SinS - Abstract

Abstract Information :

Nitrosamine Impurities have been an issue in the pharmaceutical industry following several high-profile recalls in recent years. This has led to regulatory bodies such as the EMA and FDA requiring manufacturers of pharmaceutical products to undertake risk assessments of their entire product lines for potential nitrosamine content. As these risk assessments have taken place, several potential sources and the nitrosamines that may be derived from them have been identified. Analytical methods to measure these particular nitrosamines have been developed, typically based on high-resolution MS or MSMS systems to achieve the required LOQ. Although undoubtedly useful, this targeted approach for specific nitrosamines has one fundamental flaw. It only allows you to see what you are actively looking for and potentially means other nitrosamines formed from sources not yet considered may be missed. One approach is to use a technique that looks for the nitrosamine functional group rather than a particular compound. This talk will look at how an automated total nitrosamine analysis system can help rapidly screen samples for nitrosamine content regardless of their type to give a result for total nitrosamine content. This approach can speed up the analysis process with only a positive sample needing further speciated testing. It can also catch any potential unknown nitrosamine content giving greater confidence when undertaking a risk assessment.