Table 1.
Residual solvent limits imposed by ICH and USP (International Community of Harmonization (ICH), 2011; United States Pharmacopeia (USP), 2009)
Solvent | Limit (ppm) | ||
---|---|---|---|
Class 3 | 2-butanol | < 5000 | |
Acetone | < 5000 | ||
Butanone/methyl ethyl ketone | < 5000 | ||
Diethyl ether | < 5000 | ||
Ethanol | < 5000 | ||
Ethyl acetate | < 5000 | ||
Isopropanol (IsoOH) | < 5000 | ||
Methyl tertbutyl ether (MTBE) | < 5000 | ||
Class 2 | 1.4-Dioxane | < 380 | |
Acetonitrile | < 410 | ||
Chlorobenzene | < 360 | ||
Cyclohexane | < 3880 | ||
Cumene/isopropyl benzene | < 70 | ||
Methanol | < 3000 | ||
Methyl cyclohexane | < 1180 | ||
Methylene chloride | < 600 | ||
Ethylbenzene | Total xylenes | < 2170 | |
o-xylene | |||
p- and m-xylene | |||
Tetrahydrofuran | < 720 | ||
Toluene | < 890 | ||
Trans 1,2-dichloroethene | Total dichloroethenes | < 1870 | |
cis-dichloroethene | |||
Class 1 | Benzene | < 2 |