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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

Romidepsin Impurity B

● Under Development

Catalogue No.:	VE0011471
CAS No.:	N/A
Mol. Formula:	C24H36N4O6S2
Mol. Weight:	540.70 g/mol

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Additional information on Romidepsin Impurity B

Parent drug

Romidepsin

IUPAC Name

(E)-4,22-diisopropyl-7-methylene-2-oxa-12,13-dithia-5,8,21,24-tetraazabicyclo[8.7.7]tetracos-16-ene-3,6,9,20,23-pentaone

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

CC(C1C(NC2C(NC(C(NC(C(OC(CCC(N1)=O)/C=C/CCSSC2)=O)C(C)C)=O)=C)=O)=O)C

InChI

InChI=1S/C24H36N4O6S2/c1-13(2)19-23(32)26-17-12-36-35-11-7-6-8-16(9-10-18(29)27-19)34-24(33)20(14(3)4)28-21(30)15(5)25-22(17)31/h6,8,13-14,16-17,19-20H,5,7,9-12H2,1-4H3,(H,25,31)(H,26,32)(H,27,29)(H,28,30)/b8-6+

Description

The Romidepsin Impurity B standard is a well-characterized compound that aligns with key regulatory guidelines, including USP, EMA, JP, and BP. It plays a crucial role in analytical method development, method validation (AMV), and quality control (QC) processes, particularly in the manufacturing of Romidepsin .This impurity standard is valuable for both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA), ensuring reliable and precise analytical outcomes.