Analysis of Residual Solvents in drug products using Nexis GC-2030 combined with HS-20 head space sampler

Introduction

Residual solvents in pharmaceuticals are defined as volatile organic compounds used in or generated from the manufacture of drug substances, pharmaceutical additives, or drug products. They are strictly controlled according to risk classifications from Class 1 to Class 3, which are based on the risk to human health. Headspace GC methods specified in the USP (U.S. Pharmacopeia), General Chapters <467> Residual Solvents, are commonly used for analysis of residual solvents. This Application News presents data obtained using the Shimadzu HS-20 Headspace Sampler and Nexis GC-2030 Gas Chromatograph, from Class 1 and Class 2 standard solutions, in accordance with Water- Soluble Articles, Procedure A, in USP <467> Residual Solvents.

June 25, 2023 GMT