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New Jersey, USA
Czech Republic, EU
Mumbai, India

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Dokumentation

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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 N1-Methyl Ester Impurity

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Katalog-Nr.::	VE0027856
CAS-Nr.::	N/A
Summenformel::	C16H19N5O2
Molare Masse::	313.35 g/mol

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Zusätzliche Informationen zu

Parent drug

Upadacitinib

IUPAC-Name

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

Pharmacopeial Synonyms

N/A

Synonyme

N/A

SMILES

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

InChI

InChI=1S/C16H19N5O2/c1-3-10-8-20(16(22)23-2)9-11(10)13-6-18-14-7-19-15-12(21(13)14)4-5-17-15/h4-7,10-11,17H,3,8-9H2,1-2H3/t10-,11+/m1/s1

Beschreibung

Upadacitinib N1-Methyl Ester Impurity is a process-related degradation product encountered during the synthesis and purification of upadacitinib, requiring targeted analytical control to ensure drug substance quality. This impurity is typically monitored at trace levels using orthogonal techniques such as HPLC with UV detection, LC-MS for mass confirmation, and NMR for structural elucidation, enabling reliable identification and quantification. Risk-based mitigation includes optimization of methylation and esterification steps, selective chromatographic purification, and established acceptance criteria consistent with regulatory guidance for impurity qualification. Comprehensive documentation of occurrence, analytical methods, and control strategies supports robust quality assurance and regulatory submissions.