Romidepsin
C24H36N4O6S2
540.69
Cyclo[(2Z)-2-amino-2-butenoyl-l-valyl-(3S,4E)-3-hydroxy-7-mercapto-4-heptenoyl-d-valyl-d-cysteinyl], cyclic (3→5)-disulfide;
(1S,4S,7Z,10S,16E,21R)-7-Ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone [128517-07-7]
Cyclo[(2Z)-2-amino-2-butenoyl-l-valyl-(3S,4E)-3-hydroxy-7-mercapto-4-heptenoyl-d-valyl-d-cysteinyl], cyclic (3→5)-disulfide;
(1S,4S,7Z,10S,16E,21R)-7-Ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone [128517-07-7]
BRIEFING
Romidepsin. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed. The liquid chromatographic procedure in the Assay and the test for Organic Impurities was validated using the Synergi Fusion-RP brand of column with L1 packing. The typical retention time for romidepsin is about 12 min.
Description and solubility information: White to off-white crystalline powder. Soluble in dichloromethane; very slightly soluble in methanol; insoluble in water.
(SM3: A. Leeks, Jr.)
Case ID—SUB-2816