The document introduces a method for determining residual solvents in pharmaceuticals using Agilent G1888 Network Headspace Sampler.
The document describes an analytical method for determining Class 1 and Class 2 residual solvents in pharmaceutical products. It utilizes the Agilent G1888A Network Headspace Sampler coupled with a 6890N Gas Chromatograph configured with either a Flame Ionization Detector (FID) or a 5973 inert Mass Selective Detector (MSD). The method employs static headspace sampling to analyze solvents listed in USP 467 and International Conference on Harmonization (ICH) guidelines.
| Sample Loop Size | 1-mL |
|---|---|
| Split Ratio (Recommended) | 2:1 to 5:1 |
| Detector Temperature (FID) | 260 °C |
| Headspace Oven Temperature | 85°C |
The analysis covers Class 1 and Class 2 solvents according to ICH guidelines, as well as those listed in USP 467.
While normally set at 60 minutes, a 30-minute equilibration time is sufficient for most cases.