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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.

Upadacitinib Ditosyl Impurity

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Catalogue No.:	VE0027857
CAS No.:	N/A
Mol. Formula:	C28H29N5O4S2
Mol. Weight:	563.69 g/mol

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Additional information on

Parent drug

Upadacitinib

IUPAC Name

8-((3R,4S)-4-ethyl-1-tosylpyrrolidin-3-yl)-3-tosyl-3H-imidazo[1,2-a]pyrrolo[2,3- e]pyrazine

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

O=S(N1C=CC2=C1N=CC3=NC=C([C@H]4CN(S(=O)(C5=CC=C(C)C=C5)=O)C[C@H]4CC)N32)(C6=CC=C(C)C=C6)=O

InChI

InChI=1S/C28H29N5O4S2/c1-4-21-17-31(38(34,35)22-9-5-19(2)6-10-22)18-24(21)26-15-29-27-16-30-28-25(33(26)27)13-14-32(28)39(36,37)23-11-7-20(3)8-12-23/h5-16,21,24H,4,17-18H2,1-3H3/t21-,24+/m1/s1

Description

Upadacitinib Ditosyl Impurity is a process related contaminant arising from tosylate counterion incorporation or side reactions during salt formation and purification. This impurity can alter physicochemical properties including solubility, crystal habit, and residual counterion content, and it is routinely monitored by orthogonal analytical techniques such as reversed phase HPLC with UV detection and LC-MS for mass confirmation, supplemented by 1H NMR for structural assessment. Control strategies focus on optimized counterion exchange, targeted recrystallization, and ion exchange chromatography to reduce levels to acceptable limits. Detailed impurity profiling and validated analytical methods ensure product quality and regulatory compliance.