Analysis of Elemental Impurities in Pharmaceutical Products Following USP / on ICPMS-2030

Introduction

Elemental impurities contained in pharmaceutical products are getting more and more attention due to their harmful potential on patient health and impact on drug shelf life and efficacy. The United States Pharmacopeia (USP) has been continuously developing new guidelines in recent years to replace the over 100-year-old USP<231>. Heavy Metal Limit Test procedure using colorimetric method in USP<231> is no longer adequate for quantitation of elements at toxicology relevant levels. The new USP chapters for elemental impurities has been implemented since 1st January 2018. After harmonizing to ICH Q3D, the new USP<232> specifies impurities limits for 24 elements based on their toxicities. In USP<233>, two modern measuring techniques, ICP-OES and ICP-MS, are recommended together with the measuring and validation procedures. ICP-MS is indisputably considered as the best technique for determination of the heavy metals in pharmaceutical products at trace levels due to its high sensitivity, superior low detection limit, wide linearity range and multi-element analysis capability. In this application news we describe the ICP-MS analysis method and result of determining 24 elemental impurities in three different pharmaceutical products following USP<232> and USP<233> criteria on Shimadzu ICPMS-2030.

January 22, 2019 GMT