Residual Solvents Solutions
Revised USP 467 Residual Solvent Method - Satisfy New Method Requirements with Restek Columns and Standards
The United States Pharmacopeia recently revised the general chapter on residual solvent analysis, USP <467>, to mirror the International Conference on Harmonization (ICH) guidelines for the identification, control and quantification of residual solvents. This revision, effective July 1, 2007, replaces previous methods that were not consistent with the ICH guidelines. Here we provide an overview, chromatograms, and technical tips for successfully running the new procedure.
To make column selection for residual solvents easy, Restek has benchmarked the ICH Class 1, 2 and 3 residual solvents on our most popular OVI columns.
Single-injection, dual-column detection/confirmation assay is feasible for regulated solvents in pharmaceutical products, but no temperature program provides sufficient resolution on both columns. Using a Restek G43/G16 column pair and independent temperature programs in a Gerstel MACH column heating system, we analyzed and confirmed 23 Class 2 solvents in 8 minutes.
Static headspace analysis will save you time and money when assaying a variety of sample matrices—and often is easier than alternative sampling approaches. This 20-page guide discusses basic principles, instrumentation, applications, and troubleshooting. Restek capillary GC columns and an extensive selection of accessories will simplify getting started.
This 12-page reference includes a of headspace fundamentals, the revised USP <467> method (July, 2008), chromatography for Procedures A, B, and C, and technical tips for optimization. Guidance on fast, effect method development is given.