Description

Denosumab is a fully human monoclonal antibody (IgG2) that acts as a RANKL inhibitor, specifically binding to and neutralizing the RANK ligand. This mechanism is critical for its role in inhibiting osteoclast formation, function, and survival, thereby reducing bone resorption. It is a vital active pharmaceutical ingredient (API) for the formulation of targeted biologic therapies. This product is essential for pharmaceutical manufacturers and research institutions developing treatments for conditions involving excessive bone loss, such as osteoporosis and bone metastases.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of biologic osteoporosis treatments (e.g., Prolia®).
• Key component in therapies for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.
• Research and development of novel biologics targeting the RANK/RANKL/OPG pathway.
• Production of biosimilar versions of established denosumab-based therapeutics.
• Use in preclinical and clinical studies investigating bone biology and metabolic bone diseases.
• Formulation development for injectable biologic drug products requiring high purity and stability.

Basic Information

Product Name	Denosumab
CAS No.	615258-40-7
Molecular Formula	C6404H9872N1696O1997S44
Molecular Weight	Approx. 144,700 Da
Synonyms	AMG 162; Immunoglobulin G2, anti-(human RANKL) (human monoclonal AMG 162 γ2-chain), disulfide with human monoclonal AMG 162 κ-chain, dimer; Prolia (trade name); Xgeva (trade name); RANKL inhibitor; Anti-RANKL monoclonal antibody
EINECS	Contact for details

Quality Control

Our Denosumab is manufactured and tested under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical active ingredients. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, potency, and impurity profiles. We adhere to relevant ICH guidelines and can supply material suitable for use under cGMP (Current Good Manufacturing Practice) conditions for advanced therapeutic applications.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C or below. Avoid repeated freeze-thaw cycles. Under these conditions, the product remains stable for the duration specified on the certificate of analysis.

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)
Potency (Cell-based assay)	90% - 110% of reference
Protein Content	As per COA
Endotoxin	< 1.0 EU/mg
Host Cell Protein	< 100 ppm
Residual DNA	< 10 pg/mg

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