Analysis of ICH Q3D Guideline for Elemental Impurities in Drug Products Using ICPMS-2030

Introduction

The ICH Q3D Guideline for Elemental Impurities sets permitted daily exposures (PDEs) for 24 elemental metal impurities of which toxicity is a concern, including the so-called big four (lead (Pb), cadmium (Cd), mercury (Hg), and arsenic (As)), and residual catalyst metals that are added intentionally during active pharmaceutical ingredient synthesis. Table 1 shows the ICH Q3D guideline of PDE for elemental impurities. The PDE levels shown for metal impurities must be converted to concentrations in order to evaluate the presence of metal impurities in drug products and their components. We describe an example of analysis of 24 elements included in the ICH Q3D guideline using inductively coupled plasma mass spectrometry.

September 20, 2016 GMT