Nitrosamine trace impurities belong to a defined nitrosamine chemical grouping within the broader nitrosamine impurity family and can arise as nitrosamine impurity formation products during pharmaceutical manufacturing, processing, or storage. Many of these, including secondary nitrosamine species, are classified as nitrosamine priority substances, nitrosamine restricted compounds, or even nitrosamine unacceptable impurities due to their genotoxic and carcinogenic potential at trace levels. As a result, regulators identify these compounds as key nitrosamine regulatory focus items, issuing nitrosamine impurity warnings and requiring rigorous evaluation of specific nitrosamine analytes through sensitive analytical methods, comprehensive risk assessment, and robust control strategies to ensure product safety and compliance.
Manasa Life Science is a trusted supplier and manufacturer of nitrosamines and N-nitroso compounds, offering high-quality reference standards for research, analytical testing, and regulatory compliance. Our portfolio supports precise detection and quantification of nitrosamine impurities in pharmaceuticals, food, and other matrices, featuring key compounds like NDMA, NDEA, NDPA, and NDBA, with the complete catalog available online.