Comparing Peroxide Quantitation Assays: A Study on Peptide Drug Degradation

Peroxide mediated oxidation of drug molecule is a known challenge faced throughout the pharmaceutical development pathway - from early-stage stability studies to manufacturing processes. A control strategy for peroxide mitigation often becomes a critical quality attribute for the successful drug development. To this end, quantitation of peroxide is quintessential to monitor the peroxide level to ensure product quality and proposed shelf-life. However, it becomes challenging to have a reliable and robust quantitation method to detect trace levels of peroxide in complex drug product matrix. This talk will discuss three high-throughput assays based on absorbance, fluorescence and chemiluminescence to detect peroxide at low level, and compares the methods through validation studies in water. Selected methods were also tested to understand forced degradation of model peptide drug products with spiked hydrogen peroxide. Peptide degradation profiles and residual peroxide level were presented to understand the suitability of the quantitation methods and their performance.