Characterizing Lot-to-lot Differences in Polysorbate Samples with Universal HPLC Detection

Overview:

Impurities and lot-to-lot variability in non-UV chromophore-containing excipients and surfactants can lead to significant issues for the development of a pharmaceutical preparation. In this study, a universal HPLC detection technology, charged aerosol detection, is used to easily and clearly differentiate and identify lot-to-lot variances in a series of polysorbate preparations. Utilizing CAD technology provides laboratories with a powerful new tool in analytical capabilities for these difficult to analyze polydisperse, heterogeneous mixtures.