Benzenepropanoic acid, α-[(4,6-dimethyl-2-pyrimidinyl)oxy]-β-methoxy-β-phenyl-, (S)-;
(S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid [[177036-94-1]]
BRIEFING
Ambrisentan. Because there is no USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
-
The liquid chromatographic procedure used in the Assay is based on analyses performed using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for ambrisentan is about 5 min.
-
The liquid chromatographic procedure used in the test for Organic Impurities is based on analyses performed using the XSelect CSH Fluoro-Phenyl brand of column with L43 packing. The typical retention time for ambrisentan is about 22 min.
-
The liquid chromatographic procedure used in the test for Limit of Ambrisentan Related Compound E is based on analyses performed using the Luna C18 brand of column with L1 packing. The typical retention time for ambrisentan related compound E is about 5 min.
-
The liquid chromatographic procedure in the test for Enantiomeric Purity was validated using the Chiralpak AD-H brand of column with L51 packing. The typical retention time for ambrisentan is about 6 min.
(SM5: S. Ramakrishna)
Correspondence Number—C207173; C216992; C295654