Piperazine, 1-{2-[(2,4-dimethylphenyl)thio]phenyl}-, hydrobromide (1:1);
1-{2-[(2,4-Dimethylphenyl)thio]phenyl}piperazine monohydrobromide [960203-27-4]
BRIEFING
Vortioxetine Hydrobromide. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
-
The liquid chromatographic procedure in the Assay and test for Organic Impurities, Procedure 1 is based on validations performed with the Luna Phenyl-Hexyl brand of column with L11 packing. The retention time observed for vortioxetine in the Assay and test for Organic Impurities, Procedure 1 is between 22 and 29 min.
-
The gas chromatographic procedure in the test for Organic Impurities, Procedure 2 is based on validations performed with the DB-200 brand of column with G6 stationary phase. The typical retention time for vortioxetine is about 19 min.
Description and Solubility information: White to very slightly beige powder. Soluble in ethanol and in methanol. Slightly soluble in water.
(SM4: D. Singh)
Case ID—SUB-674
USP REFERENCE STANDARDS FOR PURCHASE
USP Vortioxetine Hydrobromide RSUSP Vortioxetine Related Compound G RS
USP Vortioxetine Related Compound H RS
USP Vortioxetine Related Compound I RS