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Tolterodine Tartrate Tablets

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.

  1. 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.

  2. 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.

  3. 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

USP REFERENCE STANDARDS FOR PURCHASE

USP Tolterodine Tartrate RS
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