4
Table
1
Class
3 Solvents
International Conference on Harmonization Endorsed by the FDA*
Acetic
acid
Heptane
Acetone
Isobutyl
acetate
Anisole
Isopropyl
acetate
1-Butanol
Methyl
acetate
2-Butanol
3-Methyl-1-butanol
Butyl
acetate
Methylethyl
ketone
tert-Butylmethyl
ether
Methylisobutyl
ketone
Cumene
2-Methyl-1-propanol
Dimethyl
sulfoxide
Pentane
Ethanol
1-Pentanol
Ethyl
acetate
1-Propanol
Ethyl
ether
2-Propanol
Ethyl
formate
Propyl
acetate
Formic
acid
*Should
Be Limited by GMP or Other Quality-Based Requirements
Figure
2. Permeability Constants of Commercial Solvents
(g/m
2
h)
Dimethyl
Sulfoxide
176
± 42
N-methyl
pyrrolidone (NMP)
171
± 59
Dimethyl
acetamide
107
± 19
Dimethyl
formamide (DMF)
98 ±
1.1