June 10, 2022
Polysorbates are widely used excipients in biotherapeutic formulations that may degrade and thus affect the quality, efficacy, safety, and stability of biopharmaceuticals. Regulatory interest in excipient sourcing and stability has increased recently. By delivering information-rich data at the molecular level, MS offers a powerful approach to overcome the challenges of analyzing these complex, heterogeneous molecules. However, the highly complex MS data obtained from samples containing polysorbates typically requires laborious and time-consuming expert analysis.
Here we present a method for the detailed analysis of PS-80 components using Reversed-Phase Ultra High-Performance Liquid Chromatography coupled with High Resolution Mass Spectrometry (RP-UHPLC-HRMS) utilizing post-column charge reduction and a dedicated software workflow for an uncompromising increase in robustness and reduction in analysis time.