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.
This 12-page reference includes a review 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. (PDF - 471kB)
Develop impurity methods faster and more efficiently using a single column that combines the selectivity of a 624 with the thermal stability of a 1 or 5 type column. The new Rxi®-624Sil MS column offers good retention of polar compounds, mass spec compatibility, and unsurpassed inertness, making it the most broadly applicable GC column available to the pharmaceutical industry. (PDF - 1058kB)
