EDQM publishes FAQs on revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation Techniques

Recommendation
Monday, 29 September 2025 14.00 - 17.00 h
A revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023.
Due to numerous queries received through the EDQM HelpDesk, selected questions and answers have now been published. These complement the series of existing FAQs dealing with the European Pharmacopoeia and international harmonization. According to the EDQM, "this is expected to enhance customer support and facilitate user understanding."
New FAQs
The new FAQs address the following four topics:
- System sensitivity and S/N ratio
- Peak symmetry
- Implementation of the new requirements for existing monographs
- Implementation of the new requirements for in-house procedures
Further information
The new FAQs can be found on the EDQM website in the EDQM FAQs section.
For more information, please see the following announcements:
- Announcement of 08 September 2022: : "New FAQ on EDQM HelpDesk: Ph. Eur. revised general chapter 2.2.46. Chromatographic separation techniques"
- Announcement of 27 July 2022: "General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition"
Related GMP News
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
23.07.2025New HPTLC Chapter Proposed for The International Pharmacopoeia