Background
Residual solvents inpharmaceuticals are defined as volatile
organic chemicals that are usedor produced in the
manufacture of drug substances or excipients, or in the
preparation of drugproducts. The solvents are not
completely removedby practicalmanufacturing techniques.
Since there is noknown therapeutic benefit from residual
solvents, all residual solvents shouldbe removed to the extent
possible tomeet product specifications, goodmanufacturing
practices or other quality based requirements.
