Category
Upadacitinib
CAS Number
18262-01-6
Molecular Formula
C₆H₈O₇
Molecular Weight
192.12 g/mol
Synonym

2-acetyloxy-3-hydroxybutanedioic acid; Butanedioic acid, 2-(acetyloxy)-3-hydroxy; Tartaric acid, monoacetate; 2-Acetoxy-3-hydroxysuccinic Acid; 2-acetoxy-3-hydroxysuccinic acid;Butanedioic acid,2-(acetyloxy)-3-hydroxy

Keywords
Pharmaceutical Standards
Impurities
Intermediates
Metabolites.
Fine Chemicals
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Upadacitinib Monoacetyl Impurity is a process-related impurity associated with Upadacitinib that can form during its synthesis or purification steps when partial acetylation occurs. It is considered a structurally related by-product and is monitored during pharmaceutical quality control to ensure drug safety, purity, and regulatory compliance. Sensitive analytical techniques like HPLC and LC-MS are typically used to detect and quantify this impurity at trace levels in active pharmaceutical ingredient (API) batches.