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Due to maintenance activity, Global web site will not be available from 6AM till 1 PM ET on 24th August 2024

Analysis of Nitrosamines in APIs

Webinar

Thursday, 18th November, 2021
14:00 to 15:00 (IST)

Register now!

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

Presented By:



Tony Edge

Tony Edge is the R&D Manager at Avantor, heading a team of specialist scientists in developing next generation stationary phases for HPLC. He has worked in both manufacturing and also industry, having periods of employment at LGC and also AstraZeneca as well as ThermoFisherScientific and latterly Agilent Technologies. In 2008, he was fortunate enough to be awarded the Desty memorial lecture for his contributions to innovating separation science, and in the same year also won a clinical excellence award from AstraZeneca.