Upadacitinib Hemihydrate Powder｜High-Purity JAK1 Selective Inhibitor for Autoimmune Drug
R&DHighlighted:
Highly selective JAK1-targeted API for autoimmune inflammatory drug development; strict purity and impurity control, stable batch-to-batch consistency, and comprehensive compliant testing documentation, supporting global formulation R&D, pharmacology studies, and academic research procurement.
Product Overview
Upadacitinib Hemihydrate Powder for research-grade preclinical and pilot-scale R&D is a widely used JAK1 selective inhibitor API with a stable chemical structure, controllable crystal form, and physicochemical properties suitable for oral tablet and sustained-release formulation development. This API is intended solely for human pharmaceutical R&D applications.
It primarily serves global pharmaceutical companies, CROs, academic laboratories, and cross-border pharmaceutical traders. With mature synthesis, purification, and crystallization processes, the powder meets international API quality standards and can be directly applied in early-stage drug discovery, pilot-scale trials, formulation development, and pharmacology/toxicology research.
It provides a stable, traceable, and research-grade raw material for studying autoimmune diseases such as atopic dermatitis, rheumatoid arthritis, and ulcerative colitis, supporting preclinical and pilot-scale drug R&D.
COA
| Item | Specification | Result | |
| Appearance | White to light brown or light gray powder. | Light yellow powder. | |
| Solubility | Freely soluble in ethanol and in tetrahydrofuran, Insoluble in Heptane and in water. | Freely soluble in ethanol and in tetrahydrofuran, Insoluble in Heptane and in water. | |
| HPLC Identification |
The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Enantiomer. | Complies | |
| IR Identification |
The infrared absorption spectrum of the sample shall be consistent with that of the reference substance. | Complies | |
| Organic impurities |
UP‑Impurity 2 : not more than 0.15% UP‑2 : not more than 0.15% Other single impurities : not more than 0.10% Total impurities: not more than 0.50% |
Not detected Not detected 0.031% 0.090% |
|
| Enantiomer | Impurity A : not more than 0.10% | Not detected | |
| Residual solvents |
Ethanol: not more than 5000ppm Ethyl acetate: not more than 5000ppm Tetrahydrofuran: not more than 720ppm Heptane: not more than 5000ppm |
353.5ppm 477.1ppm Not detected 91.33ppm |
|
| Water | Should be between 2.0% and 3.0% | 2.40% | |
| Residue on ignition | Not more than 0.1% | 0.02% | |
| Heavy metal | Not more than 20ppm | Complies | |
| Assay | NLT 98.0% and NMT 102.0% of C₁₇H₁₉F₃N₆O, calculated on the anhydrous basis. | 99.10% | |
| Conclusion | The product complies with the requirements | ||
Mechanism of Action
Upadacitinib Hemihydrate Powder, a selective JAK1 inhibitor for research-grade R&D, blocks the JAK1 signaling pathway, suppressing pro-inflammatory cytokine production. This targeted mechanism modulates immune responses in autoimmune diseases, ensuring consistent pharmacological effects for preclinical and pilot-scale studies.
Product Applications
This Upadacitinib Hemihydrate Powder is intended exclusively for pharmaceutical and academic R&D. Main applications:
● Preclinical and pilot-scale development of oral tablets and sustained-release formulations
● Pharmacology, toxicology, and pharmacokinetics studies of JAK1-targeted autoimmune drug candidates
● Supporting global pharmaceutical companies and R&D institutions in autoimmune disease drug development
● Serving as a pharmaceutical intermediate for cross-border trade, providing compliant raw materials for overseas formulation projects
● Academic research on JAK signaling pathways and immune regulation mechanisms
Benifits of Upadacitinib Hemihydrate Powder
● Potent Anti-Inflammatory Effect: As a selective JAK1 inhibitor API, Upadacitinib Hemihydrate Powder specifically blocks the JAK1 signaling pathway, suppressing pro-inflammatory cytokine production and enhancing therapeutic outcomes in autoimmune disease preclinical studies
● Targeted Modulatory Action: High selectivity for JAK1 minimizes off-target effects on JAK2 and JAK3, improving safety in experiments
● Stable Bioavailability: Hemihydrate form optimizes solubility, improves absorption, reduces plasma concentration fluctuations, and ensures consistent pharmacological effects
● Chemical and Physical Stability: Resistant to hydrolysis and oxidation, maintaining activity for long-term preclinical studies and scalable production
Core Advantages
￭ Clear Target Mechanism: Specific JAK1 selective inhibitor mechanism with extensive pharmacology data
￭ Stable Batch Quality: Standardized synthesis and crystallization minimize variations
￭ Comprehensive Compliance Documentation: COA, MSDS, batch traceability for regulatory verification
￭ Flexible Supply: Multiple packaging options for samples, small-scale, and mid-scale orders
￭ Mature Cross-Border Delivery: Full export compliance for smooth international shipping
￭ Continuous Supply: Scalable production ensures sufficient inventory and consistent delivery
Quality Assurance
￭ Full-process Standardization: HPLC, moisture, impurity, and appearance tests on all batches
￭ Strict Impurity Control: Organic impurities, residual solvents, and heavy metals comply with ICH limits
￭ Complete Batch Traceability: Unique batch IDs with full production, testing, and shipping traceability
￭ Professional Storage: Low temperature, light-protected, moisture-proof handling
￭ After-Sales Support: Application consulting and data interpretation
FAQ
Q1: Can this API be used directly for commercial formulation production?
A1: It is a research-grade API, suitable for preclinical studies and pilot-scale trials. Commercial production requires regulatory-compliant API grade and documentation.
Q2: Can samples be provided for preliminary testing?
A2: Yes, small quantities with complete COA documentation are available.
Q3: Can custom purity or crystal form specifications be made?
A3: Yes, specifications can be tailored to project needs.
factory
Certificates
Shipping & Packing
Cooperation & Orders
Upadacitinib Hemihydrate Powder for research-grade preclinical and pilot-scale R&D supports stable physicochemical properties, rigorous quality control, complete documentation, and flexible supply, enabling efficient global autoimmune drug formulation development. Contact us for pricing, sample requests, COA files, or custom supply solutions.
Contact:Whatsapp & Mobile: +8619991242181
Email:sales@hdmbio.com
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