Abstract

NITROSAMINE IMPURITIES IN PHARMACUTICAL

Miss. Janvi Rajeshwar Umap*, Associate Prof. Ruchika Gawande, Dr. Rahul Bijwar

ABSTRACT

N-Nitrosamines (Or Nitrosamines) Are Probable Or Possible Human Carcinogens To Which Can Be Exposed From Several Known Sources, Such As Food, Drinking Water, Tobacco Smoke And Cosmetic Products. However, Until Mid-2018 Their Presence In Medicinal Products Was Unexpected. These Impurities Were First Detected In The Valsartan Active Pharmaceutical Ingredient (API) And Subsequently Other Sartan Medicines Were Also 3implicated. Meanwhile, These Impurities Have Also Been Detected In A Few Non-Sartan Apis And/Or Medicinal Products. The Presence Of N-Nitroso Compounds, Particularly N-Nitrosamines, In Pharmaceutical Products Has Raised Global Safety Concerns Due To Their Significant Genotoxic And Mutagenic Effects. The Regulatory Response To The Nitrosamines Issue Included A Request To All Marketing Authorization Holders (Mahs) For Human Medicinal Products Containing Chemically Synthesised Active Pharmaceutical Ingredients To Evaluate The Risk Of Nitrosamines Being Present In Their Products And To Take Appropriate Risk Mitigation Measures.

Keywords: Nitrosamine Impurities, Mutagenicity, Carcinogenicity.