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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.

Duloxetine Nitroso Impurity (Mixture of Diastereomer)

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Catalogue No.:	VE007668
CAS No.:	N/A
Mol. Formula:	C18H18N2O2S
Mol. Weight:	326.41 g/mol

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Additional information on Duloxetine Nitroso Impurity (Mixture of Diastereomer)

Parent drug

Duloxetine

IUPAC Name

(S)-N-methyl-N-(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)nitrous amide

Smiles

CN(N=O)CC[C@](C1=CC=CS1)([H])OC2=CC=CC3=CC=CC=C32

InChI

InChI=1S/C18H18N2O2S/c1-20(19-21)12-11-17(18-10-5-13-23-18)22-16-9-4-7-14-6-2-3-8-15(14)16/h2-10,13,17H,11-12H2,1H3/t17-/m0/s1

Synonyms

N/A

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Description

Duloxetine Nitroso Impurity (Mixture of Diastereomer) is a nitrosamine-related process impurity associated with the secondary amine functionality of duloxetine, typically arising from nitrosating conditions during synthesis, workup, or storage. With molecular formula C18H18N2O2S and molecular weight 326.41 g/mol, it represents a structurally concerning species because N-nitroso compounds are evaluated under ICH M7 due to potential mutagenic and genotoxic liability. Its diastereomeric mixture may affect chromatographic behavior and peak shape. Trace-level assessment generally requires selective LC-MS/MS, high-resolution mass spectrometry, or GC-MS methods with stringent control of isomeric separation and low detection limits.