The EMA has been requesting for the testing of angiotensin II receptor blockers (ARBs) drugs such as ranitidine, nizatidine, and metformin for nitrosamine impurities since the end of 2020 and the USFDA since February 2021. AZ-Biopharm can support you in releasing your medication with a highly sensitive UHPLC-MSMS method. The current limit of quantification (LOQ) of the validated UHPLC-MSMS method for NDMA is 0.576 ng/ml, which corresponds to 0.0144 ppm in the sample (= 30% of the specification level of the metformin 1000 mg tablet). The detection limit (LOD) of this method is 0.288 ng/mL in solution, which corresponds to 0.0072 ppm in the sample (= 15% of the specification level with a signal-to-noise ratio> 10). Taking into account the signal-to-noise ratio> 10, there is the potential for a LOQ of 10% of the specification level (metformin), which would be particularly attractive for a reduced analysis volume.
Additionally, we at AZ-Biopharm established a screening method for 12 nitrosamines. The method combines the detection of N-nitroso-dimethylamine (NDMA), N-nitroso-diethylamine (NDEA), N-nitroso-dipropylamine (NDPA), N-nitroso-dibutylamine (NDBA), N-nitroso-piperidine (NPIP), N-nitroso-pyrrolidine (NPYR), N-nitroso-morpholine (NMOR), N-nitroso-methyl-ethylamine (NMEA), N-nitroso-methyl-4-amio-butyric acid (NMBA), N-nitroso-methylaniline (NMPhA), N-nitroso-ethyl-isopropylamine (NEIPA) and N-nitroso-diisopropylamine (NDIPA) in a single run. Based on our experience with the substance class of Nitrosamines, especially the problematic NDMA, we are able to quantify further Nintrosamines with the screening method.
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