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.

Residual Solvents Class 2 acc to Ph Eur Ver 10 Mix A: 14 components; chlorobenzene 360 ug/ml; cyclohexane 3880 ug/ml; cis-1,2-dichloroethene 1870 ug/ml; dichloromethane 600 ug/ml; ethylbenzene 369 ug/ml; n-hexane 290 ug/ml; methylcyclohexane 1180 ug/ml; dimethylformamide (N,N - dimethylformamide) 880 ug/ml; toluene 890 ug/ml; trichloroethene (1,1,2-trichloroethene) 80 ug/ml; m-xylene 1302 ug/ml; o-xylene 195 ug/ml; p-xylene 304 ug/ml; tetrahydrofuran 720 ug/ml in dimethylsulphoxide.

Residual Solvents Class 2 acc. to Ph Eur Ver 10 Mix B: 11 components; acetonitrile 410 mg/L; chloroform 60 mg/L; 1,2-dimethoxyethane 100 mg/L; N,N-dimethylacetamide 1090 mg/L; dioxan 380 mg/L; 2-hexanone 50 mg/L; methanol 3000 mg/L; nitromethane 50 mg/L; pyridine 200 mg/L; 1,2,3,4-tetrahydronaphthalene 100 mg/L; isopropylbenzene (cumene) 70 mg/L in dimethylsulphoxide / water (9/1).

Residual Solvents Class 2 acc. to Ph Eur Ver 10 Mix C: 7 components; ethyleneglycol-monoethyl ether (2-Ethoxyethanol) 160 mg/L; ethylene glycol 620 mg/L; formamide 220 mg/L; ethyleneglycol-monomethyl ether (2-methoxyethanol) 50 mg/L; 1-methyl-2-pyrrolidon (N-methyl pyrrolidone) 530 mg/L; sulfolan 160 mg/L; 4-methyl-2-pentanone 4500 mg/L in water.

Residual Solvents Class 2 acc to Ph Eur 8.8 MIX C: 6 components ethyleneglycol-monoethyl ether (2-ethoxyethanol)160 mg/L; ethyleneglycol 620 mg/L; formamide 220 mg/L; ethyleneglycol-monomethyl ether (2-methoxyethanol) 50 mg/L; 1-methyl-2-pyrrolidone 4840 mg/L; sulfolan 160 mg/L in water.