G326-Analysis of Residual Solvents in Pharmaceuticals by Water-Insoluble Samples Using N2 Carrier

The Japanese Pharmacopoeia 17th Edition (JP17) and the 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 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.

Content Type:
Application News
Document Number:
G326
Product Type:
Gas Chromatography (GC)
Keywords:
residual solvents, water-insoluble, n2 carrier gas, jp17, usp267, Pharma & Biopharma, QA/QC Manufacturing, GC-2030
File Name:
G326-residual-solvents-pharmaceuticals-water-insoluble-gc2030.pdf
File Size:
137kb

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

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