Quantitation of 5 Nitrosamines in Metformin API and Formulation by HS-GCMS/MS

User Benefits

- A HS-GCMS/MS method for the determination of 5 Nitrosamines in Metformin API & formulation - The GCMS-TQ8040 NX system easily meets the criteria as per the USFDA guidance on Nitrosamines

Introduction

The United States Food and Drug Administration (USFDA) has extensively investigated the presence of genotoxic impurities, called Nitrosamines (NSA) in many Active Pharmaceutical Ingredients (API) & Finished Dosage Formulations (FDF). Several drug products including Angiotensin II Receptor Blockers (ARB) and Ranitidine, have been found to contain small amounts of NSA such as N-nitrosodimethylamine (NDMA). There has been an ongoing investigation to further check the presence of NSA in other drug products as well, such as Metformin. 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 hence, it is imperative to make Metformin drug available with safe levels of NSA.

August 2, 2021 GMT