The level of volatile organic solvents in pharmaceutical raw materials or finished product is defined and monitored in accordance with ICH guidelines. Residual solvents are classified according to their risk assessment classes. A selection of residual solvent standards is now available from Avantor.
- Conforms to the latest Ph. Eur. edition
- Conforms to ICH guidelines
- Delivered with comprehensive Certificate of Analysis
- Packed in 1 ml or 1,5 ml glass ampoules
Class I: Benzene, 1,2- dichloroethane, 1,1- dichloroethane, tetrachloromethane, 1,1,1- trichloroethane.
Class IIa: Chlorobenzene, cyclohexane, 1,2-dichloroethene (cis-/- trans), dichloromethane, dimethylformamide, ethylbenzene, n-hexane, methylcyclohexane, toluene, trichloroethene, m-xylene, o-xylene, p-xylene.
Class IIb: Acetonitrile, chloroform, 1,2-dimethoxyethane, N,N-dimethylacetamide, dioxane, 2-hexanone, methanol, nitromethane, pyridine, tetrahydronaphthalene.
Class IIc: Ethyleneglycol-monoethyl ether, ethyleneglycol, formamide, ethyleneglycol-monomethyl ether, 1-methyl-2-pyrrolidone, sulpholane.
Certifikace: Conforms to the latest Ph. Eur. edition.
Conforms to ICH guidelines.
Informace o dodávce: Supplied with a comprehensive Certificate of Analysis.
Balení: Packed in 1 or 1,5 ml glass ampoules.