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 watersoluble
samples listed in Table 1, "Solvents Possibly Used in the
Testing of Compounds and Water-Insoluble Pharmaceuticals
Unsuited to Headspace Analysis (Class 2C)."