Nitroso-group impurities, often encountered as nitrosamine residual impurities, are characterized by the presence of a nitroso (–N=O) functional group and may form unintentionally during synthesis, processing, or storage of pharmaceutical and chemical products. Due to their potential genotoxic and carcinogenic nature, stringent nitrosamine safety assessments are required, supported by advanced nitrosamine research techniques, validated nitrosamine extraction methods, and the use of qualified nitrosamine CRMs. Regulatory expectations emphasize comprehensive nitrosamine impurity profiling, robust nitrosamine testing protocols, and ongoing nitrosamine stability testing, along with defined nitrosamine corrective actions and clear nitrosamine reporting obligations to ensure product quality, patient safety, and regulatory compliance.
Manasa Life Science is a reliable producer and supplier of nitrosamines and N-nitroso compounds, providing dependable reference standards for research, analytical testing, and regulatory compliance. Our range enables precise identification and measurement of nitrosamine impurities in pharmaceuticals, food products, and other matrices, including essential compounds such as NDMA, NDEA, NDPA, and NDBA, with a complete product list available on our website.