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 VWR.
Class III Mix A: 23 components; 5000 µg/ml each of n-heptane; acetone; acetic acid-isobutyl ester; anisole; acetic acid-isopropyl ester; 1-butanol; methyl acetate; 2-butanol; isoamyl alcohol; n-butylacetate; 2-butanone; methyl-tert.butylether; 2-methyl-1-propanol; dimethyl sulphoxide; n-pentane; ethanol; 1-pentanol; ethyl acetate; 1-propanol; diethylether; 2- propanol; ethyl formate; acetic acid n-propyl ester in dimethylformamide
Class III Mix B: 2 components; 5000 µg/ml each of acetic acid; formic acid in dimethylformamide
Class III Mix C: 5000 µg/ml triethylamine in water
Certifications: Conforms to ICH guidelines.
Residual Solvents Class 3 acc. to Ph. Eur. Version 10 and USP 467.
Delivery information: Supplied with a comprehensive Certificate of Analysis.