11-145 Konrad Cres., Markham, Ontario Canada L3R 9T9
Toll Free: 1.877.305.0998 Telephone: 905 305 0998

USP <467> and ICH Q3C Residual Solvents Determination

Faster Analysis & Enhanced Sensitivity

There are now 57 solvents listed as either Class 1 (unacceptable due to toxicity), Class 2 (solvents without adequate Toxicological Data) or Class 3 (least toxic, preferred solvents), all of which need to be screened and if identified subsequently quantified under proposed USP (and existing EP) guidelines. QCL – Quality Compliance Laboratories offers expert service for the analysis of residual solvents which includes:


Class 1 Residual Solvents

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

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)

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

USP Class 3 Residual Solvents

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

USP Class 3 Residual Solvents - for Acetic acid & Formic acid by Direct injection


Performed upon request


Our laboratory is set up for throughput, with state of the art Agilent GC’s and associated headspace units. We are committed to ongoing, effective upgrades in software and instrumentation so our clients benefit from faster, more selective and sensitive testing, as it becomes available.

Typically samples are tested within 7 working days of receipt. Rush testing can be performed upon request. The QCL laboratory is registered and inspected by both Health Canada and the U.S. Food and Drug Administration (FDA).