[Case Study] Analysis of Residual Solvents in Pharmaceuticals Using Headspace GC

A time-saving analytical method using nitrogen carriers as a measure to address helium shortages.

Organic solvents are often used in the manufacturing and purification of active pharmaceutical ingredients, but due to their potential toxicity, it is necessary to verify whether they are present in pharmaceuticals to ensure patient safety. The United States Pharmacopeia (USP) method <467> provides detailed procedures for the screening, confirmation, and quantification of residual solvents, including sample preparation and analytical conditions. Gas chromatography (GC) combined with headspace (HS) sampling technology and a hydrogen flame ionization detector (FID) is an analytical method specified in USP <467>, where most target compounds are organic solvents with relatively low boiling points and good thermal stability. This technical note presents a rapid and cost-effective analysis of residual solvents using nitrogen as the carrier gas.

Analytical Equipment and Devices