Revision of USP Chapter <1053> Capillary Electrophoresis Published for Comments
Recommendation

9-11 June 2026
Development, Validation & Control
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
03.06.2026EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026
03.06.2026FDA Warning Letter: Missing Method Validation - From a QC Topic to a Market-Access Problem
28.05.2026WHO Working Document on Bioequivalence open for Public Consultation
21.05.2026LCGC Article on Analytical Procedure Lifecycle Approaches


