Simple, Rapid Analysis of N-nitrosodimethylamine (NDMA) Impurity in Ranitidine Products Using SIFT-MS

Quantitative analysis of volatile nitrosamine impurities in drug products is greatly simplified using SIFT-MS and has a three-fold throughput advantage (excluding sample prep benefits) over chromatographic methods.

Abstract

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 (three times faster than gas and liquid chromatography methods assuming they utilize fully automated sample preparation) and only 70 minutes to first result (including full calibration set; over twice as fast as chromatographic methods). This application note describes 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.