Method and system for producing high purity vancomycin hydrochloride
OwnerChoon Teo, Xianqiang Sun +1inventors
InventorsChoon Teo, Xianqiang Sun, Xiaoyong Wang
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Abstract
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%.
Claims14
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%.
Dependencies are inferred from the claim text.