Rapid and Quantitative Screening of Nitrosamines in Drug Products Using Headspace-SIFT-MS

This study demonstrates that headspace-SIFT-MS meets United States Pharmacopeia (USP) criteria for six nitrosamines, achieving low limits of quantitation (0.06 ppm for NDMA and 0.03 ppm for NDEA) even in complex drug matrices. With high recovery rates and significant reductions in solvent usage, consumables, and operational complexity compared to traditional chromatographic methods, the Syft Tracer Pharm11 solution is an efficient screening tool for nitrosamines and volatile impurities.