BRIEFING
Tetrabenazine 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 procedure in the Assay is a liquid chromatographic method validated using the Ascentis Express C18 brand of column with L1 packing. The procedure in the Dissolution test was also validated using the same chromatographic system. The typical retention time for tetrabenazine is about 4 min.
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The procedure in the test for Organic Impurities is a liquid chromatographic method validated using the Purospher Star RP 18e brand of column with L1 packing. The typical retention time for tetrabenazine is about 25 min.
(SM4: T. Bililign)
Correspondence Number—C209179; C297756