COMPOSITION FOR DETERMINING THE CONTENT OF IGA IMMUNOGLOBULINS IN MEDICINAL PRODUCTS Russian patent published in 2023 - IPC A61K39/395 A61K35/16 

FIELD: pharmaceutical industry.

SUBSTANCE: group of inventions relates to a composition for determining the content of IgA impurity in human immunoglobulin medicinal preparations, a method for its preparation and use, as well as a kit for determining the content of IgA immunoglobulin impurity in human immunoglobulin medicinal preparations. The composition for determining the content of IgA immunoglobulin impurities in human immunoglobulin preparations includes human blood serum with an optical density of 0.200, containing 58 g/ml of a stable protein, which includes a certified amount of IgA immunoglobulins from 1.736 to 2.224 mg/ml. The method for preparing the composition includes obtaining a pooled selected human blood plasma containing a solution of calcium chloride, followed by centrifugation to obtain human blood serum under certain conditions. Also claimed is a kit for determining the content of IgA immunoglobulin impurities in human immunoglobulin medicinal preparations, which has a certain composition. The claimed composition is used to determine the content of IgA immunoglobulin impurities in human immunoglobulin medicinal preparations as a standard sample.

EFFECT: above composition makes it possible to obtain a pharmaceutical composition for determining the content of class A (IgA) impurities in human immunoglobulin medicinal preparations, certified in relation to the International Reference Standard, by methods of radial immunodiffusion, kinetic nephelometry and enzyme immunoassay applicable for quantitative determination of the content of IgA impurity by the three indicated methods and to conduct validation studies of these methods.

14 cl, 17 tbl, 8 ex