Class 3 Residual Solvents
Residual solvents are separated into three classes based on risk assessment or their potential toxicity level. Class 3 residual solvents are limited by GMP or other quality-based requirements in drug substances, excipients, and
As outlined in USP <467>, analysis of Class 3 solvents is performed by USP Loss on drying <731> provided the test is specified in the monograph. If there is no LOD specified or the limit is greater than 0.5%, a suitable validated method will be required for analysis.
USP Class 3 Residual Solvents List
|Ethyl formate||Propyl acetate|
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