Analysis of Residual Solvents - Class 1, Class 2A, Class 2B - in Pharmaceuticals Using Headspace-GC/MS

Introduction

Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. Residual solvents are classified and managed as Class 1 to Class 3 substances, depending on the risk they pose to human health. According to the USP, "General Chapter <467> Residual Solvents" method, analysis of these residual solvents is to be conducted by the headspace GC-FID method (HS- GC). However in this application, we investigated using headspace-GC/MS (HS-GC/MS) according to Procedure A. Using the HS-GC method, measurement is to be performed as three separate analyses, which are required to achieve chromatographic separation within the three different classes of compounds, Class 1, Class 2A, and Class 2B. However, using HS-GC/MS, complete chromatographic separation is not necessary, so all the compounds can be analyzed in a single run. In addition, compound confirmation and qualitative information of unknown peaks can also be obtained.

October 10, 2014 GMT