Method For Evaluating Degree Of Purity Of Pharmaceutical Substance Contained In Composite Body, And Method For Producing Composite Body

Abstract: Disclosed is a method that can evaluate the degree of purity of an active pharmaceutical substance contained in a composite body. Also disclosed is a method for producing a composite body in which the degree of purity of an active pharmaceutical substance itself is 95.0% or higher. The method for evaluating purity comprises: a reaction step for reacting, in a polar solvent, a nitrogen-containing nucleophilic agent, such as hydroxylamine, with a composite body in the presence of a protonic acid; and an evaluation step for evaluating, using rapid liquid chromatography, the degree of purity of a reaction mixture obtained in the reaction step. The method for producing a composite body comprises a reaction step for obtaining a composite body by reacting, in a polar solvent, N-(2-hydroxypropyl)methacrylamide polymer with an anthracycline pharmaceutical substance, in the presence of a protonic acid and at 10°C or lower.

Patent Information

Applicants

Inventors

Specification

Documents

Application Documents