Analysis of Nitrosamines in APIs

Since 2018, NDMA and other nitrosamines have been observed in a range of different pharmaceuticals. This webinar will look at the chronological development of the story and how nitrosamines have caused the pharmaceutical industry to re-evaluate their manufacturing procedures. It will look at the synthetic pathways that can cause the generation of this range of genotoxins and the regulatory landscape that has evolved as a consequence of the initial findings. We will then discuss the development of a series of applications that will allow for the determination of a range of nitrosamines that have been identified by the FDA as genotoxins to monitor.

Key Points Covered: 

• Complex and continually evolving needs of nitrosamines analysis
• Detailed risk assessment - Analysis to identify and mitigate
• Highly sensitive solution to quantitation at the very low levels for mutagenic impurities.

The webinar will finish with a short Q&A session. For more information, please contact us at amea.webinars@avantorsciences.com