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ICH-Q3C殘留溶劑 ICH-Q3C residual solvent

我們在研究藥包材相容性可提取物與浸出物的殘留溶劑時，依據ICH-Q3C殘留溶劑中的分類與限值，對藥包材中的殘留溶劑進行鑒定與風險評估。
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.

產品詳情

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

ICH-Q3C殘留溶劑 ICH-Q3C residual solvent

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藥包材相容性 Pharmaceutical packaging compatibility

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濕巾-濕紙巾，濕廁紙，廚房濕紙巾檢測Wet wipes-Wet tissue, wet toilet wipes, wet kitchen towel

產品詳情

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