Stability evaluation from hydrogen peroxide spiking studies

Abstract

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.