Highly pure phentolamine mesylate
AssigneeOcuphire Pharma, Inc.
InventorDaniela Carmen Oniciu
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Abstract
This invention provides methods for synthesizing phentolamine mesylate from phentolamine and methanesulfonic acid in the presence of acetone and water. The methods of the present invention provide highly pure phentolamine mesylate. The invention also provides highly pure phentolamine mesylate.
Claims25
Phentolamine mesylate exhibiting an X-ray powder diffraction (XRPD) pattern comprising a peak at 6.87±0.2 degrees 2-theta, a peak at 11.65±0.2 degrees 2-theta, a peak at 13.15±0.2 degrees 2-theta, a peak at 18.86±0.2 degrees 2-theta, a peak at 20.32±0.2 degrees 2-theta, a peak at 20.85±0.2 degrees 2-theta, a peak at 21.07±0.2 degrees 2-theta, and a peak at 21.36±0.2 degrees 2-theta;
- comprising 0% water by weight to 8% water by weight of the phentolamine mesylate as determined by Karl Fischer titration;
- and comprising less than 1% of another impurity by weight of the phentolamine mesylate.
Dependencies are inferred from the claim text.