Application Note

NDMA in ranitidine drug substance by QSight™ UHPLC-MS/MS


N-nitroso dimethylamine (NDMA) is one of nitrosamine class impurities classified as a probable human carcinogen (a substance that could cause cancer). NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. The European Medicines Agency (EMA) and theUS Food and Drug Administration (US FDA) have been investigating NDMA and similar nitrosamines compounds since 2018 when they were found in a number of angiotensin II receptor blockers (ARBs), blood pressure medicines known as ‘sartans’, leading to some recalls.