EBF 2021: Analysis of Ranitidine Reference Materials Using a Six N-Nitrosamine LC-MS/MS Assay

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We built an assay to determine six pharmaceutically relevant N-Nitrosamines in both drug substances and drug products. The analytes included in our assay were N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine(NDEA), N-Nitroso-N-Methylaniline(NMPA), N-Nitrosodiisopropylamine(NDIPA), N-Ethyl-N-Nitroso-2-Propanamine(NIPEA) and N-Nitrosodi-n-Propylamine(NDPA). We applied our assay to determine N-nitrosamines in three different Ranitidine Reference Materials: Ranitidine Hydrochloride British Pharmacopoeia Chemical Reference Substance (BPCRS), Ranitidine Hydrochloride European Pharmacopoeia (EP) Reference Standard and Ranitidine Hydrochloride United States Pharmacopeia (USP) Reference Standard.