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Evaluation of Oxidative Stress in Biological Samples Using the Thiobarbituric Acid Reactive Substances Assay
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Utilizing Octanoic Acid to Quantitatively Assess the Oxidation Status of PS80
Yue Guo1, Sisi Zhang1, Jamie Ash2
1Analytical Chemistry, Regeneron Pharmaceuticals, Tarrytown, NY, USA.
Pharmaceutical Research
|August 12, 2025
Summary
Polysorbate 80 (PS80) oxidation in placebo samples is quantified using octanoic acid as a marker. This method enhances understanding of PS80 stability and shelf-life in pharmaceutical formulations.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
Background:
- Polysorbate (PS) is a crucial excipient in protein drug formulations.
- PS stability in placebo samples is less understood than in drug products.
- PS in placebo is prone to oxidation, even at low temperatures.
Purpose of the Study:
- To address the research gap on polysorbate stability in placebo samples.
- To develop a quantitative measure for polysorbate oxidation.
- To investigate polysorbate oxidation susceptibility in placebo formulations.
Main Methods:
- Identified octanoic acid as an oxidative product of polysorbate 80 (PS80).
- Utilized octanoic acid as a marker for quantitative assessment of PS80 oxidation.
- Validated method accuracy and precision within 15%.
Main Results:
- Octanoic acid reliably indicates PS80 oxidation status.
- Quantitative assessment of PS80 stability is now possible.
- Improved understanding of PS80 shelf-life in placebo products.
Conclusions:
- Octanoic acid serves as a robust marker for PS80 oxidation.
- The developed method enables quantitative evaluation of PS80 stability.
- This research clarifies PS80 behavior in placebo formulations.
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