Description

Defibrotide is a complex mixture of single-stranded oligonucleotides derived from porcine intestinal mucosa, known for its potent antithrombotic and profibrinolytic properties. This active pharmaceutical ingredient is critical for its ability to protect and restore endothelial cell function, making it a vital therapeutic agent. It is primarily required by the pharmaceutical industry for the formulation of life-saving medications, specifically for the treatment of severe hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem cell transplantation.

Application

• Pharmaceutical API: Primary active ingredient in injectable formulations for the treatment of severe hepatic veno-occlusive disease (VOD).
• Hematology/Oncology Therapeutics: Used in drugs administered to pediatric and adult patients post-hematopoietic stem cell transplantation (HSCT).
• Endothelial Protection: Serves in research and development of therapies targeting endothelial damage and microvascular thrombosis.
• Antithrombotic Agent: Investigated for applications in other thrombotic disorders due to its unique mechanism of action.
• GMP Manufacturing: Supplied as a high-purity raw material for cGMP-compliant drug product manufacturing.
• Clinical Research: Utilized as a reference standard or active component in preclinical and clinical studies for new indications.

Basic Information

Product Name	Defibrotide
CAS No.	83712-60-1
Molecular Formula	Mixture of oligonucleotides (C10H12N5O7P)n
Molecular Weight	Average molecular weight ~ 15-30 kDa
Synonyms	Defibrotide Sodium; Polydeoxyribonucleotide Sodium Salt; PDRN; Defitelio® (brand name); Oligodeoxyribonucleotide Sodium Salt; Deoxyribonucleic Acid Sodium Salt from Porcine Intestine; DNA Sodium Salt (Polynucleotide); 5'-d(Purine/Pyrimidine) Oligonucleotides Sodium Salt
EINECS	Contact for details

Quality Control

Our Defibrotide is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is tested to meet stringent specifications for identity, purity, potency, and impurities, ensuring compliance with relevant pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for key parameters such as assay, molecular weight distribution, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	NLT 90.0% and NMT 110.0%
Molecular Weight Distribution	Specified range (e.g., 15-30 kDa)
Protein Content	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Bacterial Endotoxins	NMT specified limit per mg
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13
Water Content (KF)	NMT 5.0%

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