Nitrosamine

USP has launched the newest tool in their suite of solutions to address the evolving nitrosamines crisis: the Nitrosamines Analytical...

The potential for active pharmaceutical intermediates and active ingredients to contain low levels of N-nitrosamines is a topic of continued interest...

Many nitrosamines have been recognized to be carcinogenic for many decades. Despite the fact that several nitrosamine precursors are frequently...

In mid-2018, N-nitroso-dimethylamine (NDMA) was unexpectedly detected in a valsartan active pharmaceutical ingredient (API). NDMA, like many other nitrosamines, is...

The European Medicines Agency, the U.S. Food and Drug Administration, and other regulatory agencies expect that all pharmaceutical products be...

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...