Analysis of Residual Solvents in Pharmaceutical Products by Headspace-GC-FID with Nitrogen Carrier Gas Following USP- Procedure B

Introduction

USP <467> monograph describes Procedure A and B for analysing residual solvents in pharmaceutical products by Headspace Gas Chromatography (HSGC) [1]. Procedure A is the main method, while Procedure B is to be carried out as verification when certain criteria is not met in Procedure A result. In Application News AD-0209, analysis of residual solvents in pharmaceutical products was done following Procedure A which was performed using nitrogen carrier gas, an inexpensive and abundant alternative to helium [2]. Here, we describe HS-GC method using nitrogen as the carrier gas to analyse Class 1 and Class 2 solvents following USP<467> Procedure B criteria.

August 26, 2020 GMT