Signal to noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques

Signal-to-noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques (2.2.46)

• 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 chapter2.2.46 has been revised accordingly and will be included in Supplement 11.3 (to be published in July 2023 and implemented on 1 January 2024).

Reference: EDQM News