eng Oriental Scientific Publishing Company Biomedical and Pharmacology Journal 0974-6242 2025-12-30 18 4 2635 2652 10.13005/bpj/3282 68261 article Deepali Maruti Jagdale 1 Vineeta Vivek Khanvilkar 1 Abhay Ramchandra Shirode 1 Ammara Hashmat Sahibole 2 Gayatri Shrikant Vinchurkar 2 Department of Pharmaceutical Chemistry, Bharati Vidyapeeth’s College of Pharmacy, University of Mumbai, Navi Mumbai, Maharashtra, India Department of Quality Assurance, Bharati Vidyapeeth’s College of Pharmacy, University of Mumbai, Navi Mumbai, Maharashtra, India Nitrosamine impurities, composed of nitroso and amine functional groups, pose significant carcinogenic and mutagenic risks. An extensive literature survey was undertaken, encompassing peer-reviewed research articles, regulatory authority guidelines, and market recall data, to thoroughly explore the occurrence, sources, and regulatory perspectives related to nitrosamine impurities. The survey revealed that the formation of nitrosamine impurities in active drugs is attributed to factors like reactants and process parameters used in their synthesis and their generation in the drug products can be associated with the active drugs, excipients used, packaging material employed during manufacture and the storage conditions maintained. Stringent regulatory requirement for control of nitrosamine impurities to trace levels in pharmaceuticals necessitates the requirement of highly sensitive advanced analytical techniques for the accurate and precise detection and quantitation of nitrosamine impurities. This review is an elaborative account of the Nitrosamine impurities which gives information related to types of nitrosamine impurities, their toxicological concerns, chemistry behind their formation, and major contributors in their formation along with analytical methods used for their detection with appropriate examples wherever possible. https://biomedpharmajournal.org/vol18no4/nitrosamine-impurities-in-pharmaceuticals-chemistry-toxicology-and-advanced-analytical-approaches/ Analytical techniques Mutagenic impurities Nitrite Nitrosamine impurities Secondary amine