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Stability evaluation from hydrogen peroxide spiking studies

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2024

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European Journal of Pharmaceutical Sciences. Elsevier. 2024, 203, 106916. ISSN 0928-0987. eISSN 1879-0720. Verfügbar unter: doi: 10.1016/j.ejps.2024.106916

Zusammenfassung

The ability to detect traces of hydrogen peroxide (H2O2) in water is an important prerequisite to ensure a safe and reliable use of H2O2 for isolator or cleanroom sanitization. While the residual airborne H2O2 concentration can be easily monitored, detection of trace H2O2 residues in aseptically filled drug products is challenging. In an industrial setting, samples must be pulled, handled, stored, and transported before analysis takes place. Therefore, knowledge about the analyte stability in the relevant matrix is crucial to ensure correct results.

The objective of this study was to provide stability data for the analyte at low concentrations and in aqueous solutions. For this, H2O2 was spiked into four different aqueous matrices at two different concentrations and stored up to 60 days at four different storage temperatures. The tested matrices included water, buffer, and an exemplary excipient solution with and without additional protein.

A developmental quantitative, fluorometric Amplex UltraRed assay was applied for analysis. The results show clearly, that of the four storage temperatures investigated, only -80 °C resulted in reasonably good recovery of the spiked H2O2 content within two weeks or even up to two months of storage.

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Fachgebiet (DDC)
570 Biowissenschaften, Biologie

Schlagwörter

Hydrogen peroxide, VHP, Amplex UltraRed, Analyte stability, H2O2, WfI

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ISO 690HEUSSNER, Alexandra H., Marlene HERMANN, Melanie ZERULLA-WERNITZ, 2024. Stability evaluation from hydrogen peroxide spiking studies. In: European Journal of Pharmaceutical Sciences. Elsevier. 2024, 203, 106916. ISSN 0928-0987. eISSN 1879-0720. Verfügbar unter: doi: 10.1016/j.ejps.2024.106916
BibTex
@article{Heussner2024-12Stabi-71230,
  year={2024},
  doi={10.1016/j.ejps.2024.106916},
  title={Stability evaluation from hydrogen peroxide spiking studies},
  volume={203},
  issn={0928-0987},
  journal={European Journal of Pharmaceutical Sciences},
  author={Heussner, Alexandra H. and Hermann, Marlene and Zerulla-Wernitz, Melanie},
  note={Article Number: 106916}
}
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A developmental quantitative, fluorometric Amplex UltraRed assay was applied for analysis. The results show clearly, that of the four storage temperatures investigated, only -80 °C resulted in reasonably good recovery of the spiked H&lt;sub&gt;2&lt;/sub&gt;O&lt;sub&gt;2&lt;/sub&gt; content within two weeks or even up to two months of storage.</dcterms:abstract>
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