3.2. Gas chromatography and GC/MS

Abstract

Residual solvents can be a health hazard as well as they affect physicochemical properties like particle size, dissolution rate and stability. Physicochemical properties however, can be influenced by residual solvents in a positive way as residual levels of solvents provide better stability and solubility for some products. Thus it seems not generally justified to reduce residual solvents to the lowest possible level. Therefore, GMP rules need to reduce residual solvents to merely reasonable levels. Nevertheless, studies that deal with the optimisation of production processes to eliminate residual solvents are useful. Determination of residual solvents—for example, through headspace-gas chromatography with mass spectrometric detection—contributes to the characterisation of illicit drugs, supplying information on their source and other relevant forensic parameters. Residual solvents can prove the correctness as well as the authenticity of a production process, which means that a number of product characteristics can be indirectly certified and identified through analysis of residual solvents as their fingerprint.