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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.

Rivaroxaban Ethylamino Analog (2HCl Salt)

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Catalogue No.:	VE0027969
CAS No.:	N/A
Mol. Formula:	C18H22Cl3N3O4S
Mol. Weight:	482.81 g/mol

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Additional information on

Parent drug

Rivaroxaban

IUPAC Name

1-amino-3-((4-(3-oxomorpholino)phenyl)amino)propan-2-yl 5-chlorothiophene-2-carboxylate dihydrochloride

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

O=C(C1=CC=C(Cl)S1)OC(CNC2=CC=C(N3C(COCC3)=O)C=C2)CN.[H]Cl.[H]Cl

InChI

InChI=1S/C18H20ClN3O4S.2ClH/c19-16-6-5-15(27-16)18(24)26-14(9-20)10-21-12-1-3-13(4-2-12)22-7-8-25-11-17(22)23;;/h1-6,14,21H,7-11,20H2;2*1H

Description

Rivaroxaban ethylamino analog (2HCl salt) is a characterized process-related impurity observed during rivaroxaban manufacture and stability studies. This impurity exhibits distinct mass spectral and chromatographic behavior, facilitating identification by LC-MS/MS and HPLC-UV methods. Analytical profiling indicates potential formation via ethylamine incorporation or salt transformation under acidic conditions, making it a relevant target for impurity profiling, method validation, and stability-indicating assays. Control strategies include specification setting, limit establishment and use as a reference material for forced degradation studies and batch release testing. Detailed impurity data support regulatory submissions and quality risk assessments for rivaroxaban drug substance manufacturing.