Active Pharmaceutical Ingredient

Ustekinumab

Also known as: Stelara; CNTO 1275

CAS: 815610-63-0Biologic APIMonoclonal AntibodyIL-12 / IL-23 InhibitorIP / BP / EP / USPGMP CertifiedAurangabad, India
Ustekinumab API — Mediocon Inc
Ustekinumab — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 815610-63-0  |  MF: Human monoclonal antibody (IgG1κ)  |  MW: ~148,079 Da

Ustekinumab 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.

Ustekinumab is a fully human monoclonal antibody (IgG1κ) that binds to the p40 subunit shared by interleukins IL-12 and IL-23, blocking their interaction with IL-12Rβ1. It is approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Key Features

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

Applications

  • Plaque psoriasis treatment
  • Psoriatic arthritis management
  • Crohn's disease therapy
  • Ulcerative colitis 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 NameUstekinumab
Also Known AsStelara; CNTO 1275
CAS Number815610-63-0
Molecular FormulaHuman monoclonal antibody (IgG1κ)
Molecular Weight~148,079 Da
CategoryMonoclonal Antibody / Biologic API
AppearanceWhite to off-white lyophilised powder / solution
SolubilitySoluble in aqueous buffer; formulated with polysorbate 80 and L-histidine
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.UST/24033044
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
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