Crystalline forms of bosentan salts and processes for their preparation
The present invention relates to crystalline forms of bosentan salts and processes for their preparation.(FORMULA)
1. Crystalline Form A of bosentan potassium having an XRPD pattern comprising interplanar spacing (d) values substantially at 3.31, 3.70, 3.73, 3.82, 4.00, 4.26, 4.44, 4.55, 4.74, 4.84, 4.96, 5.29, 5.49, 8.74, 13.78, 14.76, 15.97, 19.89, and 21.54 (Å).
2. Crystalline Form A of bosentan potassium having an XRPD pattern substantially as depicted in FIG. 1 or the DSC pattern substantially as depicted in FIG. 3 .
3. A process for preparing crystalline Form A of bosentan potassium, wherein the process comprises:
a) treating bosentan with a potassium ion source in the presence of an organic solvent or a mixture of organic solvents; and
b) isolating crystalline Form A of bosentan potassium from the mixture thereof.
4. A process for preparing crystalline Form A of bosentan potassium, wherein the process comprises:
a) treating bosentan potassium with a first organic solvent;
b) treating the mixture obtained in step a) with a second organic solvent; and
c) isolating crystalline Form A of bosentan potassium from the mixture thereof.
5. Crystalline Form A of bosentan potassium prepared according to claim 3 or 4 , having a purity of about 98% or above.
6. Crystalline Form A of bosentan potassium prepared according to claim 3 or 4 , having a purity of about 99% or above.