Description

Ustekinumab CAS NO 815610-63-0 is a fully human monoclonal antibody that specifically targets the p40 subunit of the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). This targeted mechanism of action makes it a critical active pharmaceutical ingredient (API) for the treatment of immune-mediated inflammatory diseases. It is essential for pharmaceutical manufacturers developing advanced biologic therapies for conditions such as plaque psoriasis, psoriatic arthritis, and Crohn's disease.

Application

• Primary Active Pharmaceutical Ingredient (API) for the formulation of biologic therapeutics.
• Manufacturing of injectable solutions for the treatment of moderate-to-severe plaque psoriasis.
• Production of therapies for active psoriatic arthritis in adult patients.
• Key component in medicines for moderately to severely active Crohn's disease.
• Used in clinical research and development of novel immunology treatments.
• Reference standard for analytical method development and quality control in biopharmaceutical labs.

Basic Information

Product Name	Ustekinumab
CAS No.	815610-63-0
Molecular Formula	C6484H10004N1732O2016S44
Molecular Weight	Approx. 148.6 kDa
Synonyms	CNTO 1275; Anti-IL-12/IL-23 p40 monoclonal antibody; STELARA (brand name); Ustekinumab-aekn; IL12/IL23p40 Monoclonal Antibody; Immunoglobulin G1, anti-(human interleukin 12 subunit p40 and interleukin 23 subunit p40) (human-mouse monoclonal CNTO 1275 γ1-chain), disulfide with human-mouse monoclonal CNTO 1275 κ-chain, dimer
EINECS	Contact for details

Quality Control

Our Ustekinumab is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting the stringent requirements for a biologic API. Certificates of Analysis (COA) are provided, detailing specifications for appearance, protein content, biological activity, purity by SEC-HPLC, host cell proteins, and endotoxin levels.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C to -70°C. Avoid repeated freeze-thaw cycles. Under these conditions, the product remains stable for the duration indicated on the certificate of analysis. This material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Protein Content (A280)	95.0 - 105.0% of label claim
Biological Activity (Cell-based assay)	Within defined potency range
Host Cell Proteins (HCP)	< 100 ppm
Endotoxin	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile

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