BRIEFING
Tolterodine Tartrate 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 procedure in the Assay was validated using the Symmetry Shield RP8 brand of column with L7 packing. The typical retention time for tolterodine is about 4 min.
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The liquid chromatographic procedure in the Dissolution test was validated using the XTerra Shield RP18 brand of column with L1 packing. The typical retention time for tolterodine is about 6 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for tolterodine is about 26 min.
(SM3: J. Kilari)
Case ID—SUB-1100