The Q3C ICH Guideline was finalised under Step 4 in July 1997, providing recommendations on the use of less toxic solvents in the manufacture of drug substances and dosage forms, and setting pharmaceutical limits for residual solvents (organic volatile impurities) in drug products.
Maintenance Process
A Maintenance process for the Q3C Guideline was set up to enable the revision and inclusion of new Permitted Daily Exposure (PDE) levels as new toxicological data for solvents become available.
