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Enthält: HPLC, MASS/LC-MS, 1H-NMR, FT-IR, Gehalt, Structure Elucidation Report (SER) sowie zusätzliche analytische Daten je nach Produkt.

Upadacitinib N-Methyl Impurity

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Katalog-Nr.::	VE0027849
CAS-Nr.::	N/A
Summenformel::	C18H21F3N6O
Molare Masse::	394.39 g/mol

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Zusätzliche Informationen zu

Parent drug

Upadacitinib

IUPAC-Name

(3S,4R)-3-ethyl-4-(3-methyl-3H-imidazo[1,2-a]pyrrolo [2,3- e]pyrazin-8-yl)-N-(2,2,2- trifluoroethyl)pyrrolidine-1- carboxamide

Pharmacopeial Synonyms

N/A

Synonyme

N/A

SMILES

O=C(N1C[C@@H](CC)[C@@H](C2=CN=C3C=NC(N(C)C=C4)=C4N32)C1)NCC(F)(F)F

InChI

InChI=1S/C18H21F3N6O/c1-3-11-8-26(17(28)24-10-18(19,20)21)9-12(11)14-6-22-15-7-23-16-13(27(14)15)4-5-25(16)2/h4-7,11-12H,3,8-10H2,1-2H3,(H,24,28)/t11-,12+/m1/s1

Beschreibung

Upadacitinib N-Methyl Impurity is a process-related byproduct arising from secondary N-methylation during Upadacitinib synthesis, requiring targeted control within the impurity profile. Characterization by high performance liquid chromatography and LC-MS provides retention time, accurate mass and fragment ion data for confident identification, while validated quantitative assays support routine monitoring. Risk assessment addresses potential impact on potency, stability and safety, guiding qualification thresholds consistent with ICH Q3A and Q3B expectations. Mitigation strategies include optimized reaction conditions and purification steps, and certified reference materials enable method validation and batch release decisions for regulatory compliance.