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Analyzing Residual Solvents in Pharmaceutical Products Using GC Headspace with Valve-and-Loop Sampling

Instrument Type: GC

This application note describes the analysis of residual solvents in accordance with USP method <467> using the Thermo Scientific™ TRACE™ 1310 GC, the new Thermo Scientific™ TriPlus™ 300 Headspace autosampler, and the Thermo Scientific™ Dionex™ Chromeleon™ chromatography data system (CDS) software. The method details the chromatographic system and analytical conditions to be used and addresses the acceptable limits for each solvent.