Quantitation of 7 Nitrosamines in API by HSGC-MS/MS as per proposed USP General Chapter


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・A HSGC-MS/MS method for the determination of 7 nitrosamines in Losartan API as per the proposed USP general chapter<1469> ・The GCMS-TQ8050 NX system easily meets the criteria as per the proposed USP chapter <1469> procedure-2


The Drug Regulatory Authorities first noticed the presence of nitrosamine impurity (NSA), N- Nitrosodimethylamine (NDMA) in products containing valsartan in July 2018. Valsartan is an Angiotensin Ⅱ Receptor Blocker (ARB) and belongs to a family of analog compounds commonly referred to as the Sartans. Further, a few other nitrosamines were subsequently detected in other drug substances belonging to the Sartan family & other Active Pharmaceutical Ingredients (API’S) & Finished Pharmaceutical Products (FPP) including: N-Nitrosodiethylamine (NDEA), Nitrosodiisopropylamine (NDIPA) Nitrosoethylisopropylamine (NEIPA) N-Nitrosodibutylamine (NDBA), N-Nitrosodi-n-propylamine(NDPA) & N-Nitroso-N’-methylpiperazin (NMPrZ). What are Nitrosamines?: Nitrosamines refer to any molecule containing the nitroso functional group. Although they are also present in some foods and drinking water supplies, their presence in drugs is considered unacceptable. Occurrence: Formation of nitrosamines is possible in the presence of secondary, tertiary, or quaternary amines and nitrite salts under acidic reaction conditions. Under these conditions, nitrite salts may form nitrous acid, which can react with an amine to form a nitrosamine. Apart from there, these are other routes such as, vendor-sourced starting materials and raw materials, Recovered Solvents, Catalysts and Reagents, cross-contamination from the common manufacturing facility, and Quenching Process using Nitrous acid & packing/storage may result in Nitrosamine formation or contamination.

August 1, 2021 GMT