Contract development and manufacturing organizations (CDMOs) are essential for the testing of pharmaceutical products for their safety and efficacy. Many analytical tests are run in accordance with federal regulations and guidelines, including the analysis of residual solvents, extractables, leachables, degradation products and impurities in excipients. These tests require a plethora of instrumentation and trained users to operate these individual tests. In this webinar, we introduce our new compliant real-time mass spectrometer solution, Syft Tracer Pharm11. A single instrument is capable of running up to 220 samples per day, and multiple methods and analyses can be performed in sequence. The direct headspace-SIFT-MS instrument is chromatography-free, and therefore the need for multiple columns and instrument downtime between methods does not exist.
We will highlight several common CDMO tests that have been performed and validated using headspace SIFT-MS, including residual solvents, ethylene oxide, nitrosamines and other extractables & leachables.