Description

Tofacitinib Citrate CAS NO 540737-29-9 is the citrate salt form of tofacitinib, a potent and selective Janus kinase (JAK) inhibitor. This active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted immunomodulatory therapies. It is primarily required by pharmaceutical companies and research institutions engaged in the production of innovative treatments for autoimmune and inflammatory diseases, ensuring a reliable supply of high-purity material is paramount for drug development and regulatory compliance.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of oral medications for the treatment of autoimmune conditions.
• Rheumatoid Arthritis (RA) Therapy: Key component in drugs targeting moderate to severe RA, inhibiting JAK pathways to reduce inflammation and halt disease progression.
• Psoriatic Arthritis Treatment: Used in therapies for active psoriatic arthritis, providing an alternative mechanism of action for patients.
• Ulcerative Colitis Medication: Essential for manufacturing treatments for moderately to severely active ulcerative colitis.
• Research & Development: Critical reference standard and building block in preclinical and clinical research for novel JAK inhibitor-based therapies.
• Generic Drug Manufacturing: Serves as the core API for companies developing bioequivalent versions of approved JAK inhibitor drugs.
• Dosage Form Development: Used in the R&D of various dosage forms, including tablets and other solid oral formulations.

Basic Information

Product Name	Tofacitinib Citrate
CAS No.	540737-29-9
Molecular Formula	C22H28N6O · C6H8O7
Molecular Weight	504.49 g/mol (for citrate salt)
Synonyms	Tofacitinib citrate; CP-690550 citrate; Tasocitinib citrate; 3-((3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile citrate; Xeljanz® API; Citrate salt of tofacitinib; JAK inhibitor CP-690550 citrate
EINECS	Contact for details

Quality Control

Our Tofacitinib Citrate is manufactured under strict quality management systems. Each batch undergoes 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 for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and purity. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details
pH (in solution)	Contact for details

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