Validation of quantitative method for determination of elemental impurities in pharmaceutical products following USP 232/233 on ICPMS-2030

Introduction

The 24 elemental impurities defined in USP<232> in three generic drug products were quantitatively determined on ICPMS-2030. A simple ICP-MS method that employs a single collision mode for all targeted elements is optimised and used. The sample preparation and method validation follow the USP<233> procedure strictly including both limit procedures and quantitative procedures.

April 2, 2020 GMT