Residual solvents according to Chinese Pharmacopoeia.

The level of volatile organic solvents in pharmaceutical raw materials or finished product is defined and monitored. Residual solvents are classified according to their risk assessment classes. A selection of residual solvent standards is now available from Avantor.

Class III MIX A: 25 components; 5000 mg/l each of acetone; anisole; 1-butanol; 2-butanol; 2-butanone; n-butylacetate; diethylether; dimethylsulphoxide; ethanol; ethyl acetate; ethyl formate; n-heptane; 2-methyl-1-propanol; acetic acid-isobutyl ester; acetic acid-isopropyl ester; methyl acetate; isoamyl alcohol; 4-methyl-2-pentanone; methyl-tert.butylether; n-pentane; 1-pentanol; 1-propanol; 2- propanol; acetic acid n-propyl ester; isopropylbenzene (cumene) in dimethylformamide

Class III MIX B: 2 components; 5000 mg/ml each of acetic acid; formic acid in dimethylformamide