Description

Edoxaban Impurity 9(1R,2S,4S) is a specific stereoisomeric impurity associated with the anticoagulant active pharmaceutical ingredient (API) Edoxaban. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Edoxaban-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Edoxaban Impurity 9 in Edoxaban API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and analyze impurities in Edoxaban.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial specifications.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings (e.g., FDA, EMA).
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Edoxaban.
• Research & Development: Aids in process chemistry research to understand and minimize the formation of this impurity during the synthesis of Edoxaban.

Basic Information

Product Name	Edoxaban Impurity 9(1R,2S,4S)
CAS No.	2024614-15-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 9; Edoxaban EP Impurity 9; Edoxaban USP Impurity 9; (1R,2S,4S)-Bicyclo[2.2.1]hept-5-ene-2-carboxylic acid, 5-(aminocarbonyl)-2-[(5-chloro-2-pyridinyl)amino]-, (1R,2S,4S)-isomer; Lixiana Impurity 9; Savaysa Impurity 9; DU-176b Impurity 9
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 9(1R,2S,4S) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment and handled with appropriate precautions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 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.