357424-21-6Varenicline Hydroxy Impurity

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Catalogue No.:	VE007008
CAS No.:	357424-21-6
Mol. Formula:	C13H13N3O
Mol. Weight:	227.26 g/mol

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Additional information on CAS 357424-21-6

Parent drug

Varenicline

IUPAC Name

7,8,9,10-Tetrahydro-2-hydroxy-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine

Synonyms

N/A

Description

Varenicline Hydroxy Impurity, CAS 357424-21-6, is the oxygenated analog of varenicline with molecular formula C13H13N3O and molecular weight 227.26 g/mol. The structure is consistent with a monohydroxylated process or degradative impurity arising from oxidative modification of the varenicline scaffold rather than a nitrosamine class entity. Its polar functionality can alter chromatographic retention and complicate trace-level separation from the parent compound and related analogs. Quantification typically requires LC-MS/MS or high-resolution LC-MS, with orthogonal confirmation by NMR or HPLC-UV after enriched isolation. Regulatory assessment follows impurity profiling principles, with attention to formation pathways and structural qualification.