BRIEFING
Fesoterodine Fumarate Extended-Release Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedures in the Assay and Dissolution test were validated using the Hypersil-ODS brand of column with L1 packing. The typical retention time for fesoterodine is about 2.4 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the Zorbax Rx-C8 brand of column with L7 packing. The typical retention time for fesoterodine is about 15 min.
(SM3: M. Chang)
Case ID—SUB-1058