PerkinElmer
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Application Brief

Iron Sucrose Injection Assay by HPLC in Accordance with the USP

Introduction

Iron sucrose injection is a sterile, colloidal solution of ferric hydroxide in complex with sucrose in water for injection. It is used to treat iron-deficiency anemia (too little iron resulting in a reduced number of red blood cells) in those with chronic kidney disease. The drug is in a class of medications called iron replacement products and acts to replenish iron stores, allowing the human body to produce more red blood cells. Iron sucrose injection contains NLT 95.0% and NMT 105.0% of the labeled amount of iron. It contains no antimicrobial agent, chelating agent, dextran, gluconate, or other added substances. This application brief describes the use of a Quasar Amino column (L8 packing) for the analysis of iron sucrose injection in accordance with the official USP monograph.