Residual solvent testing for pharmaceutical, nutraceutical and biopharmaceutical materials is performed in the QCL laboratory for a cost of approximately one thousand dollars. This includes Class 1, Class 2 (mixture A and B) and Class 3 Residual solvent testing performed via Headspace GC as per USP <467>.

Class 1 Residual Solvents

Benzene
Carbon tetrachloride
1,2-Dichloroethane
1,1-Dichloroethene
1,1,1-Trichloroethane

Class 2 Residual Solvents (USP Mixture A and B)

Acetonitrile
Chlorobenzene
Chloroform
Cyclohexane
1,2-Dichloroethene
1,4-Dioxane
Hexane
Methanol
Methylbutylketone
Methylcyclohexane
Methylene chloride
Nitromethane
Tetrahydrofuran
Tetralin
Toluene
Trichloroethylene
Xylenes

USP Class 2 Direct Injection (USP Mixture C - performed upon request at an additional charge)

Formamide
2-ethoxyethanol
2-methoxyethanol
Ethylene glycol
N-methylpyrrolidone
Sulfolane
Pyridine

USP Class 3 Residual Solvents

Acetic acid
Acetone
Anisole
1-Butanol
2-Butanol
Butyl acetate
tert-Butylmethyl ether
Cumene
Dimethyl sulfoxide
Ethanol
Ethyl acetate
Ethyl ether
Ethyl formate
Formic acid
Heptane
Isobutyl acetate
Methyl acetate
3-Methyl-1-butanol
Methylethylketone
Methylisobutylketone
2-Methyl-l-propanol
Pentane
1-Pentanol
1-Propanol
2-Propanol
Propyl acetate

• Adherence to ICH/USP
• Detection, profiling and reporting of residual solvents
• Screening for potential interference
• Assistance in regulatory reporting
• Comprehensive and accurate reports

Our laboratory is set up for throughput, with state of the art Agilent GC’s and associated headspace units. Typically samples are tested within 10 days of receipt. Rush testing can be performed at an additional charge. The QCL laboratory is inspected federally and relevant inspection documents are available on request. QCL is under license with Health Canada and registered with the U.S. Food and Drug Administration (FDA).

Let QCL be your source for residual solvent testing

Telephone: 905.305.0998
Toll Free: 1.877.305.0998
Email: qcl@qctest.com