Quantitation of 6 Nitrosamines in Losartan API by LC-MS/MS system as per the proposed USP General Chapter

User Benefits

- An LC-MS/MS method for the determination of 6 nitrosamines in Losartan API as per the proposed USP general chapter <1469>. - The LCMS-8045 system easily meets the criteria as per the proposed USP general chapter <1469>.

Introduction

The Drug Regulatory Authorities first noticed the presence of the nitrosamine (NSA) impurity, NNitrosodimethylamine (NDMA) in products containing valsartan in July 2018. Valsartan is an Angiotensin II Receptor Blocker (ARB) and belongs to a family of analogue compounds commonly referred to as the Sartans. Further, few other nitrosamines were subsequently detected in other drug substances belonging to the Sartan family, other Active Pharmaceutical Ingredients (API’s), and Finished Pharmaceutical Products (FPP). These included N-nitrosodimethylamine (NDMA), N-nitroso-N-methyl-4- aminobutyric acid (NMBA), N-nitroso-diethylamine (NDEA), N-ethyl-N-nitroso-isopropylamine (NEIPA), N-nitrosodiisopropylamine (NDIPA) and N-nitroso-di-n-butylamine (NDBA).

May 24, 2021 GMT