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Solution Stability of Polysorbate 80 Under Stress Conditions
  • Zhuan Cheng
Zhuan Cheng
WuXi Biologics

Corresponding Author:[email protected]

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Abstract

Polysorbate 80 (PS80) is a nonionic surfactants which is widely used in the development of protein pharmaceuticals. Due to their chemical structure, polysorbates are prone to degradation by oxidation and hydrolysis, which can render a pharmaceutical product instable or incompliant. In this study, we have investigated the chemical stability of PS80 purchased from different manufacturers as a function of light, pH, peroxides, trace metals and buffer type. For this purpose, a fast liquid chromatography-evaporative light scattering detector (LC-ELSD) detection method was developed which allows (1) to differentiate between hydrolytic and oxidative PS80 degradation and (2) to monitor the PS80 decay over time. According to the method, we analyzed the differences in the 6 main classes of PS80 subspecies purchased from three manufacturers and also analyzed the change of their area percent over time. The study showed that PS80 is relatively more stable under the condition of basic hydrolysis within 3 months. However, under histidine-buffer, pH6.0, the PS80 of manufacture B(PS80-B) is more sensitive than manufacture A (PS80-A) and manufacture C(PS80-C). The PS80 of three manufactures degraded under exposure to light, peroxides and trace metals over the time. The performance of PS80 of three different manufacturers was different.