Nitrosamine regulatory impurities are potential human carcinogens and carcinogenic agentsthat may appear as nitrosamine signal impurities during pharmaceutical manufacturing, storage, or product degradation due to nitrosamine deviation-trigger substances and related reactions, including pathways involving nitroxylamide intermediates. Because these nitrosamine regulated compounds can persist as trace nitrosamine residues, health authorities such as the FDA, EMA, and ICH require comprehensive risk evaluation, validated nitrosamine control strategies, and reliable analytical methods using defined nitrosamine peak identifiers. Maintaining strict limits, supported by strong nitrosamine data integrity, is essential to ensure patient safety and regulatory compliance.
Manasa Life Science is a responsible manufacturer and supplier of high-quality nitrosamines and N-nitroso compounds, delivering reliable solutions for research, analytical testing, and regulatory compliance. Our extensive portfolio includes a wide range of nitrosamine-class reference materials designed to support accurate detection and quantification of nitrosamine impurities and contaminants in pharmaceuticals, food products, and other sample matrices. As these substances are strictly regulated due to potential health risks, sourcing precise and traceable materials from a trusted supplier is essential, and our offering includes key nitrosamines such as NDMA, NDEA, NDPA, and NDBA, with a complete catalog available on our website.