Speakers: Tony Edge, Ph.D., Site Director (Product R&D), Avantor Hichrom
Tony Edge
When: Wed, Nov 3, 2021 9:00 AM - 10:00 AM PDT
Event Overview: In the summer of 2018, the pharmaceutical landscape for the manufacture of small molecules has changed forever with the discovery of a genotoxic compound called N-nitrosodimethylamine (NDMA) in a batch of Valsartan manufactured by Zhejiang Huahai Pharmaceutical in China. Valsartan is a prescription only drug to treat high blood pressure and heart failure, which is a selective angiotensin II receptor blocker (ARB) used to dilates blood vessels. In routine analysis, the QC chemists found that there were approaching 60 ppm of NDMA, which is high enough to cause one extra case of cancer in 500 patients. On 5th July of 2018, the European Medical Agency (EMA) gave notice to recall selected batches of Valsartan with immediate effect. Since 2018, NDMA and other nitrosamines have been detected at alerted levels 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 generate these 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 nitrosamines that have been identified as genotoxins by the US Food and Drug Administration (FDA) to monitor, initially showing how to perform a separation of these compounds from the active pharmaceutical ingredient (API) and then looking at how mass spectrometry can be applied to the analysis to ensure that the required detection limits can be reached.
Key learning Objectives:
• Learn the importance of testing for NDMA concentrations in pharmaceuticals
• Understand the regulatory landscape that has evolved to deal with this range of genotoxins such as nitrosamines impurities
• Review examples of nitrosamine analysis