ICH Q3D Elemental Impurities Analysis of Tablets by EDX - Verification Based on USP ELEMENTAL IMPURITIES-PROCEDURES -

Introduction

In the United States, the United States Pharmacopoeia General Test Chapters USP <232> and <233> have been applied to new drug products since January 1, 2018. ICP-MS and ICP-AES are recommended as the analysis procedures in the chapters. However, if the validation requirements are met, the alternative procedure can be substituted for the recommended analysis procedures. Therefore, the appropriateness of Energy Dispersive X-ray Fluorescence Spectrometer was verified referring to “Limit Procedures” in USP <233>^*1. The used instrument was EDX-7000 and the test was conducted by evaluating of elemental impurities in oral drug. As the target concentration (allowable concentration), the value obtained by dividing 30% of the PDE^*2 value by the maximum daily dose was set. *1 Since the measurement sample in EDX is ’’Powder’’, the ’’Solution’’ part described in the test method was replaced with 'powder' *2 PDE: Permitted Daily Exposure

March 30, 2020 GMT