Saikat Banerjee is application and business manager for LCMS with Agilent Technologies, Inc.
Development of a Validated Method of Testing for NDMA in Ranitidine
October 3rd 2020This article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.