Paricalcitol purification
AssigneeAlphora Research Inc.
InventorsFabio Eduardo Silva e Souza, Ming Pan, Kathleen Da Silva Turcot
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Abstract
Paricalcitol, a synthetic vitamin D analog, is purified to a purity greater than 99.7% by crystallization from solution in isopropyl acetate solvent, followed by filtration and vacuum drying. Isopropyl acetate appears to be unique among commonly available and pharmaceutically acceptable solvents in its ability to precipitate paricalcitol in this high purity, essentially free of isomers thereof. In addition, paricalcitol of purity of at least 99.9% has been shown to have exceptional storage stability.
Claims4
Stabilized paricalcitol having a purity of at least 99.9% and exhibiting no reduction in purity in accelerated stability tests characterized by storage under an air headspace for 1 month at 40±2° C. and 75%±2% relative humidity.
Dependencies are inferred from the claim text.