Analysis of Residual Solvents - Class 1, Class 2A, Class 2B - in Pharmaceuticals Using Headspace-GC/MS

According to the USP, General Chapter <467> Residual Solvents" method, analysis of residual solvents in pharmaceuticals is to be conducted by the headspace GC-FID method (HS-GC). However in this application, we investigated using headspace-GC/MS (HS-GC/MS) according to Procedure A. Using the HS-GC method, measurement is to be performed as three separate analyses, which are required to achieve chromatographic separation within the three different classes of compounds, Class 1, Class 2A, and Class 2B. However, using HS-GC/MS, complete chromatographic separation is not necessary, so all the compounds can be analyzed in a single run. In addition, compound confirmation and qualitative information of unknown peaks can also be obtained.