Pharmacopoeial Discussion Group".