BRIEFING
Letermovir 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 used in the Assay and Dissolution test was validated using the Kromasil 100-5-C18 brand of column with L1 packing. The typical retention time for letermovir is about 4 min.
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The liquid chromatographic procedure used in the Organic Impurities test was validated using the Kromasil 100-5-C18 brand of column with L1 packing. The typical retention time for letermovir is about 40 min.
This monograph is contingent on FDA approval of a product that meets the proposed monograph specifications. Please see the Pending Monograph Guideline for additional information.
(SM1: J. Kilari)
Case ID—SUB-1243, SUB-2901