METHOD FOR RAPID DETERMINATION OF WATER CONTENT IN HUMAN COAGULATION FACTOR VIII FINAL PRODUCT

摘要

Disclosed is a method for rapid determination of the water content in a human coagulation factor VIII final product, comprising the following steps of: (1) preparing human coagulation factor VIII preparation products with different water contents; (2) using a near-infrared spectrometer to collect a near infrared spectrum directly, and determining the water content in a sample; (3) dividing sample sets of different water contents, to obtain a calibration set for establishing a model and a validation set for validating the ability of a model to carry out prediction; (4) comparing evaluation parameters of models under different pretreatment methods and model wavelengths to obtain an optimal pretreatment method and model wavelength, so as to establish a PLS quantitative analysis model for determining the water content; (5) taking a sample to be tested, collecting a near infrared spectrum, fitting the spectrum obtained against a model, and obtaining the water content value in a human coagulation factor VIII preparation product. The method is simple and practicable, quick and non-destructive, green and environmentally friendly, and in particular, is suitable for determining the water content in a lyophilized human coagulation factor VIII lyophilized product.