Analysis of Residual Solvents in Pharmaceuticals by Nexis™ GC-2030 + HS-20 (JP17 Supplement II, USP 467)

Introduction

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 and are strictly controlled. The list of residual solvents is continuously reviewed and methylisobutylketone (MIBK) has been newly added to JP17 Supplement II in 2019. The compound is classified as Class 2 mixture A standard solution (Class 2A) in the USP. In this article, MIBK was analyzed and its chromatogram was overlaid with that of Class 2A as a reference.

June 25, 2023 GMT