Class 2 Residual Solvents
Residual solvents are separated into three classes based on risk assessment or their potential toxicity level. Because of its inherant toxicities, class 2 residual solvents should be limited in drug substances, excipients, and drug
The following is a list of class 2 residual solvents as well as their acceptable levels as adopted by the International Conference on Harmonization (ICH Q3C).
USP Class 2 Residual Solvents List
|Solvent||PDE (mg/day)||Concentration limit (ppm)|
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