Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 157, Issue -, Pages 201-207Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jpba.2018.05.031
Keywords
Biopharmaceutical formulations; Polysorbate 20; Oxidative degradation; Fatty acid esters; 2,4-Dinitrophenylhydrazine; Reverse phase ultra high performance liquid chromatography
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Polysorbates can undergo oxidative degradation in pharmaceutical formulations resulting in both soluble and insoluble degradation products. The insoluble degradants may precipitate to form subvisible and visible particulates, which are undesirable in liquid parenteral products. To date, no oxidation byproduct has been identified as an established marker to track Polysorbate 20 oxidation. Herein, we identified the aldehyde derivative of free fatty acid esters as a byproduct of polysorbate oxidation that can be derivatized using 2,4-dinitrophenylhydrazine and tracked analytically to monitor oxidative polysorbate degradation in pharmaceutical formulations. (C) 2018 Elsevier B.V. All rights reserved.
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