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

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

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"