Methods for the purification of levofloxacin
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsValerie Niddam-Hildesheim, Neomi Gershon, Eduard Schwartz
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Abstract
Levofloxacin has been purified by dissolving levofloxacin in a polar solvent at an elevated temperature and crystallizing purified levofloxacin. Preferably, an antioxidant is added to increase the purity.
Claims36
A process for preparing levofloxacin having a purity of about 99% or greater, comprising:
- dissolving levofloxacin in a polar solvent at an elevated temperature;
- and
- crystallizing purified levofloxacin.
A process for preparing levofloxacin hemihydrate having a purity of about 99% or greater, comprising:
- dissolving levofloxacin in a polar solvent at an elevated temperature;
- and
- crystallizing levofloxacin hemihydrate.
A process for preparing levofloxacin having a purity of about 99% or greater, comprising:
- dissolving levofloxacin in a polar solvent;
- adding an antioxidant;
- and
- crystallizing purified levofloxacin,
- wherein the adding step occurs before or after the dissolving step and before the crystallizing step.
A process for preparing levofloxacin having a purity of about 99% or greater comprising converting (S)-(−)-9,10-Difluoro-3-Methyl-7-oxo-2,3-Dihydro-7H-Pyrido[1,2,3-de][1,4]Benzoxazine-6-Carboxylic Acid to levofloxacin at an elevated temperature in the presence of an antioxidant.
Dependencies are inferred from the claim text.