The discovery in 2018 of nitrosamines contamination in blood pressure medicines has triggered a wide-scale product recall and regulatory review which has set stringent portfolio risk assessment requirements for the pharmaceutical industry. Regulatory organisations worldwide are operating a zero-risk environment which poses an extremely challenging target for all the laboratories involved in the analysis of nitrosamines in active pharmaceutical ingredients and drug products. In fact, whilst analysis of nitrosamines in solvent standards can achieve the very low limits of detection established by the regulations, it is the investigation of nitrosamines levels in the real samples which poses the hardest challenge to the analytical community. Sample preparation is a crucial part of any analytical workflow and its optimisation and control are essential in driving high quality data. Automation of sample preparation can help significantly in addressing some of the many challenges to be faced in the analysis of nitrosamines thanks to its inherent qualities: convenience, control, and consistency. This application note will outline the approach taken by Anatune in tackling the nitrosamine challenge harnessing the power of automation.
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Nitrosamines in API and Drug Products