ICH Q3D Elemental Impurities Analysis of Drug Substances by EDX

Introduction

The ICH Harmonised Guideline, Guideline for Elemental Impurities (ICH Q3D) of drug products, requires control of the residual amounts of 24 elements whose toxicity is a concern. This requirement was applied to new drug products from June 2016 in the United States and Europe and from April 2017 in Japan. Application to existing drugs began in January 2018 in the United States and in December 2017 in Europe. Although the recommended analytical methods for elemental impurities are inductively coupled plasma-atomic emission spectrometry (ICP-AES) and ICP-mass spectrometry (ICP-MS), use of appropriate alternative methods is also permitted when such methods exist. Therefore, the appropriateness of X-ray fluorescence spectrometry as an alternative to the above- mentioned methods was verified referring to the United States Pharmacopeia USP <735>. The instrument used was an EDX-7000 and its option, “Pharmaceuticals Impurities Analysis Method Package.” Quantitative analysis was done by the calibration curve method with standard sample aqueous solutions using two types of drug substance in powder form as the test materials. The results were satisfactory, confirming the possibility of using EDX in control of elemental impurities of drug products.

October 30, 2019 GMT