Revision to Appendix III, Chromatographic Separation Techniques

A revision to Appendix III, Chromatographic Separation Techniques, of the British Pharmacopoeia (BP) was published in the in-year update to the online version of the BP 2023 (Ph. Eur. 11.0 update). The revision reproduced general chapter 2.2.46 of the European Pharmacopoeia in the BP, which includes many important changes and becomes effective on the 1^st January 2023.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) have announced that they are advising users that the sensitivity requirement used in calculation of the signal-to-noise (S/N) ratio in the revised general chapter should not be implemented.

https://www.edqm.eu/en/-/signal-to-noise-ratio-revision-of-ph.-eur.-general-chapter-chromatographic-separation-techniques-2.2.46-

General chapter 2.2.46 has been revised and will be included in Supplement 11.3 (to be published in July 2023 and implemented on 1 January 2024). The revised chapter will be reproduced in the BP at the earliest possible opportunity.