Analysis of Residual Solvents in Pharmaceuticals An Analysis Method for Class 2 Solvents (Water-Soluble Samples) Unsuited to Headspace GC Methods

Introduction

Testing methods for residual solvents in pharmaceuticals are defined in the Japanese Pharmacopoeia Seventeenth Edition and USP (U.S. Pharmacopeia), General Chapters <467> Residual Solvents. While these testing methods mainly describe the detailed testing procedures for Class 1 and Class 2 residual solvents using headspace GC methods, there is no mention of testing methods for solvents possibly used in the testing of compounds and water-insoluble pharmaceuticals, which are unsuited to headspace analysis. This article presents an analysis and examination of the water- soluble samples listed in Table 1, "Solvents Possibly Used in the Testing of Compounds and Water-Insoluble Pharmaceuticals Unsuited to Headspace Analysis (Class 2C)."

June 25, 2023 GMT