Monitoring polysorbate hydrolysis in pharmaceutical formulations using an ultrasensitive extraction-free fatty acid quantitation method
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsSisi ZHANG, Hui Xiao, Ning Li
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Abstract
The present invention generally pertains to methods of quantifying free fatty acids in a pharmaceutical formulation. In particular, the present invention pertains to a method of quantifying free fatty acids released from polysorbate hydrolysis in a pharmaceutical formulation comprising a pharmaceutical product, polysorbate and free fatty acids, using liquid chromatography-mass spectrometry, without the use of an extraction step.
Claims26
A method for quantifying free fatty acids in a pharmaceutical formulation comprising an antibody, polysorbate, and free fatty acids, the method comprising:
- (a) incubating said pharmaceutical formulation;
- (b) subjecting said formulation to liquid chromatography to separate said free fatty acids;
- and
- (c) using a mass spectrometer to quantify said free fatty acids,
- wherein said free fatty acids are not extracted from said formulation prior to subjecting said formulation to liquid chromatography.
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Dependencies are inferred from the claim text.