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. 2018 Dec 26;4(12):e01088. doi: 10.1016/j.heliyon.2018.e01088

Table 1.

Different classes of solvents in pharmaceutical products and their suggested concentration limits [25, 26, 27].

Class 1
Solvents to be avoided
Class 2
Solvents to be limited
Class 3
Solvents with low risk
Solvent Limit (ppm) Solvent Limit (ppm) Solvent Limit (%w/w)
Benzene 2 Acetonitrile 410 Acetic acid 0.5
Carbon tetrachloride 4 Chlorobenzene 360 Anisole 0.5
1,1-Dichloroethene 8 Chloroform 60 Butyl acetate 0.5
1,2-Dichloroethane 5 Cyclohexane 3880 Formic acid 0.5
1,1,1-Trichloroethane 1500 Dichloromethane 600 Heptane 0.5
Hexane 290 Isobutyl acetate 0.5
Methanol 3000 Methyl acetate 0.5
Sulfolane 160 Pentane 0.5
Tetralin 100 Propyl acetate 0.5
Xylene 2170 Tetrahydrofuran 0.5