Pharmeuropa: Revised Chapter 2.2.47. "Capillary electrophoresis" published for Comments
Recommendation

3/4 February 2026
Evaluation, Implementation and Use of Suitable Technologies
In the Pharmeuropa issue 35.3, a proposal for a revised chapter 2.2.47 "Capillary electrophoresis" was published. The deadline for submitting comments is 30 September 2023.
Capillary electrophoresis is defined as a physical technique of analysis based on the migration, inside a capillary, of charged analytes dissolved in an electrolyte solution, under the influence of a direct-current electric field.
According to the briefing notes, compared to the monograph published in the 11th Edition of the Ph. Eur., the following changes are proposed:
- "Apparatus: a description of the two modes of injection, the hydrodynamic injection and the electrokinetic injection, has been added.
- Adjustments of operating conditions: the section has been introduced to list the parameters that may be adjusted to satisfy the system suitability criteria.
- In addition, the chapter has undergone a general review and minor and/or editorial changes have been made throughout the text in order to clarify some parts."
The full text of the proposed revised chapter and further details on the revision and can be found, after registration, on the Pharmeuropa website.
Related GMP News
10.12.2025FDA Warning Letter: 1,500 OOS Results with Numerous Inadequate Investigations
26.11.2025FDA Warning Letter Highlights Deficiencies in SST and HPLC Practices
13.11.2025Proposed Revision of USP <1225> Published in the Pharmacopeial Forum
13.11.2025Recent Publications Highlighting Topics to be Discussed at PharmaLab 2025
12.11.2025USP seeks early Input on new NMR Method


