Measuring Elemental Impurities in Pharmaceuticals ― A Practical Guide

A dedicated guide for the pharmaceutical/nutraceutical QA/QC communities about the new USP Chapters covering metal impurities. It describes the requirements of the new chapters and gives an overview of why the new rules are needed. The fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice in the pharmaceutical and nutraceutical industries will find easy to understand. It includes easy-to-read chapters on hardware components, calibration protocols, typical interferences, routine maintenance and trouble-shooting procedures. Similar guidelines being proposed by the ICH will also be included.

Robert J. Thomas has worked in the field of trace element analysis for over 40 years, including 24 years for an ICP-MS manufacturer and 15 years as a principal of his own consulting company. He has served on the ACS (American Chemical Society) Reagent Chemical Committee for the past 17 years as leader of the elemental impurities task force where he has worked closely with the USP to align heavy metal testing procedures in analytical reagents with those of pharmaceutical materials. He has authored almost 100 publications on trace element analysis and written three textbooks on ICP-MS and related topics, including this new book, which focuses on the new global directives on elemental impurities in pharmaceutical materials and dietary supplements. He is currently editor and frequent contributor to the Atomic Perspectives Column in Spectroscopy Magazine. He has a graduate degree in Analytical Chemistry from the University of Wales in the UK and is a Fellow of the Royal Society of Chemistry (FRSC, and a Chartered Chemist (CChem