Finding the right formula for nitrosamine risk mitigation 

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The pharmaceutical industry is facing many challenges to ensure drug products are free from nitrosamine contaminants and safe for human use. Since the discovery of potentially carcinogenic nitrosamines in some commonly prescribed drug products in 2018, mitigating nitrosamine risk has been a top priority for the pharmaceutical industry and its governing bodies. As such, strict regulations have been implemented by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) to assess and minimize the risk of nitrosamine impurities in existing and new drug formulations. However, navigating the new legislation and choosing a suitable mitigation strategy is a complex process.  

Navigating nitrosamine risk mitigation with confidence

Many research groups are investigating possible root causes of nitrosamine contamination in human drug products and potential mitigation strategies…

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