Analysis of Residual Solvents in Pharmaceuticals by Water-Insoluble Samples Using N2 Carrier (JP17 Supplement II, USP 467)

Residual solvents in pharmaceuticals are classified from Class 1 to 3 based on their potential human health risk. Since these compounds are strictly controlled, highly sensitive analysis is required. Helium (He) is generally used as the carrier gas, but analysis using an alternative carrier gas such as N2 has also been in demand recently as He supply shortages have become an issue in recent years.
This article introduces a JP17 Supplement II-compliant analysis of water-insoluble samples for Class 1 and 2 residual solvents using N2 as the carrier gas.