بوسنتان مونوهیدرات

BOSENTAN MONOHYDRATE

International non-proprietary name (INN):
BOSENTAN (USAN has adopted this name for
the monohydrate form)


Chemical Abstract Index name:
۴-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-
methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-
۴-yl]benzene-1-sulfonamide, monohydrate


CAS Registry No :
157212-55-0

Indication:
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.

Structure

Physical form and appearance : White to yellowish powder

Physical state: Solid

Form: Powder

Molecular weight: 569.63 g/mol

Molecular formula: C27H29N5O6S . H2O

Identification: HPLC

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.

Technical specification:
(HPLC): 99.5%

Related substance (HPLC)

Individual impurity ≤ .۲۰%

Total impurities ≤ .۵۰%

Method: In-House method as per ICH


Guidelines :