Scientific Poster , Bioanalysis

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


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.