Residual Solvents

The synthesis of active pharmaceutical ingredients (API) may require multiple reaction steps that produce undesirable reaction byproducts or utilize various solvents that must be removed from the finished product. These solvents and byproducts may be measured with headspace gas chromatography for those volatile residual organic solvents according to the USP chapter <467> method and ICH Q3C guidelines.

Residual solvents in drug substances, excipients, and in drug products should be tested using analytical techniques to ensure levels of residual solvents are meeting criteria established by ICH Q3C guidelines. Any harmonised procedures for determining levels of residual solvents as described in the pharmacopoeias should be used, if feasible. Otherwise, manufacturers would be free to select the most appropriate validated analytical procedure for an application.

We provide the tools you need for you to take control of residual solvents testing.