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

Authors

  • ZHUAN CHENG WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131 https://orcid.org/0000-0003-4866-8766
  • XIAOHUI WANG WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131 https://orcid.org/0000-0002-2736-8679
  • QUANMIN CHEN WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131
  • JEREMY GUO WuXi Biologics, 299 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, 200131 https://orcid.org/0000-0002-2497-9642

DOI:

https://doi.org/10.22159/ijap.2022v14i4.44708

Keywords:

: HPLC (high-performance/pressure liquid chromatography); surfactants; excipients; stability; oxidation; hydrolysis; degradation product(s); proteins formulation; analytical chemistry; pH

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.

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Published

28-05-2022

How to Cite

CHENG, Z., WANG, X., CHEN, Q., & GUO, J. (2022). ANALYSIS OF POLYSORBATE 80 SOLUTION STABILITY UNDER STRESS CONDITIONS TO ENSURE ITS QUALITY AS A BIOPHARMACEUTICAL EXCIPIENT. International Journal of Applied Pharmaceutics, 14(4). https://doi.org/10.22159/ijap.2022v14i4.44708

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