Description
Upadacitinib is a highly selective and reversible Janus kinase (JAK) inhibitor that demonstrates significant therapeutic potential in the treatment of autoimmune disorders. As a premium pharmaceutical chemical, our Upadacitinib Active Pharmaceutical Ingredient (API) is manufactured under strict quality control protocols to ensure consistency, purity, and compliance with international pharmacopeial standards. This small molecule therapeutic agent represents the forefront of targeted immunomodulation, offering precise inhibition of JAK1 with minimal off-target effects.
Specifications of Upadacitinib API
| Parameter | Specification |
|---|---|
| Product Name | Upadacitinib |
| CAS Number | 1310726-60-3 |
| Chemical Name | (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 |
| Molecular Formula | C₁₇H₁₉F₃N₆O |
| Molecular Weight | 380.37 g/mol |
| Appearance | White to off-white crystalline powder |
| Purity (HPLC) | ≥99.0% |
| Heavy Metals | ≤10 ppm |
| Residual Solvents | Complies with ICH guidelines |
| Water Content (KF) | ≤0.5% |
| Assay | 98.5-101.0% |
| Storage Conditions | Store at 2-8°C in a dry, dark place |
| Shelf Life | 24 months when stored properly |
| Stability | Stable under recommended storage conditions |
Pharmaceutical Chemicals Features
1. High Selectivity Profile
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Demonstrates preferential inhibition of JAK1 over JAK2, JAK3, and TYK2
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Minimizes potential hematological side effects associated with broader JAK inhibition
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Offers targeted therapeutic action with reduced off-target interactions
2. Superior Quality Standards
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Manufactured in compliance with cGMP (current Good Manufacturing Practices)
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Multiple purification stages ensure exceptional chemical purity
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Rigorous analytical testing including HPLC, NMR, and mass spectrometry
3. Enhanced Bioavailability
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Optimized formulation properties for superior dissolution characteristics
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Excellent membrane permeability supporting effective oral absorption
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Consistent pharmacokinetic profile across production batches
4. Global Regulatory Compliance
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Documentation supports regulatory submissions worldwide
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Manufactured in facilities meeting international quality standards
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Comprehensive Certificate of Analysis with traceable batch records
5. Thermal and Chemical Stability
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Maintains structural integrity under standard storage conditions
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Resistant to degradation when properly stored
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Consistent performance throughout shelf life
6. Application Versatility
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Suitable for formulation into various dosage forms including tablets and capsules
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Compatible with common pharmaceutical excipients
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Supports both clinical development and commercial manufacturing
Therapeutic Applications
Upadacitinib API is specifically designed for development into finished dosage forms targeting:
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Rheumatoid arthritis
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Psoriatic arthritis
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Atopic dermatitis
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Other autoimmune conditions mediated by JAK-STAT signaling pathways
Quality Assurance
Our Upadacitinib API is produced under a comprehensive quality management system that includes:
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Strict raw material qualification procedures
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In-process controls at every manufacturing stage
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Final product testing against validated analytical methods
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Stability studies supporting recommended storage conditions
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Environmental monitoring of production areas
Global Distribution
Available for pharmaceutical manufacturers worldwide with full regulatory support documentation, including:
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Certificate of Analysis
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Stability data
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Material Safety Data Sheet (MSDS)
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Regulatory support files
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