[Case Study] Residual Solvent Analysis Using a New Headspace GC-FID

Robust residual solvent analysis by headspace GC-FID meeting the requirements of USP<467> method.

Organic solvents are widely used in the synthesis of pharmaceuticals, but they cannot always be completely removed during the manufacturing process. To ensure safety, the final product is tested to evaluate whether the solvents used have been efficiently removed and, if any remain, whether their concentrations are within acceptable limits. The United States Pharmacopeia (USP) method <467> provides detailed procedures for screening, confirming, and quantifying residual solvents, including sample preparation and analytical conditions. The new TriPlus 500 HS autosampler adopts an innovative design with a flow path that directly connects the heated valve to the GC column. This means high-precision sample introduction and excellent reproducibility of peak areas. Furthermore, by continuously purging the sample path, the robustness and reliability of the system are ensured, reducing the risk of contamination and carryover (which is important when analyzing high-boiling residual solvents). This technical document reports the results of residual solvent analysis conducted in accordance with USP <467>, using the TriPlus 500 HS autosampler and FID as the optimal detector.

Analytical Equipment and Devices