2H-Benzo[a]quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-;
(3RS,11bRS)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one [58-46-8]
BRIEFING
Tetrabenazine. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal of this monograph which appeared in PF 44(3) [May–Jun. 2018] was canceled due to comments received. The procedure in the Assay is based on the same chromatographic system as the procedure in the test for Organic Impurities. The LC method is validated using the Zorbax Eclipse XDB C18 brand of column with L1 packing. The typical retention time for tetrabenazine is about 31 min.
Description and solubility information: White to off-white to slightly yellow to pale-yellow powder or crystalline powder. Soluble in chloroform; sparingly soluble in methanol.
(SM4: T. Bililign)
Correspondence Number—C297913
USP REFERENCE STANDARDS FOR PURCHASE
USP Tetrabenazine RSUSP Tetrabenazine Related Compound B RS
USP Tetrabenazine Related Compound C RS