Trace Level Quantitation of 6 Nitrosamines in Metformin API by Dynamic Headspace GC-MS/MS

User Benefits

- Dynamic headspace equipped with GC-MS/MS was used for trace level quantitation of Nitrosamines in Metformin API - GCMS-TQ8050 NX system equipped with HS-20 easily meets the criteria as per the regulatory guidelines on Nitrosamines - Compared to static headspace, dynamic headspace has advantage in trace level detection of Nitrosamines

Introduction

Regulatory bodies related to pharmaceutical industry had extensively investigated the presence of genotoxic impurities, called Nitrosamines (NSA), in many drugs. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. Patients should continue taking Metformin to keep their diabetes under control and hence it is imperative to make Metformin drug available with safe levels of NSA.

August 2, 2021 GMT