This application note demonstrates the excellent performance of the Varian 450-GC Gas Chromatograph/CombiPAL headspace system in the analysis of some Class 1 and Class 2 solvents under USP <467>.
This document is an application note detailing the performance of the Varian 450-GC Gas Chromatograph combined with the CombiPAL headspace sampler. It specifically demonstrates the system's ability to meet the requirements of USP <467> for the determination of residual solvents in pharmaceutical products. The note covers the analysis of Class 1 and Class 2 solvents using specific column configurations.
| Carrier Gas | Helium, constant flow |
|---|---|
| Flow Rate | 2.0 mL/min |
| Injector Temperature | 140 °C |
| Detection Method | FID |
| Software | Galaxie™ Software |
| Column A (Procedure A) | VF-624ms, 30 m x 0.32 mm, df = 1.80 μm |
| Column B (Procedure B) | VF-WAXms, 30 m x 0.32 mm, df = 0.25 μm |
The minimum requirement is a Signal-to-noise (S/N) ratio > 3.
The minimum required signal-to-noise ratio for Class 1 chemicals in Procedure A is greater than 3.
The required resolution for the acetonitrile/dichloromethane separation in Procedure A is greater than 1.0.
The required resolution for the acetonitrile/cis-dichloroethene separation in Procedure B is greater than 1.0.