Methods For Measuring Levels Of Polysorbate(s)

Abstract: The disclosure provides methods for measuring polysorbate levels in a sample. The method comprises applying an aliquot of the sample onto a high-performance liquid chromatography system with a mixed-mode column, eluting the sample with a gradient from a first mobile phase to a second mobile phase, and applying evaporative light-scattering detection to the eluant as it exits the column, thereby measuring polysorbate levels. The first mobile phase comprises 0-20% of an acid, 1-70% acetonitrile, methanol, tetrahydrofuran, tetrahydrofuran, isopropyl alcohol, or mixtures thereof, and water. The second mobile phase comprises 0-20% of an acid, 80-100% acetonitrile, methanol, tetrahydrofuran, tetrahydrofuran, isopropyl alcohol, or mixtures thereof, and optionally water.

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