Nitrosamine impurity analysis with LC-MS/MS: Dr Anoop Kumar, Head, Market Development and Marketing, SCIEX

Dr Anoop Kumar, Head, Market Development and Marketing, SCIEX, began his presentation by sharing a brief about his company with the audience. He informed that SCIEX portfolio includes high-performace mass spectrometry, liquid chromatography, ion sources, integrated LC-MS/MS, capillary electrophoresis and powerful software.

He also spoke about the various aspects of nitrosamine that refer to any molecule containing the nitroso functional group bonded to a deprotonated amine. Further, these molecules are of concern because of probable carcinogenic nature in humans, even though there are reports of its presence in some foods and drinking water supplies. However, their presence in medicines is considered unacceptable, he lamented. Speaking further, he said that in 2018, nitrosamines were found in a number of angiotensin II receptor blockers (blood pressure medications) known as ‘sartans.’ Since then, nitrosamine impurity has been detected in a few batches of sartans and ranitidine. In addition to it, he said that the worldwide review of various sartans and ranitidine products has been initiated. This has led to various recalls of several products from the US and the EU markets.

Regulators have now strict manufacturing requirements for these medicines, he noted.

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines require screening limits of 26.5 ng/day or 96 ng/day, depending in the nitrosamine. In February 2021, the European Pharmacopoeia Commission published a new chapter 2.5.42 that proposes new procedures for the analysis of N-nitrosamines in active substances. The new chapter focusses on five monographs: valsartan, losartan potassium, candesartan cilexetil, irbersartan and olmesartan medoxomil, he noted.