N-nitrosodimethylamine (NDMA) contamination of ranitidine products: A review of recent findings.

Ranitidine is a medication that has been used to alleviate heartburn and other disorders for over 40 years. Following reports of N-nitrosodimethylamine (NDMA) contamination in ranitidine products, there have been many recalls and registration suspensions. Here, we revise the literature information confirming ranitidine association with NDMA.

HS-SPME-GC-MS as an alternative method for NDMA analysis in ranitidine products.

N-nitrosodimethylamine (NDMA) is a carcinogenic contaminant that was accidentally discovered in drugs, such as valsartan and ranitidine, and more recently in metformin. Liquid chromatography tandem mass spectrometry (LC-MS/MS) is the method typically used for the analysis of NDMA in ranitidine. It seems that using gas chromatography (GC) for NDMA analysis is problematic as ranitidine is sensitive to high temperatures.