Simple, rapid analysis of NDMA impurity in ranitidine products using SIFT-MS

Mutagenic N-nitrosamine impurities are found at trace concentrations in certain pharmaceutical products as byproducts of synthesis or, less commonly, through migration from packaging materials. They are traditionally analyzed using chromatographic techniques that require significant sample preparation and have relatively low sample throughputs. SIFT-MS simplifies and speeds up analysis of trace volatile N-nitrosamine impurities, with a throughput of 12 samples/hr and only 70 minutes to first result. This application note from Syft Technologies details how the headspace-SIFT-MS analysis of ranitidine products and achieves a limit of quantitation of 2 ng g-1 for NDMA in 500 mg of drug product.