Pharmaceutical Residual Solvent Analysis: A Comparison of GC-FID and SIFT-MS Performance

Residual solvents in pharmaceutical excipients, active ingredients (APIs), and finished products are usually analyzed using gas chromatography (GC)-based techniques according to a pharmacopeial monograph, such as the United States Pharmacopeia’s (USP) chapter <467>. GC analyses often slow, which limits sample throughput. Selected ion flow tube mass spectrometry (SIFT-MS) removes rate-limiting chromatographic separation step, potentially offering faster analyses. This approach was demonstrated recently with publication of an alternative SIFT-MS procedure successfully validated against performance criteria USP <1467>. The present study expands upon previous work by conducting head-to-head comparison GC-flame ionization detection (GC-FID) procedures. results obtained this cross-platform similar for GC-FID procedures linearity (R2 > 0.94 0.97, respectively) repeatability (<17%RSD <10%RSD). For accuracy recovery, acceptance (within 20%) were achieved most compounds across two drug (SIFT-MS suffered fewer failures, possibly due shorter wait times prior analysis). Additionally, samples over 11-fold than GC-FID, increasing daily throughput reducing time taken determine result. therefore suggests that residual solvent analysis may support workflow improvements manufacturers.