Restek is a long-time partner of pharmaceutical QC labs performing residual solvent analysis, and our support continues with the release of an updated Class 2 Mix A reference standard. This standard has been reformulated to include cumene, which was added to the USP Class 2 list in August 2013, and allows labs to successfully detect and quantify solvent residues in compliance with the latest USP <467> guidelines.
As with our other USP <467> mixes, this standard is prepared with the superior quality and reliability you have come to expect from Restek. It is quantitatively tested to confirm composition and stability, and detailed documentation is provided. In addition, being manufactured and QC-tested in Restek’s ISO-accredited labs means this standard will also help satisfy strict ISO requirements for the use of certified reference materials (CRMs).
Restek is your complete supplier for world-class USP <467> residual solvent analysis. Get the up-to-date reference standards, Rxi®-624Sil MS (G43) and Stabilwax® (G16) GC columns, inlet liners, accessories, and applications you need at
About USP <467> Class 2 Residual Solvents:
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. This method identifies acceptable amounts of solvent residues that can be present, and the solvents are summarized by class according to their toxicity. 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 new standard reflects the changes made in USP <467> effective August 2013 and replaces Restek® cat.# 36271.