Residual Solvents

USP <467>, Residual Solvents

Residual solvents assessed in USP <467> were evaluated by gas chromatography for their possible risk to human health and placed into one of three classes as follows:

 

Class 1 Residual Solvents: Solvents to be avoided, known human carcinogens, strongly suspected human carcinogens, and environmental hazards

Solvent Concentration
Limit (ppm)
Concern
Benzene 2 Carcinogen
Carbon tetrachloride 4 Toxic and environmental hazard
1,2-Dichloroethane 5 Toxic
1,1-Dichloroethene 8 Toxic
1,1,1-Trichloroethane 1500 Environmental hazard

 

Class 2 Residual Solvents: Solvents to be limited, nongenotoxic animal carcinogens or possible causative agents of other irreversible toxicity, such as neurotoxicity or teratogenicity, and solvents suspected of other significant but reversible toxicities

Solvent PDE
(mg/day)
Concentration
Limit (ppm)
Acetonitrile 4.1 410
Chlorobenzene 3.6 360
Chloroform 0.6 60
Cyclohexane 38.8 3880
1,2-Dichloroethene 18.7 1870
1,2-Dimethoxyethane 1.0 100
N,N-Dimethylacetamide 10.9 1090
N,N-Dimethylformamide 8.8 880
1,4-Dioxane 3.8 380
2-Ethoxyethanol 1.6 160
Ethylene glycol 6.2 620
Formamide 2.2 220
Hexane 2.9 290
Methanol 30.0 3000
2-Methoxyethanol 0.5 50
Methylbutylketone 0.5 50
Methylcyclohexane 11.8 1180
Methylene chloride 6.0 600
N-Methylpyrrolidone 5.3 530
Nitromethane 0.5 50
Pyridine 2.0 200
Sulfolane 1.6 160
Tetrahydrofuran 7.2 720
Tetralin 1.0 100
Toluene 8.9 890
Trichloroethylene 0.8 80
Xylene 21.7 2170
*Usually 60% m-xylene, 14% p-xylene, 9% o-xylene with 17% ethyl benzene

 

Class 3 Residual Solvents: Solvents with low toxic potential. No health-based exposure limit is needed.

Acetic acid Heptane
Acetone Isobutyl acetate
Anisole Isopropyl acetate
1-Butanol Methyl acetate
2-Butanol 3-Methyl-1-butanol
Butyl acetate Methylethylketone
tert-Butylmethyl ether Methylisobutylketone
Cumene 2-Methyl-l-propanol
Dimethyl sulfoxide Pentane
Ethanol 1-Pentanol
Ethyl acetate 1-Propanol
Ethyl ether 2-Propanol
Ethyl formate Propyl acetate
Formic acid

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