General Chapter Elemental Impurities (G-07) Harmonised By The ICH Pharmacopoeial Discussion Group (PDG)
- Category
EU Regulations, US Regulations, Japanese Regulations, Indian Regulations
- Description
A 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 corresponding regional texts for the harmonised general chapter “Elemental Impurities” are scheduled for publication in July 2025 (Ph. Eur.), December 2025 (USP), April 2026 (JP) and July 2026 (Indian Ph.).