Nitrosamine

Since late 2019, concerns regarding trace levels of the probable human carcinogen N-dimethylnitrosamine (NDMA) in Metformin-containing pharmaceuticals have been an issue if...

INTRODUCTION The effects of N-nitroso compounds on human health (particularly their role in gastric cancer) are well known.1 Certain N-nitrosamines...

This article reports the outcome of an in silico analysis of more than 12,000 small molecule drugs and drug impurities, identifying the...

The recent focus of pharmaceutical regulatory authorities has been oriented towards the mitigation of carcinogenic N-nitrosamines in drug products and different...

The discovery of carcinogenic nitrosamine impurities above the safe limits in pharmaceuticals has led to an urgent need to develop...

In recent years, nitrosamines have been discovered in some types of drug products that becomes a current regulatory hotspot, and...

Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has...

Nitrosamine risk mitigation is front of mind for many drug formulators following the discovery of N-nitrosodimethylamine (NDMA) in valsartan –...