Method for quantifying polysorbate in aqueous formulations

• Main Authors: BUSKER JAMES, K.BAUMGARTNER, MONARD DENIS, FRANK HEMMERLING, GARIDEL PATRICK
• Format: Patent
• Language: Chinese; English
• Published: 07.05.2024
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The present disclosure relates to a method (a) for quantifying polysorbate in an aqueous formulation containing polysorbate and one or more (poly) peptides, the method having the following steps: (a.1) providing a sample of the aqueous formulation; (a.2) adding a solution containing a fluorescent dye N-phenyl-1-naphthylamine to the sample of step (a.1) to obtain a fluorescent dye-containing sample to be tested in fluorescent micelle assay; (a.3) optionally incubating the sample containing the fluorescent dye of step (a.2); (a.4) carrying out fluorescent micelle determination on the sample containing the fluorescent dye obtained in step (a.2) or step (a.3); and (a.5) determining the content of polysorbate in the sample from the fluorescent micelle determination carried out in step (a.4), with the proviso that the method is performed without the use of an HPLC system. Additional methods (b) of the invention also allow for high throughput screening of large quantities of samples. The presence of the one or more