Description

Fondaparinux Sodium Impurity CAS NO 1809833-99-5 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 enabling the identification and quantification of related impurities during pharmaceutical development and manufacturing. It is an essential material for analytical chemists, quality control laboratories, and R&D departments within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Fondaparinux Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research & Development: Utilized in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the main API.

Basic Information

Product Name	Fondaparinux Sodium Impurity
CAS No.	1809833-99-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fondaparinux Related Compound; Fondaparinux Sodium EP Impurity; Fondaparinux Process Impurity; Fondaparinux Degradant; Arixtra Impurity; Synthetic Pentasaccharide Impurity; Anticoagulant Impurity Standard; Heparinoid Impurity
EINECS	Contact for details

Quality Control

Every batch of Fondaparinux Sodium Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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