Description

Fondaparinux Sodium Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the anticoagulant drug Fondaparinux Sodium by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in quality control and research and development of synthetic heparin pentasaccharides.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Fondaparinux Sodium Active Pharmaceutical Ingredient (API) and finished drug products.
• Critical component in analytical method development and validation (e.g., HPLC, LC-MS) for compliance with ICH Q3A/B guidelines.
• Used in stability studies to monitor degradation pathways and establish shelf-life specifications for Fondaparinux Sodium.
• Essential for pharmaceutical research to understand the synthesis pathway, by-products, and purification processes of the parent drug.
• Serves as a quality control benchmark in manufacturing to ensure batch-to-batch consistency and meet pharmacopeial standards (USP, EP).

Basic Information

Product Name	Fondaparinux Sodium Impurity 1
CAS No.	348625-84-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fondaparinux Sodium Related Compound 1; Fondaparinux Impurity A; Fondaparinux EP Impurity A; Fondaparinux Sodium Process Impurity; Methyl O-(2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl)-(1→4)-O-(β-D-glucopyranosyluronic acid)-(1→4)-O-(2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl)-(1→4)-O-(2-O-sulfo-α-L-idopyranosyluronic acid)-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt; Arixtra Impurity 1; SR90107A Impurity
EINECS	Contact for details

Quality Control

Our Fondaparinux Sodium Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with every shipment to support your regulatory and quality documentation.

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 purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	90.0% - 110.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH limits

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