Nitrosamine analysis from aqueous solutions using headspace-SIFT-MS

Nitrosamines have been classified as belonging to the Cohort of Concern (CoC) in the International Council for Harmonisation (ICH) M7 with stringent AI limits, and drug manufacturers frequently perform impurity testing to meet such regulatory guidelines. Selected ion flow tube mass spectrometry (SIFT-MS) provides rapid, sensitive, and selective quantitation of nitrosamines in pharmaceutical drug products. This application note describes an alternative approach to quantifying nitrosamines using SIFT-MS: static headspace analysis (SHA) of dissolved drug products. See how headspace-SIFT-MS analysis achieves excellent linearity and limits of detection (<10% of the acceptable daily intake (AI) limits) for six nitrosamines.