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).

Content Type:
Application
Document Number:
LAAN-A-XR-E044
Product Type:
Elemental Analysis, Energy Dispersive X-ray Fluorescence Spectroscopy
Keywords:
EDX, ICP-MS, control of element impurities, ICH Q3D, drug product, maximum daily intake, drug substance, validation, Class 1, Class 2A, Class 2B, As, Hg, Pb, Cd, V, Co, Ni, Ir, Pt, Ru, Rh, Pd, Pharmaceutical, Life Science, EDX-7000
Language:
English
File Name:
jpq219010.pdf
File Size:
174kb

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