Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability. This article reviews a two-method approach using high-performance liquid chromatography (HPLC) and charged aerosol detection (CAD) to detect degradation and differences in chemical composition in treated samples.
Characterization of trace elements is important for upstream process development and batch quality control. In this poster, Catalent Biologics outlines a strategy using inductively coupled plasma-mass spectrometry (ICP-MS) to conduct trace-level multiple analysis.
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