The revised general chapter Chromatographic separation techniques (2.2.46) was published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.) in the framework of international harmonisation. This new version (due to be implemented on 1 January 2023) includes many important changes.
One of these changes is the sensitivity requirement. The revised chapter instructs users to calculate the signal-to-noise (S/N) ratio on a window of 20 times the peak width at half height (“20 x Wh”), whereas from Ph. Eur. Supplement 6.4 through Supplement 10.8, it is calculated on a window of at least 5 times the peak width at half height (“at least 5 x Wh”).
Recent data gathered by the European Directorate for the Quality of Medicines & HealthCare (EDQM) showed that this change might be technically challenging for a number of our users, prompting the Ph. Eur. Commission to reconsider it.
As a result, Ph. Eur. users are advised to continue calculating the S/N ratio on a window “at least 5 x Wh”, instead of “20 x Wh”.
General chapter 2.2.46 has been revised accordingly and will be included in Supplement 11.3 (to be published in July 2023 and implemented on 1 January 2024).