BRIEFING
Tacrolimus Extended-Release Capsules. 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 TSKgel ODS-80Tm brand of column with L1 packing. The typical retention time for tacrolimus is about 10 min.
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The liquid chromatographic procedure in the Dissolution Tier 1 test was validated using the Nucleosil-C8 brand of column with L7 packing. The typical retention time for tacrolimus is about 14 min.
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The liquid chromatographic procedure in the Dissolution Tier 2 test was validated using the Ascentis Express C18 brand of column with L1 packing. The typical retention time for tacrolimus is about 14 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the SUPELCOSIL LC-Diol brand of column with L20 packing. The typical retention time for tacrolimus is about 15 min.
(SM1: S. Shane)
Case ID—SUB-502