BRIEFING
Emtricitabine Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedures in the Assay and the test for Dissolution were validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for emtricitabine is about 5 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Discovery HS F5 brand of column with L43 packing. The typical retention time for emtricitabine is about 34 min.
(SM1: S. Shane)
Case ID—SUB-1657, SUB-3361