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Purpose <p>The 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.</p> Method <p>The 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.</p> Results <p>The 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.</p>

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Utilizing Octanoic Acid to Quantitatively Assess the Oxidation Status of PS80

  • 期刊论文

  • 发表日期：

    2025年8月11日

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  • Yue Guo,
  • Sisi Zhang,
  • Jamie Ash,
  • Stacey Helming,
  • Rachel Mullen,
  • Xuening Hu,
  • Qingyan Hu,
  • Jing Wang,
  • Tse-Hong Chen,
  • Shao-Chun Wang,
  • Douglas Kamen,
  • Biao Shen,
  • Hui Xiao,
  • Ning Li

摘要

Purpose

The 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.

Method

The 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.

Results

The 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.