Description

Upadacitinib Hemihydrate is a selective and reversible Janus kinase (JAK) inhibitor, specifically targeting JAK1. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted immunomodulatory therapies. It is primarily utilized by pharmaceutical companies and research institutions engaged in the production of advanced treatments for autoimmune and inflammatory diseases, such as rheumatoid arthritis, atopic dermatitis, and psoriatic arthritis.

Application

• Primary Active Pharmaceutical Ingredient (API) in the formulation of oral JAK inhibitor medications.
• Key intermediate in advanced pharmaceutical research and development for novel immunomodulators.
• Reference standard for quality control and analytical method development in pharmaceutical laboratories.
• Biochemical research tool for studying JAK-STAT signaling pathways and related inflammatory processes.
• Manufacturing of finished dosage forms for the treatment of rheumatoid arthritis (RA).
• Production of therapeutics for atopic dermatitis (AD) and psoriatic arthritis (PsA).
• Investigational use in clinical trials for other autoimmune conditions.

Basic Information

Product Name	Upadacitinib Hemihydrate
CAS No.	2050057-56-0
Molecular Formula	C₁₇H₂₀N₆O₂ • ½H₂O
Molecular Weight	348.39 g/mol (hemihydrate)
Synonyms	Upadacitinib Hemihydrate; ABT-494 Hemihydrate; RINVOQ (brand name API form); (3S,4R)-3-Ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hemihydrate; JAK1 Inhibitor ABT-494; UNII-4S6XK2E1GC (hemihydrate); Upadacitinib Monohydrate (common alternate naming); ABT 494 Hemihydrate
EINECS	Contact for details

Quality Control

Our Upadacitinib Hemihydrate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	1.5% - 3.5%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm
Residue on Ignition	< 0.1%
Specific Rotation	Contact for details

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.