Abrocitinib is an oral, small-molecule Janus kinase 1 selective inhibitor engineered for advanced dermatological formulations. Operating as a targeted immunomodulator, it suppresses specific inflammatory cytokine signaling pathways associated with chronic skin conditions. The synthetic route is optimized to achieve exceptional chemical purity and stable solid-state characteristics, ensuring reliable performance in downstream solid oral dosage manufacturing.
Technical Specifications
|
Technical Parameter |
Specification |
|
International Nonproprietary Name |
Abrocitinib |
|
Chemical Name |
Methyl N-{cis-4-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]cyclohexyl}sulfamide |
|
Structural Class |
Small Molecule / JAK Inhibitor |
|
Storage Conditions |
Store in tightly closed containers between 2°C and 8°C in a dry environment, protected from light |
Quality & Analytical Standards
|
Appearance |
White to off-white crystalline powder |
|
Identification |
Confirmed via infrared spectroscopy, high-performance liquid chromatography, and proton nuclear magnetic resonance |
|
Assay (Anhydrous Basis) |
99.0% to 101.0% |
|
Individual Specified Impurity |
Maximum 0.10% |
|
Total Impurities |
Maximum 0.5% |
|
Water Content |
Maximum 0.5% |
|
Residue on Ignition |
Maximum 0.1% |
|
Heavy Metals |
Maximum 10 ppm |
|
Residual Solvents |
Maximum 0.5% ethanol and acetone combined |
Manufacturing Capabilities
Gram scale to multi-ton commercial output
Validated industrial processing ensuring consistent chemical yield and impurity profiles
Nucleophilic substitution, catalytic hydrogenation, amidation, and controlled crystallization
Dedicated high-potency containment facilities utilizing advanced isolator technology
Regulatory Documentation
Certificate of Analysis: Provided with every manufactured batch against established pharmacopeial standards
Drug Master File: Complete chemistry, manufacturing, and controls documentation prepared for international regulatory submissions
Safety Data Sheet: Globally harmonized system compliant toxicity, handling, and storage protocols
Impurity Profile Report: Comprehensive toxicological evaluation of process-related impurities and genotoxic assessments available upon request
Stability Data: Real-time and accelerated stability profiles aligned with international climatic zones
Packaging Specifications
Inner Layer
Double-tied, low-density polyethylene pharmaceutical-grade bags (1 kg or 5 kg capacity)
Secondary Layer
Vacuum-sealed aluminum foil barrier bag for moisture and light protection
Outer Layer
Fiber drums equipped with tamper-evident security seals (25 kg net weight)
Pharmaceutical Applications
Oral Tablet Core Formulation
Controlled particle size distribution ensures uniform powder blending and reliable direct compression performance.
Controlled-Release Systems
High chemical stability supports compatibility with functional polymer coatings for extended-release delivery.
Pre-Clinical Studies
High-purity material suitable for in vitro and in vivo pharmacokinetic, metabolic, and bioavailability evaluations.
Scale-Up Transfer
Well-characterized synthetic pathways facilitate seamless technical transfer from pilot scale to commercial production.
FAQ
Q: What is the current regulatory status for this API?
A: A complete Drug Master File containing comprehensive chemistry, manufacturing, and controls data is available to support global filings.
Q: How are genotoxic risks managed?
A: All synthetic byproducts and potential impurities are monitored using validated chromatographic methods to maintain levels well below established safety thresholds.
Q: Can particle size distribution be customized?
A: Mechanical micronization parameters can be adjusted prior to final packaging to meet precise dissolution and flow requirements.
Q: What are the shipping protocols?
A: Shipments utilize thermal-barrier packaging equipped with continuous temperature loggers to maintain specified environmental parameters during transit.
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