Active Pharmaceutical Ingredient

Ruxolitinib

Also known as: Jakafi API; Ruxolitinib Phosphate

CAS: 941678-49-5 Kinase Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Ruxolitinib API — Mediocon Inc
Ruxolitinib — Pharmaceutical Grade API

Product Overview

CAS No: 941678-49-5  |  MF: C₁₇H₁₈N₆  |  MW: 306.37 g/mol

Ruxolitinib is a selective JAK1 and JAK2 inhibitor and active pharmaceutical ingredient used in the treatment of myelofibrosis and polycythemia vera. Mediocon Inc supplies high-purity Ruxolitinib API conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Ruxolitinib inhibits the Janus kinase signaling pathway (JAK-STAT), reducing cytokine-mediated proliferation and survival signals implicated in myeloproliferative neoplasms. It is also approved for atopic dermatitis (topical form) and steroid-refractory graft-versus-host disease (GvHD).

Key Features

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

Applications

  • Myelofibrosis treatment
  • Polycythemia vera management
  • Graft-versus-host disease (GvHD)
  • Atopic dermatitis (topical formulations)

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 NameRuxolitinib
Also Known AsJakafi API; Ruxolitinib Phosphate
CAS Number941678-49-5
Molecular FormulaC₁₇H₁₈N₆
Molecular Weight306.37 g/mol
CategoryJAK1/JAK2 Inhibitor — Kinase Inhibitor
AppearanceWhite to off-white powder
SolubilitySlightly soluble in water; soluble in DMSO, methanol
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
Packing25 kg HDPE drums / as per requirement
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