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 |