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.

Static Headspace Analysis of Residual Solvents in Flexible Packaging and Quantitation with Multiple Headspace Extraction Following EN 13628-1:2002

Instrument Type: GC

Goal of this application is to demonstrate the applicability of a modern, high-throughput valve-and-loop static headspace autosampler to obtain full compliance with the European Standard EN 13628-1, which specifies guidelines for the quantitative determination of residual solvents in flexible packaging by Multiple Headspace Extraction methodology. The Thermo Scientific Trace1310 GC coupled with the Triplus300 HS have been used for this purpose.