Active Pharmaceutical Ingredient

Tofacitinib

Also known as: Xeljanz; CP-690550

CAS: 477600-75-2JAK Inhibitor / APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Tofacitinib API — Mediocon Inc
Tofacitinib — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 477600-75-2  |  MF: C₁₆H₂₀N₆O  |  MW: 312.37 g/mol

Tofacitinib is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Tofacitinib is a potent Janus kinase (JAK) inhibitor that selectively inhibits JAK1 and JAK3. It is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and active ankylosing spondylitis.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Rheumatoid arthritis treatment
  • Psoriatic arthritis management
  • Ulcerative colitis therapy
  • Ankylosing spondylitis treatment

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameTofacitinib
Also Known AsXeljanz; CP-690550
CAS Number477600-75-2
Molecular FormulaC₁₆H₂₀N₆O
Molecular Weight312.37 g/mol
CategoryJAK Inhibitor / Active Pharmaceutical Ingredient
AppearanceWhite to off-white crystalline powder
SolubilitySoluble in DMSO and methanol; slightly soluble in water
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.TOF/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
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