Struggling to confidently detect and quantify Mutagenic Impurities in APIs and Drug Products?

Mutagenic impurities in APIs and drug products pose a significant risk to health and safety—even in small quantities—and thus are a major concern for drug makers. Mutagenic impurities can damage DNA, leading to mutations and potentially cancer. Nitrosamines are formed by chemical reactions that occur during API manufacturing whether from starting materials, intermediates, reactants, reuse of solvents and by-products; they can form through degradation products generated during formulation or storage or from environmental contaminants. Regulatory agencies advise companies on steps to take to avoid nitrosamines in medicines.

Detection and quantification of these trace nitrosamines in APIs and drug products can be challenging and requires the use of advanced and sensitive tools to meet the required regulatory requirements. Agilent offers reliable systems and solutions that not only fulfill FDA directives, but also meet and exceed FDA’s established regulatory requirements to help pharmaceutical customers identify and quantify trace(ppb)nitrosamine and other mutagenic impurities confidently.

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Download Nitrosamine Application Guide