The nitrosamine supply chain involves the sourcing, manufacturing, handling, and distribution of nitrosatable substances and related impurities, categorized under nitrosamine quality terminology and nitrosamine reference category terms, for use in pharmaceuticals, research, and analytical testing. Due to the potential risks posed by nitrosamine sensitive impurities and their inclusion in nitrosamine contamination categories, every stage from raw material procurement to final delivery requires strict oversight and traceability. Management of nitrosamine extraction targets, nitrosamine testable compounds, nitrosamine detection class, and nitrosamine quantitation compounds ensures safe, consistent, and reliable materials. Supported by nitrosamine global distributors, this approach minimizes exposure risks while maintaining compliance with regulatory standards worldwide.
Manasa Life Sciences is a leading manufacturer and supplier of N-nitrosamine impurities, offering high-quality reference standards for the pharmaceutical industry. The company provides nitrosamine byproducts and manufacturing-related impurities with complete regulatory documentation, ensuring high purity, accurate characterization, and compliance with USFDA and global guidelines. Its portfolio includes NDMA, NDEA, NDPA, NDBA, and other standards, supporting analytical testing, method validation, and nitrosamine risk assessment across pharmaceuticals, APIs, and other products worldwide.