N-Nitrosamines are a class of chemical compounds characterized by the presence of an N–NO (nitroso) functional group attached to a nitrogen atom, typically originating from amines. They are widely recognized in pharmaceutical, environmental, and food safety contexts because certain N-nitrosamines have the potential to be genotoxic, meaning they may interact with DNA and pose safety concerns at elevated levels. In the pharmaceutical industry, N-nitrosamines are monitored as nitrosamine impurities, which can form unintentionally during drug manufacturing, storage, or through reactions involving trace nitrite sources. Regulatory authorities such as the FDA, EMA, and ICH require manufacturers to assess, control, and limit the presence of N-nitrosamines to ensure product safety.
At Manasa Life Sciences, we offer comprehensive scientific and regulatory support for identifying and controlling N-nitrosamines, including nitrosamine impurities, nitrosamine derivatives, nitroso-containing molecules, and nitrosamine by-products that may arise during pharmaceutical development. Our expertise covers emerging areas such as nitrosamine mutagenic impurities and Nitrosamine Drug Substance-Related Impurities (NDSRI), ensuring that partners meet global requirements for nitrosamine impurity limits and regulatory expectations for nitrosamine-class chemicals.
Several nitrosamines have been studied extensively for their toxicological potential, including N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-nitroso-N-methyl-4-aminobutyric acid (NMBA), N-nitrosodiethanolamine (NDELA), nitrosomorpholine (NMOR), N-nitroso-N-methyl-N-ethylamine, and N-nitrosopyrrolidone (NPYR). These evaluations reinforce the importance of continuous monitoring and strong impurity-control strategies across various therapeutic classes. Historical regulatory reviews of products such as sartans and ranitidine further highlight the need for robust risk assessments and ongoing quality surveillance.
With strong technical capabilities and a deep understanding of the pharmaceutical supply landscape, Manasa Life Sciences assists companies in evaluating nitrosamine supply chain susceptibilities, implementing appropriate nitrosamine classification strategies, and adopting the latest nitrosamine standards required for compliance. Our dedicated analytical services include nitrosamine stability testing, assessment of nitrosamine manufacturing by-products, and access to trusted nitrosamine standards suppliers, supporting the growing nitrosamine industry demand and helping manufacturers maintain product quality, safety, and regulatory readiness. We verify nitrosamines using USP standards, and we follow FDA-listed nitrosamines to ensure full regulatory compliance
In addition to our analytical and regulatory expertise, Manasa Life Sciences provides high-quality pharmaceutical manufacturing services, ensuring that every stage of raw material evaluation to final product release is guided by strict quality systems and impurity-control frameworks. Our manufacturing operations prioritize compliance, traceability, and process integrity, enabling clients to meet global regulatory expectations while delivering safe and reliable pharmaceutical products.
