The United States Pharmacopeia (USP) General Chapter <467> Residual Solvents is a widely used compendial method intended for identifying and quantifying residual solvents in drug substances, drug products, and excipients. In an attempt to better mirror the International Conference on Harmonization (ICH) guidelines, the USP has adopted a more comprehensive methodology in residual solvent testing—the current USP30/NF25. The ICH publishes a guideline (Q3C) listing the acceptable amounts of solvent residues that can be present. In the ICH guideline, residual solvents are summarized by class according to their toxicity. Class 1 compounds are carcinogenic compounds that pose a risk to both the consumer and the environment. The use of these solvents is to be avoided, but if they are used, they must be tightly controlled. Class 2 compounds are nongenotoxic animal carcinogens, and concentrations of these compounds should be limited. Chromatographic analysis is needed for both the Class 1 and Class 2 residual solvents.
This mixture reflects the changes made in USP <467> effective August 2013 and replaces Restek cat.# 36271.
Acetonitrile (75-05-8), 2.05 mg/mL
Chlorobenzene (108-90-7), 1.8 mg/mL
Cyclohexane (110-82-7), 19.4 mg/mL
cis-1,2-Dichloroethene (156-59-2), 4.675 mg/mL
trans-1,2-Dichloroethene (156-60-5), 4.675 mg/mL
1,4-Dioxane (123-91-1), 1.9 mg/mL
Ethylbenzene (100-41-4), 1.84 mg/mL
Isopropylbenzene (cumene) (98-82-8), 0.35 mg/mL
Methanol (67-56-1), 15 mg/mL
Methylcyclohexane (108-87-2), 5.9 mg/mL
Methylene chloride (dichloromethane) (75-09-2), 3 mg/mL
Tetrahydrofuran (109-99-9), 3.6 mg/mL
Toluene (108-88-3), 4.45 mg/mL
m-Xylene (108-38-3), 6.51 mg/mL
o-Xylene (95-47-6), 0.98 mg/mL
p-Xylene (106-42-3), 1.52 mg/mL
