During its 168th Session, the European Pharmacopoeia Commission adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42, previously listed as 2.4.36). The new general chapter proposes three procedures and focuses mainly on the analysis of N-nitrosamine impurities in angiotensin-II-receptor antagonists (sartans) containing a tetrazole group, for which there are five Ph. Eur. monographs (valsartan, losartan potassium, candesartan cilexetil, irbesartan and olmesartan medoxomil), but may also be helpful to establish a control strategy for other active substances or for medicinal products.
This webinar provides users and stakeholders with an update on the different activities related to N-nitrosamine impurities, including a detailed overview of the new general chapter. It also includes a recap of the Ph. Eur. approach to keeping the monographs aligned with the latest regulatory decisions.
Topics include:
- Control of genotoxic impurities in the Ph. Eur. : focus on nitrosamines
- The regulatory decisions and their impact on the Ph. Eur.
- Overview of the new Ph. Eur. general chapter on control of N-nitrosamines in active substances
- An update on N-nitrosamines and CEPs
Duration: 1 hour, 30 minutes.
Target audience
This webinar is of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in the regulatory affairs area.
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