Purification process of ferric carboxymaltose
AssigneeRk Pharma Inc.
InventorsRavishanker Kovi, Jayaraman Kannapan, Hemant Mande, Rajesh Patel, Ritesh H Panchal, Varun L Zambare
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Abstract
The present application provides processes for the purification of ferric carboxymaltose, the process includes the steps of dissolving crude ferric carboxymaltose in a first solvent; charging the ferric carboxymaltose solution in a reaction vessel with a second solvent and precipitating therefrom a ferric carboxymaltose precipitate; and isolating pure ferric carboxymaltose from the ferric carboxymaltose precipitate.
Claims8
A process for the purification of ferric carboxymaltose, comprising:
- a. dissolving crude ferric carboxymaltose in a first solvent;
- wherein the crude ferric carboxymaltose and first solvent solution has a concentration of 0.20 g/ml to 0.33 g/ml;
- b. adding the ferric carboxymaltose solution obtained in step a to a reaction vessel that contains a second solvent and precipitating therefrom a ferric carboxymaltose precipitate;
- and
- c. isolating pure ferric carboxymaltose from the ferric carboxymaltose precipitate.
A process for the preparation of crude ferric carboxymaltose comprising:
- oxidizing aqueous solution of maltodextrin with sodium hypobromite, wherein concentration of aqueous solution of maltodextrin is 0.25 g/ml to 0.50 g/ml;
- and
- reacting the oxidized maltodextrin further with a ferric source therewith providing the crude ferric carboxymaltose.
Dependencies are inferred from the claim text.