Generic method approach for determination of residual solvents in active pharmaceutical ingredients by gas chromatography

Solvents are defined as organic chemicals that are used to dissolve components; they are used during the manufacture of drug substances. Solvents can also potentially be formed as by-products of the synthetic process. Depending on their structure, solvents have varying degrees of toxicity. Upon completion of the synthetic process, an objective is to remove completely or reduce the residual levels of these solvents to points at which they pose no risk to patient safety in the final formulated drug product.