Table 1 Residual solvent limits imposed by ICH and USP (International Community of Harmonization (ICH), 2011; United States Pharmacopeia (USP), 2009)

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