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

Recommendation

21/22 February 2024
Berlin, Germany

Quality Control of Starting Materials (APIs and Excipients)

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.