Quantitation of 6 Nitrosamines in 5 Sartans by LC-MS/MS system as per the proposed USP General Chapter

User Benefits

- An LCMS method for the determination of 6 nitrosamines in 5 Sartans 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, N-Nitrosodimethylamine (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, a 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-nitroso-dimethylamine (NDMA), N-nitroso-N-methyl-4-aminobutyric acid (NMBA), N-nitrosodiethylamine (NDEA), N-ethyl-N-nitroso-isopropylamine (NEIPA), N-nitroso-diisopropylamine (NDIPA) and N-nitroso-di-n-butylamine (NDBA).

May 19, 2021 GMT