Benzenesulfonamide, 4-(1,1-dimethylethyl)-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2’-bipyrimidin]-4-yl]-, monohydrate;
p-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(o-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]benzenesulfonamide monohydrate [157212-55-0]
BRIEFING
Bosentan. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay is based on validation performed with the Zorbax SB-Phenyl brand of column with L11 packing. The typical retention time for bosentan is about 11 min.
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The liquid chromatographic procedure in the test for Organic Impurities is based on validation performed with the Zorbax Eclipse XDB C18 brand of column with L1 packing. The typical retention time for bosentan is about 18 min.
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The gas chromatographic procedure in the test for Limit of Ethylene Glycol is based on validation performed with the DB-WAX brand of column with stationary phase G16. The typical retention time for ethylene glycol is about 12 min.
Description and Solubility information: White to yellowish powder. Soluble in N,N-dimethylformamide and in acetonitrile. Slightly soluble in water and in aqueous solutions at low pH. Solubility increases at higher pH values.
(SM5: M. Koleck)
Correspondence Number—C217432