BRIEFING
Tavaborole Topical Solution. 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 Kromasil C18 brand of column with L1 packing. The typical retention time for tavaborole is about 5 min.
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The gas chromatographic procedure in the Content of Alcohol test was validated using the DB-FFAP brand of column with G35 phase. The typical retention time for alcohol is about 5 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the Alltima C18 brand of column with L1 packing. The typical retention time for tavaborole is about 15 min.
(SM1: J. Li)
Case ID—SUB-1306, SUB-1341