ANALYSIS OF POLYSORBATE 80 SOLUTION STABILITY UNDER STRESS CONDITIONS TO ENSURE ITS QUALITY AS A BIOPHARMACEUTICAL EXCIPIENT

Abstract

Objective: This study aimed to investigated the effect of light, temperature, pH, peroxides, trace metals, and buffer type on the chemical stability of polysorbate 80 (PS80) obtained from the three key manufactures. Methods: We used a fast liquid chromatography-evaporative light scattering detector that allowed the monitoring of PS80 decay over time. For data analysis, we investigated the change in the peak area percentage of the compound over time. Results: At pH 6.0 in histidine buffer, PS80-B was more sensitive than PS80-A and PS80-C. The PS80 from the three different sources degraded significantly with varying performance levels when exposed to light, temperature of 40 °C, peroxides, and trace metals over time. Conclusion: Our results provide an improved understanding of the stability of PS80 obtained from the three different sources under different conditions, which provides a basis for the selection of the appropriate grade of PS80 according to the specific requirements.