BOSENTAN (USAN has adopted this name for
the monohydrate form)
Chemical Abstract Index name:
CAS Registry No : 157212-55-0
Bosentan is an endothelin receptor antagonist. Used in the management of pulmonary hypertension and systemic sclerosis. It has also been investigated in heart failure and in hypertension.
Physical state: Solid
Molecular weight: 569.63 g/mol
Molecular formula: C27H29N5O6S . H2O
Assay (HPLC): 99-101% w/w
Solubility: Insoluble in water, Freely soluble in acetone and in dichloromethane; soluble in ethanol, Ethyl acetate, acetonitrile and dimethylformamide; slightly soluble in methanol and iso-propanol; very slightly soluble in hexane.
Storage: Keep container tightly closed and store at room temperature. This material should be handled and stored per label instructions to ensure product integrity.
Related substance (HPLC)
Individual impurity ≤ .۲۰%
Total impurities ≤ .۵۰%
Method: In-House method as per ICH