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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.

N-Nitroso Ozanimod Impurity

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Catalogue No.:	VE009803
CAS No.:	N/A
Mol. Formula:	C23H23N5O4
Mol. Weight:	433.36 g/mol

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Additional information on N-Nitroso Ozanimod Impurity

Parent drug

Ozanimod

IUPAC Name

(S)-N-(4-(5-(3-cyano-4-isopropoxyphenyl)-1,2,4-oxadiazol-3-yl)-2,3-dihydro-1H-inden-1-yl)-N-(2-hydroxyethyl)nitrous amide

FDA Potency Category 3 NDSRI

400 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-ozanimod (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.

Pharmacopoeial Synonyms

N/A

Other Synonyms

Ozanimod Nitroso Impurity

Smiles

O=NN([C@H]1CCC2=C1C=CC=C2C3=NOC(C4=CC=C(OC(C)C)C(C#N)=C4)=N3)CCO

InChI

InChI=1S/C23H23N5O4/c1-14(2)31-21-9-6-15(12-16(21)13-24)23-25-22(26-32-23)19-5-3-4-18-17(19)7-8-20(18)28(27-30)10-11-29/h3-6,9,12,14,20,29H,7-8,10-11H2,1-2H3/t20-/m0/s1

Description

N-Nitroso Ozanimod Impurity, also referred to as Ozanimod Nitroso, is a nitrosamine derivative of ozanimod with molecular formula C23H23N5O4 and molecular weight 433.36 g/mol. The N-nitroso functionality places this species within the class of potentially genotoxic impurities, with formation plausibly arising during nitrosating conditions applied to amine-containing intermediates or the active substance. Such compounds are evaluated under ICH M7 and related nitrosamine risk frameworks because trace-level exposure may be clinically significant. Characterization and quantification typically require LC-MS/MS, high-resolution LC-MS, and, where volatility permits, GC-MS with selective ion monitoring.