BRIEFING
Dalfampridine Extended-Release 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 is based on analyses performed with the Symmetry C18 brand of column with L1 packing. The typical retention time for dalfampridine is about 7 min.
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The liquid chromatographic procedure used in the test for Organic Impurities is based on analyses performed with the Inertsil ODS-4 brand of column with L1 packing. The typical retention time for dalfampridine is about 37 min.
(SM4: G. Daddala)
Case ID—SUB-1715