FDA recommends LC-HRMS to test for NDMA in ranitidine products

European Pharmaceutical Review | October 03, 2019

The US Food and Drug Administration (FDA) has announced an update on its method recommendation of testing for NDMA in ranitidine medication products. The ingredient is a probable human carcinogen. A previous method published by the FDA for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities has been utilised by a third-party laboratory to test ranitidine products. However, this uses high temperatures which results in ranitidine generating NDMA. Therefore, the FDA has recommended using a Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) technique to test samples as this does not use high temperatures. These tests have shown the presence of much lower levels of NDMA in ranitidine products than the third-party laboratory. Other international regulators using a similar LC-MS method have also demonstrated low levels of NDMA in ranitidine samples.

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Is solid form characterization critical in your line of work, but you lack expertise in X-ray diffraction (XRD)? Do you need an efficient tool to support you with lead optimization? Do you need an easy way to validate the stability of your solid form following processing?

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