Description

Dibotermin Alfa CAS NO 246539-15-1 is a recombinant human bone morphogenetic protein-2 (rhBMP-2) used as a potent osteoinductive agent. This high-purity protein is critical for stimulating bone formation and regeneration in clinical and research settings. It is primarily utilized by the pharmaceutical and advanced biotechnology sectors for the development of bone graft substitutes and orthopedic therapeutic applications.

Application

• Orthopedic Implants and Devices: Key active ingredient in absorbable collagen sponges and synthetic scaffolds for spinal fusion, fracture repair, and oral/maxillofacial surgeries.
• Bone Graft Substitute Formulations: Used in the development of osteoconductive matrices that promote new bone growth as an alternative to autografts.
• Biomedical Research: Essential tool for in vitro and in vivo studies of osteogenesis, bone cell differentiation, and skeletal tissue engineering.
• Regenerative Medicine: Investigated for use in advanced therapies aimed at repairing significant bone defects and non-unions.
• Pharmaceutical Development: Serves as the active pharmaceutical ingredient (API) in GMP-manufactured biologic products for orthopedic indications.

Basic Information

Product Name	Dibotermin Alfa
CAS No.	246539-15-1
Molecular Formula	C785H1223N217O235S8
Molecular Weight	Approx. 18,000 Da (Dimer)
Synonyms	Recombinant Human Bone Morphogenetic Protein-2; rhBMP-2; BMP-2; Bone Morphogenetic Protein 2; Osteogenic Protein; CBMP2A; BMP2A; BMP-2A; Dibotermin; InductOs® (proprietary product containing dibotermin alfa)
EINECS	Contact for details

Quality Control

Our Dibotermin Alfa is manufactured and tested under stringent quality systems to ensure it meets the exacting standards required for pharmaceutical and research applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, bioactivity, and impurity profiles. We adhere to relevant portions of ICH Q6B guidelines for biotechnology products, and GMP-grade material is available for advanced therapeutic development.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized material at -20°C or below. Once reconstituted, aliquot and store at -70°C to -80°C. Avoid repeated freeze-thaw cycles. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled, dry conditions.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (SDS-PAGE)	Corresponds to reference standard
Purity (RP-HPLC)	≥ 95.0%
Assay (Bioactivity)	≥ 1.5 x 106 units/mg
Endotoxin (LAL)	< 1.0 EU/µg
Protein Content (UV)	Contact for details
Residual Moisture (KF)	< 3.0%
Sterility (Membrane Filtration)	Sterile

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