ICH Q3D Elemental Impurities Analysis of Drug Substances by EDX

Although ICP-AES/ICP-MS have been adopted as measurement instruments in USP <233>, in this experiment, validation was conducted using Energy Dispersive X-ray Fluorescence Spectrometer (EDX) as an alternative, referring to USP <735>, which provides the general analytical test method. In periodic tests and similar applications after validation, EDX enables simple measurement, even by nonexpert personnel, by introducing the sample into a dedicated container.
In this experiment, spiked samples for EDX were measured by using an ICP-MS in order to verify their appropriateness. The samples used here were drug substances (benazepril hydrochloride and captopril).