Screening Analysis of 24 Elemental Impurity Elements in Drugs Using ICPMS-2040/2050

User Benefits

－Controlled elements can be verified by a screening analysis of 24 elemental impurity elements. －Use of the preset method in LabSolutions™ ICPMS makes it possible to begin the analysis simply without laborious study of conditions. －Study of candidate elements for internal standard correction is possible.

Introduction

The ICH Q3D Guideline for Elemental Impurities¹⁾ establishes permitted daily exposure (PDE) levels for 24 elements of toxicological concern. The elements that should be considered in risk assessments differ, depending on the administration route of the drug product. For oral preparations, only seven elements of Class 1 and 2A should be considered, except for the intentional addition of elements such as catalyst utilization during synthesis. However, the origins of contamination by elemental impurities are diverse, including not only the components of the drug substance and additives, but also manufacturing equipment and implements.

June 4, 2024 GMT