Validation of Analysis Method Using ICPMS-2030 Based on USP ELEMENTAL IMPURITIES - PROCEDURES

Introduction

The Guideline for Elemental Impurities ICH Q3D (1) was setting the Permitted Daily Exposures (PDEs) for 24 elements with toxicity risk issues, and required control of their contents by an appropriate testing method. In the United States Pharmacopeia General Chapters USP <233> (2), inductively coupled plasmamass spectrometry (ICP-MS) is recommended as the analysis procedures. In this paper, the validation of the analytical method using a Shimadzu ICPMS-2030 was carried out in accordance with USP <233>. The tested materials were constituent ingredients used in oral formulations. The accuracy, precision, limit of quantitation and specificity of 24 target elements are presented, assuming measurements below the Control Threshold, 30% of the PDE.

May 11, 2020 GMT