USP Monograph Development Process and Compendial Updates

Residual Solvents• Testing of drug substances, excipients, and drugproducts for residual solvents should be performedwhen production or purification processes areknown to result in the presence of such residualsolvents.• It is only necessary to test for residual solvents thatare used or produced in the manufacture orpurification processes.• Solvent used or produced in the final manufacturingstep and solvents that are used or produced inearlier manufacturing steps and not removedconsistently by a validated process.