Residual Solvent Analysis in Pharmaceuticals with N₂ Carrier Gas Using Nexis GC-2060 and HS-20 NX — JP 18 and USP <467> / Water-Soluble Samples —

User Benefits

- The newly designed FID delivers outstanding sensitivity, ensuring highly accurate and reliable analysis. - Achieve full compliance with JP and USP guidelines using N₂ carrier gas, which is highly affordable and readily available. - Easily analyzes tert-butyl alcohol and Cyclopentyl methyl ether, the Class 2 solvents added in the ICH Q3C (R8) guideline.

Introduction

For the analysis of residual solvents in pharmaceuticals, headspace gas chromatography (HS-GC) is widely used to target Class 1 and Class 2 solvents, in accordance with USP General Chapter <467> and JP18 (Japanese Pharmacopoeia, 18th Edition). These regulatory tests demand high sensitivity and reproducibility. The newly developed FID for the Nexis GC-2060 offers superior detection sensitivity compared to conventional models, enabling highly sensitive analysis. Additionally, due to recent helium supply shortages and rising costs, there is a growing demand for alternative analysis using nitrogen (N₂) as a carrier gas. This application note presents the analysis of Class 1 and Class 2 water-soluble samples using the Nexis GC-2060 with N₂ carrier gas, compliant with Supplement II to the Japanese Pharmacopoeia. DMSO was used as the sample solvent.

August 3, 2026 GMT