Hydrolytic polysorbate 20 degradation – Sensitive detection of free fatty acids in biopharmaceuticals via UPLC-QDa analytics with isolator column

Dirk-H Evers,Stefan Carle,Daniel Lakatos, Frank Hämmerling,Patrick Garidel,Julia Buske

Journal of Chromatography B（2021）

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摘要

•UPLC-QDa method to quantify fatty acids in biologics containing polysorbate 20.•Determine fatty acid concentrations via polysorbate CoA and laurate calibration.•Case studies: three biologics induce specific fatty acid release patterns over time.

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关键词

Polysorbate,Fatty acids,Label-free quantification,Absolute quantification in ng/mL,UPLC,QDa,Isolator column

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