Revision of USP Chapter <1053> Capillary Electrophoresis Published for Comments
Recommendation
Monday, 29 September 2025 14.00 - 17.00 h
Register now for ECA's GMP Newsletter
In the Pharmacopeial Forum, PF 50(1), a new version of USP Chapter <1053> Capillary Electrophoresis was published. The proposal is based on the version of the chapter official as of 01 August 2020.
According to the briefing notes, the following changes were made:
- "Add Hydrodynamic Injection and Electrokinetic Injection in the Apparatus section to elaborate these two injection modes.
- Add a new section for Adjustments of Operating Conditions for Capillary Electrophoresis.
- Reformat equations, improve wording, and conform to international terms throughout."
The reason for the changes is the harmonization with the corresponding chapter in the Japanese Pharmacopoeia and European Pharmacopoeia (please see our news archive for further information).
The draft of the revised USP chapter is available on PF Online. Comments can be submitted until 31 March 2024.
Related GMP News
27.08.2025FDA Warning Letter: Missing Identity Tests, Unverified CoAs, and Inadequate DEG/EG Controls
20.08.2025USP Responds to Comments on Chapter <202> HPTLC Identification of Fixed Oils
13.08.2025USP publishes Comments rereived on Chapter <317>
13.08.2025FDA Issues Warning Letter to Contract Testing Laboratory for Inadequate OOS Investigations
06.08.2025EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence
06.08.2025FDA Warning Letter: Company Voluntarily Ceases Drug Production