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Controlling a cohort - Understanding the risk of nitrosamines within drug substance synthesis (Webinar Presentation Slides)

Burns MJ;

In this presentation, Dr. Michael Burns, Senior Scientist at Lhasa presented on the topic of "Understanding the risk of nitrosamines in drug substance synthesis".

Risk assessments for nitrosamines within marketed drugs must be completed by October 2020, generating a significant challenge for the pharmaceutical industry. Identifying conditions which are favourable to nitrosamines formation represents a key area of knowledge for the pharmaceutical industry and regulatory bodies alike. The use of purge arguments, utilising the scientific understanding of process chemists involved in their manufacture presents a valuable tool to enable a rapid evaluation of risk within drug syntheses. Understanding the potential and limitations for purge of nitrosamines through reactivity constitutes a significant element of potential purge, and was also discussed within this presentation. 


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