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 and 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, it becomes an objective 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.  Typically, there is no technique via which solvents can be completely removed from pharmaceutical ingredients or products. Therefore, it is necessary to have a suitable analytical technique according to which materials can be tested to assure that the levels of solvents are below those that are classified as safe by regulatory guidelines. Download this whitepaper to read more about an analytical technique for the determination of residual solvents in drug substances, with method data presented by James Sweatman, Analytical Investigator, Almac Sciences.