News|Articles|February 21, 2024

Analysis of N-Nitrosodimethylamine (NDMA) Impurity in Rantidine 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. This application note describes the headspace-SIFT-MS analysis of ranitidine products which achieves a limit of quantitation of 2 ng g-1 for NDMA in 500 mg of drug product.

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