ArticlePharmaceutical research2025
Utilizing Octanoic Acid to Quantitatively Assess the Oxidation Status of PS80.
Article in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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Authors and funding
14 authors.
Funding
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Abstract
purposeThe study aims to address the gap in research concerning the stability of polysorbate (PS) in placebo samples, as opposed to drug products. While PS is a critical excipient in protein drug formulations, its stability in placebo samples has been less explored. Notably, PS in placebo samples is more susceptible to oxidation rather than hydrolysis, even at low temperatures like 5℃. The study seeks to provide a quantitative measure for PS oxidation, which has traditionally been described in vague terms.
methodThe research identified octanoic acid as an oxidative product of PS80, which can serve as a reliable marker for PS80 oxidation. This marker enables the detection of early signs of oxidation and facilitates a quantitative description of the oxidation status, regardless of the stress conditions and incubation times. The method's accuracy and precision were validated to be within 15%, aligning with industry standards.
resultsThe use of octanoic acid as a marker successfully indicates the oxidation status of PS80, offering a quantitative approach to assess PS80 stability. This method provides a clearer understanding of the shelf-life of placebo products concerning PS80 stability.
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Registered trials
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