Quantitative Analysis of Nitrosamines
A very sensitive method with limits of quantitation (LOQ) in the parts-per-billion (ppb) range is needed to meet the FDA requirements for nitrosamine analysis. According to FDA guidance, manufacturers of APIs and drug products are directed to use methods with LOQs at or below 30 ppb. FDA recommends using LC-HRMS methods to quantitate nitrosamine impurities in drug substances or drug products.
N-Nitroso-dimethylamine (NDMA)
N-Nitroso-diethylamine (NDEA)
N-Nitroso-methylphenylamine (NMPA)
N-Nitroso-diisopropylamine (NDIPA)
N-Nitroso-isopropylehylamine (NIPEA)
N-Nitroso-di-n-butylamine (NDBA)
N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
At Qmera, nitrosamine quantitation is performed using a method with LOQ equal to or below 1 ng/ml (1 ppb) that relies on our HRMS expertise and instrumentation.
Variation in APIs and drug products is expected, and Qmera offers a short method development exercise to confirm that assay quality attributes such as LOD, LOQ, specificity, accuracy, and precision are suitable for your specific product formulation.