N-nitrosamine impurities analysis :Ph. Eur. Commission adopts a new general chapter

The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances. The general chapter focuses mainly on the analysis of N-nitrosamine impurities in angiotensin-II-receptor antagonists (sartans) containing a tetrazole group. In order to support the implementation of the general chapter, seven reference standards have been established and are available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).The general chapter will be published in Ph. Eur. Supplement 10.6 in July 2021.

Source:https://www.edqm.eu/en/news/ph-eur-commission-adopts-new-general-chapter-analysis-n-nitrosamine-impurities