Analysis of Residual Solvents in Pharmaceuticals by Water-Soluble Samples Using N2 Carrier

United States Pharmacopeia (USP) General Chapters <467> Residual Solvents provide test methods for residual solvents in pharmaceuticals mainly using headspace gas chromatography (GC). 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 as He supply shortages have become an issue recently, analysis using an alternative carrier gas such as N2 has also been in demand lately. This article introduces a JP17 Supplement II- compliant analysis of water-soluble samples for Class 1 and 2 residual solvents using N2 as the carrier gas.

Content Type:
Application News
Document Number:
G325
Product Type:
Gas Chromatography (GC)
Keywords:
residual solvents, pharmaceuticals, water-soluble, n2 carrier, jp17, usp 467, Pharma & Biopharma, QA/QC Manufacturing, GC-2030
Language:
English
File Name:
G325-residual-solvents-pharmaceuticals-water-soluble-gc2030.pdf
File Size:
148kb

View Article

For Research Use Only. Not for use in diagnostic procedures.

Top of This Page