Propanoic acid, 2-methyl-, 2-[(1R)-3-[bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl ester, (2E)-2-butenedioate (1:1) (salt);
(R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-(hydroxymethyl)phenyl isobutyrate hydrogen fumarate [286930-03-8]
BRIEFING
Fesoterodine Fumarate. 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 used in the Assay is based on validation using the Kromasil C18 brand of column with L1 packing. The typical retention time for fesoterodine is about 4 min.
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The liquid chromatographic procedure used in the test for Organic Impurities is based on validation using the Kromasil C8 brand of column with L7 packing. The typical retention time for fesoterodine is about 17 min.
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The liquid chromatographic procedure used in the test for Limit of Fesoterodine S-Enantiomer is based on validation using the Chiralcel OD-H brand of column with L40 packing. The typical retention times for the fesoterodine and fesoterodine S-enantiomer are about 8 and 13 min, respectively.
Description and solubility information: White to off-white powder. It is soluble in water; freely soluble in methanol; practically insoluble in heptane.
(SM3: I. Salahudeen)
Correspondence Number—C207139
USP REFERENCE STANDARDS FOR PURCHASE
USP Fesoterodine Chloromandelate RSUSP Fesoterodine Fumarate RS