Development and Qualification of an Assay Method for Deferoxamine Mesylate and p-SCN-DFO Volume 5 - Issue 3

Paul Jurek¹*, Montgomery M Martensen¹, A Eli De Lira¹, and Garry E Kiefer¹

• ¹Macrocyclics, Inc. An Orano Med Company, 700 Klein Rd, Plano, TX 75074, United States

Received:June 4, 2021   Published:June 15, 2021

*Corresponding author:Paul Jurek, Director of Custom Product Development, Macrocyclics, Inc an Orano Med Company, 700 Klein Rd, Plano, TX 75074, United States

DOI: 10.32474/AOICS.2021.05.000211

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Abstract

A simple, colorimetric assay method has been developed for deferoxamine mesylate and a related bifunctional chelating agent, p-SCN-DFO. A classic back-titration is performed where an excess amount of a standardized zirconium solution is added to the chelating agent solution. The excess zirconium is then titrated with standard EDTA. A qualification study was undertaken to evaluate the integrity of the method. Accuracy, specificity, and precision were evaluated and found to be excellent. The method is traced back to an analytical primary standard thus avoiding the need to create and use compound-specific reference standards.

Keywords:Zirconium; assay; p-SCN-DFO; titration; deferoxamine

Abstract| Introduction| Materials and Methods| Results and Discussion| Conclusions| References|