A Generic Method for the Analysis of Residual Solvents in Pharmaceuticals Using Static Headspace-GC-FID/MS

The determination of residual solvents in pharmaceuticals is one of the most important gas chromatography (GC) applications in quality assurance/quality control (QA/QC) in the pharmaceutical industry. Sample introduction is normally done using static headspace (SHS). In routine QC, GC with flame ionization detection (FID) is preferred, while mass spectrometry (MS) can be used for screening and identification. In this application note, a retention-time locked GC-MS/FID method is presented that allows the analysis of more than 50 solvents in a single run. The method was optimized to allow identification and quantification of all three International Conference on Harmonisation (ICH) classes of solutes at relevant concentration levels. Authors Karine Jacq, Frank David, and Pat Sandra Research Institute for Chromatography, Pres. Kennedypark 26, B-8500 Kortrijk, Belgium Matthew S. Klee Agilent Technologies, Inc. 2850 Centerville Road Wilmington, DE 19808 USA Application Note