Nitrosoamine Related Standards available for Research Projects.
Medicine Regulatory Authorities first became aware of the presence of the nitrosamine impurity, Nnitrosodimethylamine (NDMA), in products containing valsartan in July 2018. These molecules are of concern because nitrosamine, are classified as probable carcinogens by International Agency for Research on Cancer. Further nitrosamine impurities were subsequently detected in other medicines belonging to the sartan family, including: N-nitrosodiethylamine (NDEA), N -nitrosodiisopropylamine (NDIPA), N -nitrosoethylisopropylamine (NEIPA) and N -nitroso-N-methyl-4-aminobutyric acid (NMBA). Valsartan, Candesartan Cilexetil, Irbesartan, Olmesartan medoxomil, Losartan potassium, Ranitidine, Nizatidine, Metformin can have nitrosoamine as potential impurities.
SynZeal offers extensive range of nitrosoamine related impurities standards with certified COA and characterization data like IR, Mass, HPLC/GC, purity, NMR & TGA report. We also provide CMR, DEPT and detailed structure characterization report as per requirements. Nitrosoamine related standards are being used by major pharmaceutical companies across the globe for their ANDA/DMF filing.
