Description

Fondaparinux is a synthetic, selective, and potent anticoagulant agent that functions as a factor Xa inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for the development of safe and effective antithrombotic medications. It is primarily utilized by pharmaceutical manufacturers and research institutions in the production of injectable therapeutics for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Application

• Pharmaceutical API: Primary active ingredient in the formulation of injectable anticoagulant drugs.
• Thrombosis Prevention: Used in medications for preventing venous thromboembolism (VTE) following major orthopedic surgeries like hip or knee replacement.
• Thrombosis Treatment: Serves as a key component in therapies for the acute treatment of conditions such as deep vein thrombosis (DVT).
• Research & Development: Essential reference standard and building block in cardiovascular and hematology research for studying coagulation pathways.
• Biosimilar Development: Critical raw material for companies developing generic or biosimilar versions of branded fondaparinux sodium products.
• Drug Delivery Systems: Investigated for incorporation into novel delivery mechanisms to improve pharmacokinetic profiles.

Basic Information

Product Name	Fondaparinux
CAS No.	816468-88-9
Molecular Formula	C31H43N3O49S8
Molecular Weight	1728.0 g/mol
Synonyms	Fondaparinux Sodium; SR 90107A; Org 31540; Pentasaccharide (Fondaparinux); Methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-β-D-glucopyranuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-2-O-sulfo-α-L-idopyranuronosyl-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt; Arixtra (Brand Name); Synthetic Pentasaccharide
EINECS	Contact for details

Quality Control

Our Fondaparinux is manufactured under strict quality systems to ensure it meets the stringent requirements for pharmaceutical actives. Each batch is tested against comprehensive specifications, including identity, purity, potency, and impurity profiles using advanced analytical techniques like HPLC. We provide full traceability and support regulatory filings with detailed documentation. Certificates of Analysis (COA) are available for every batch upon request, confirming compliance with relevant pharmacopeial standards (e.g., USP, EP) and internal specifications.

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) and must be kept under dry conditions to maintain stability and potency. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Specific Optical Rotation	Contact for details
pH (Solution)	5.0 - 7.5
Bacterial Endotoxins	< 0.1 EU/mg
Sterility (if applicable)	Sterile

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