Presenter: Tony Edge, Site Director (Production & R&D), Avantor


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 series of nitrosamines that have been identified by the FDA as genotoxins to monitor, initially showing how to perform a separation of these compounds from the API and then looking at how mass spectrometry can be applied to the analysis to ensure that the required detection limits can be reached.

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