Stability evaluation from hydrogen peroxide spiking studies
Year: 2024
Type: article
Abstract: The ability to detect traces of hydrogen peroxide (H 2 O 2 ) in water is an important prerequisite to ensure a safe and reliable use of H 2 O 2 for isolator or cleanroom sanitization. While the residual airborne H 2 O 2 concentration can be easily monitored, detection of trace H 2 O 2 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, H 2 O 2 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 H 2 O 2 content within two weeks or even up to two months of storage.
Institution: Vetter (Germany)
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
Estimated APC paid: $2,700
OpenAlex ID: W4402905385