Description

Edoxaban Impurity 22 (1S,2R,4R) 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 material 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 related substances in Edoxaban API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods (e.g., HPLC, UPLC) to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Edoxaban.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during Edoxaban manufacturing.

Basic Information

Product Name	Edoxaban Impurity 22 (1S,2R,4R)
CAS No.	2024614-32-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 22; (1S,2R,4R)-Isomer of Edoxaban Impurity; DU-176b Impurity 22; Lixiana Impurity 22; Savaysa Impurity 22; (1S,2R,4R)-5-Chloro-N-((2S,5R)-2-(5-(cyclopropylcarbamoyl)-2,6-dihydroxypyrimidin-4-yl)-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl)-1-(2,3-dihydro-1H-inden-5-yl)-1H-pyrazole-4-carboxamide
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 22 (1S,2R,4R) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, chiral purity confirmation, and identity verification (IR, MS) 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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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