Analysis of Residual Solvents in Pharmaceuticals Using a He Alternative Carrier Gas
The United States Pharmacopeia (USP) General Chapter <467> on Residual Solvents provides test methods for residual solvents in pharmaceuticals, mainly using headspace gas chromatography (GC).
Helium (He) is generally used as the carrier gas, but analysis using an alternative carrier gas such as N2 or H2 has also been in demand, as He shortages and soaring prices have become an issue in recent years.
The following applications introduce a pharmacopeia-compliant analysis of Class 1 and 2 residual solvents using an alternative carrier gas..
Analysis using Nitrogen (N2) carrier gas
Analysis using Hydrogen (H2) carrier gas
In combination with a robust GC detector, the system can be used for quality control checks that require high quantitative accuracy. Traceability is guaranteed, with a simple function to leak check all samples as well as automatic audit trails.