Class 3 Residual Solvents

Analytical testing dots 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 drug products.

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.

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USP Class 3 Residual Solvents List

Acetic acid Heptane
Acetone Isobutyl acetate
Anisole Isopropyl acetate
1-Butanol Methyl acetate
2-Butanol 3-Methyl-1-butanol
Butyl acetate Methylethylketone
tert-Butylmethyl ether Methylisobutylketone
Cumene 2-Methyl-l-propanol
Dimethyl sulfoxide Pentane
Ethanol 1-Pentanol
Ethyl acetate 1-Propanol
Ethyl ether 2-Propanol
Ethyl formate Propyl acetate
Formic acid

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