METHOD FOR DETERMINING A CONCENTRATION OF A POLYSORBATE SPECIES IN A MIXTURE

摘要

The present invention relates to a method of measuring polysorbates, such as polysorbate 80, using Attenuated Total Reflectance-Fourier Transform Infrared spectroscopy (ATR-FTIR).

主权项

1. A method for determining the concentration of a polysorbate species in a mixture, comprising:
a) obtaining a test sample of said mixture; b) adding an internal standard to said test sample; c) obtaining, with a spectrometer, a mid-infrared Attenuated Total Reflectance (ATR) spectra of the test sample; d) identifying, from the reflectance spectra, a wavenumber corresponding to the C═O peak; e) identifying, from the reflectance spectra, a wavenumber corresponding to the internal standard; f) calculating the area under the curve for said C═O wavenumber, normalized by the internal standard; and g) comparing said area to a calibration curve to determine the concentration of polysorbate in said test sample.