BRIEFING
Rufinamide Oral Suspension. 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 rufinamide is about 16 min.
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The liquid chromatographic analytical procedure in the Dissolution test was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for rufinamide is about 2 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the YMC Triart C18 brand of column with L1 packing. The typical retention time for rufinamide is about 32 min.
(SM4: R. Nguyen)
Case ID—SUB-645