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瀏覽器自帶分享功能也很好用哦~When studying the residual solvents of the compatible extracts and extracts of pharmaceutical packaging materials, the residual solvents in the pharmaceutical packaging materials were identified and risk assessed according to the classification and limit of the residual solvents in ICH-Q3C.
Class 1
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 | ||||||
Solvent | PDE (mg/day) | Concentration limit (ppm) | ||||
Acetonitrile | 4.1 | 410 | ||||
Chlorobenzene | 3.6 | 360 | ||||
Chloroform | 0.6 | 60 | ||||
Cumene | 0.7 | 70 | ||||
Cyclohexane | 38.8 | 3880 | ||||
Cyclopentyl methyl ether | 15.0 | 1500 | ||||
1,2-Dichloroethene | 18.7 | 1870 | ||||
Dichloromethane | 6.0 | 600 | ||||
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-Ethoxyethano | 1.6 | 160 | ||||
Ethyleneglycol | 6.2 | 620 | ||||
Formamide | 2.2 | 220 | ||||
Hexane | 2.9 | 290 | ||||
Methanol | 30.0 | 3000 | ||||
2-Methoxyethanol | 0.5 | 50 | ||||
Methylbutyl ketone | 0.5 | 50 | ||||
Methylcyclohexane | 11.8 | 1180 | ||||
Methylisobutylketone | 45 | 4500 | ||||
N-Methylpyrrolidone | 5.3 | 530 | ||||
Nitromethane | 0.5 | 50 | ||||
Pyridine | 2.0 | 200 | ||||
Sulfolane | 1.6 | 160 | ||||
Tertiary-butyl alcohol | 35 | 3500 | ||||
Tetrahydrofuran | 7.2 | 720 | ||||
Tetralin | 1.0 | 100 | ||||
Toluene | 8.9 | 890 | ||||
1,1,2-Trichloroethene | 0.8 | 80 | ||||
Xylene* | 21.7 | 2170 | ||||
* usually 60% m-xylene, 14% p-xylene, 9% o-xylene with 17% ethyl benzene | ||||||
Class 3
| ||||||
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 | 2-Methyl-1-propanol | |||||
Dimethyl sulfoxide | 2-Methyltetrahydrofuran | |||||
Ethanol | Pentane | |||||
Ethyl acetate | 1-Pentanol | |||||
Ethyl ether | 1-Propanol | |||||
Ethyl formate | 2-Propanol | |||||
Formic acid | Propyl acetate | |||||
Triethylamine | ||||||
When studying the residual solvents of the compatible extracts and extracts of pharmaceutical packaging materials, the residual solvents in the pharmaceutical packaging materials were identified and risk assessed according to the classification and limit of the residual solvents in ICH-Q3C.
Class 1
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 | ||||||
Solvent | PDE (mg/day) | Concentration limit (ppm) | ||||
Acetonitrile | 4.1 | 410 | ||||
Chlorobenzene | 3.6 | 360 | ||||
Chloroform | 0.6 | 60 | ||||
Cumene | 0.7 | 70 | ||||
Cyclohexane | 38.8 | 3880 | ||||
Cyclopentyl methyl ether | 15.0 | 1500 | ||||
1,2-Dichloroethene | 18.7 | 1870 | ||||
Dichloromethane | 6.0 | 600 | ||||
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-Ethoxyethano | 1.6 | 160 | ||||
Ethyleneglycol | 6.2 | 620 | ||||
Formamide | 2.2 | 220 | ||||
Hexane | 2.9 | 290 | ||||
Methanol | 30.0 | 3000 | ||||
2-Methoxyethanol | 0.5 | 50 | ||||
Methylbutyl ketone | 0.5 | 50 | ||||
Methylcyclohexane | 11.8 | 1180 | ||||
Methylisobutylketone | 45 | 4500 | ||||
N-Methylpyrrolidone | 5.3 | 530 | ||||
Nitromethane | 0.5 | 50 | ||||
Pyridine | 2.0 | 200 | ||||
Sulfolane | 1.6 | 160 | ||||
Tertiary-butyl alcohol | 35 | 3500 | ||||
Tetrahydrofuran | 7.2 | 720 | ||||
Tetralin | 1.0 | 100 | ||||
Toluene | 8.9 | 890 | ||||
1,1,2-Trichloroethene | 0.8 | 80 | ||||
Xylene* | 21.7 | 2170 | ||||
* usually 60% m-xylene, 14% p-xylene, 9% o-xylene with 17% ethyl benzene | ||||||
Class 3
| ||||||
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 | 2-Methyl-1-propanol | |||||
Dimethyl sulfoxide | 2-Methyltetrahydrofuran | |||||
Ethanol | Pentane | |||||
Ethyl acetate | 1-Pentanol | |||||
Ethyl ether | 1-Propanol | |||||
Ethyl formate | 2-Propanol | |||||
Formic acid | Propyl acetate | |||||
Triethylamine | ||||||
滬ICP備2022003614號-1
