Description

Tofacitinib CAS NO 477600-75-2 is a potent and selective Janus kinase (JAK) inhibitor, representing a significant advancement in targeted immunomodulatory therapy. This small molecule pharmaceutical intermediate is critical for the development and production of innovative treatments for autoimmune and inflammatory conditions. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the synthesis of novel therapeutics for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Core intermediate in the commercial manufacturing of tofacitinib citrate, the active component in prescription medications.
• Pharmaceutical Research & Development: Serves as a key building block in medicinal chemistry for developing new JAK inhibitor analogs and next-generation immunomodulators.
• Reference Standard: Used as a high-purity standard in analytical laboratories for quality control (QC) and quality assurance (QA) testing of finished drug products.
• Preclinical Studies: Employed in pharmacological and toxicological research to investigate mechanisms of action and therapeutic efficacy.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for scale-up and commercial production runs.
• Regulatory Filings: Provides the necessary chemical entity for documentation in regulatory submissions to agencies like the FDA and EMA.

Basic Information

Product Name	Tofacitinib
CAS No.	477600-75-2
Molecular Formula	C16H20N6O
Molecular Weight	312.37 g/mol
Synonyms	Tofacitinib Free Base; CP-690550; Tasocitinib; 3-((3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile; Xeljanz Intermediate; JAK3 Inhibitor
EINECS	Contact for details

Quality Control

Our Tofacitinib is manufactured under strict quality management systems to ensure batch-to-batch consistency and high purity. Each lot undergoes comprehensive analytical testing, including HPLC for assay and related substances, residual solvent analysis, and identification by spectroscopic methods. A Certificate of Analysis (COA) detailing all test results is provided with every shipment. We adhere to cGMP (current Good Manufacturing Practice) standards suitable for pharmaceutical intermediate production.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions (e.g., nitrogen atmosphere) in a desiccator after opening to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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