FIELD: analytical chemistry.
SUBSTANCE: following is disclosed: a method of quantifying at least one polysorbate or polysorbate oxidation and/or hydrolysis product in a sample, comprising the step of performing an LC-MS analysis of the said sample based on a dioxolanilium ion signal and the step of performing an internal calibration using an internal standard of the said polysorbate. Also a method of monitoring the degradation of at least one polysorbate in a sample is disclosed.
EFFECT: group of inventions provides an effective and reliable method that allows to perform the quantitative determination of polysorbates in a single analysis.
13 cl, 10 dwg, 2 tbl, 1 ex
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Authors
Dates
2023-10-20—Published
2020-02-27—Filed