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

Introduction

The Japanese Pharmacopoeia 18th Edition (JP18) and the United States Pharmacopeia (USP) General Chapter <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. Any method changes, such as substituting He with an alternate carrier gas, must be validated according to USP General Chapter <1467> Residual Solvents—Verification of Compendial Procedures and Validation of Alternative Procedures. This article introduces a JP18- compliant analysis of water- soluble samples for Class 1 and 2 residual solvents using N₂ as the carrier gas.

June 25, 2023 GMT