Method and system for producing high purity vancomycin hydrochloride

摘要

A method is provided for preparing spray dried powder containing vancomycin hydrochloride. The method comprises providing a vancomycin hydrochloride solution with a chromatographic purity of at least 95%, adding an excipient to the vancomycin hydrochloride solution to form a mixture solution of the vancomycin hydrochloride solution and the excipient, concentrating the mixed solution of the vancomycin hydrochloride solution and the excipient to form a 20% to 30% vancomycin concentrate, filtering the vancomycin concentrate to form a final filtrate, and spray drying the final filtrate to form a spray dried vancomycin hydrochloride powder with EP impurity B level of not more than 1.5%.

主权项

1. A method for preparing a spray dried powder comprising vancomycin hydrochloride, the method comprising the steps of:
providing a vancomycin hydrochloride solution with a chromatographic purity of at least 95%; adding an excipient to the vancomycin hydrochloride solution to form a mixture solution of the vancomycin hydrochloride solution and the excipient; concentrating the mixture solution of the vancomycin hydrochloride solution and the excipient to form a concentrate comprising about 20% to 30% (w/v) vancomycin hydrochloride; filtering the vancomycin concentrate through at least one of a reverse osmosis membrane and a 200-800 Da nano-filtration membrane and controlling a temperature during filtering so that it does not exceed 20° C.; and spray drying the final filtrate to form a spray dried vancomycin hydrochloride powder with EP impurity B level of not more than 1.5%.