Focus on the new general chapter on the analysis of N-nitrosamine impurities in active substances
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 will provide 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 will also include a recap of the Ph. Eur. approach to keeping the monographs aligned with the latest regulatory decisions.
The webinar will take place on 21 January 2021, from 1 p.m. to 2:30 p.m. (Paris, France).
There will also be ample time at the end of the presentations for live questions and answers.
Participation is free of charge.
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.
No special software is necessary for the webinar. If you wish to connect to audio using VoIP (Voice over Internet Protocol) you will need a fast internet connection, a microphone and speakers. A USB headset is recommended. The VoIP connection is free.
You are strongly advised to consult your IT Department to ensure your computer can receive the webinar and that the following domain names are neither rejected nor blocked as spam, otherwise you will not receive the link to connect to the webinar: @gotowebinar.com and @care.gotowebinar.com.