EDQM Publishes new Document on Revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation Techniques
Recommendation
6/7 May 2025
Challenges and Solutions for Packaging / Devices & Single Use Systems
Register now for ECA's GMP Newsletter
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.
The EDQM has now announced the availability of a new document in the Knowledge database. A press release dated 13 October 2022 states that the "document provides a useful and easy reference guide to the main changes made to the general chapter recently published in the 11th Edition of the European Pharmacopoeia (PDG harmonised chapter) versus the 10th Edition version."
The 22-page document has been added as a PDF file under "Additional information". The following points are addressed:
- Definitions
- Peak symmetry
- System sensitivity
- System sensitivity
- System repeatability
- Adjustments of chromatographic conditions (for TLC, LC, and GC)
- Supercritical fluid chromatography
- Quantitation
Please also note that just recently, due to numerous queries received through the EDQM HelpDesk, selected questions and answers have been published. These complement the series of existing FAQs dealing with the European Pharmacopoeia and international harmonization.
Related GMP News
23.04.2025OTC Drug Production Ceased after FDA Warning Letter
23.04.2025EMA publishes Draft of ICH M13B Guideline on Bioequivalence
16.04.2025EMA publishes four new product-specific Bioequivalence Guidance
09.04.2025Missing Tests and Altered Records: FDA Warns Chinese OTC Manufacturer
09.04.2025Pharmeuropa: New Chapter on Evaporative Light-Scattering Detection published for Comment
09.04.2025Pharmeuropa: Four Draft Chapters on Elemental Analysis Published for Comment