Description

Edoxaban Impurity 45 is a high-purity chemical reference standard used in the analytical profiling and quality control of the anticoagulant active pharmaceutical ingredient (API), Edoxaban. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the production of Edoxaban-based medications.

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 & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to ensure batch-to-batch consistency and purity of the final drug product.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop robust purification processes for Edoxaban.

Basic Information

Product Name	Edoxaban Impurity 45
CAS No.	1932332-14-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 45; Edoxaban Impurity; Edoxaban Degradant; Savaysa Impurity 45; Lixiana Impurity 45; DU-176b Impurity 45; (S)-N-(5-Chloropyridin-2-yl)-2-((4-(N-((2S,3R)-1-(3-(N-(2-(3,6-dihydro-2H-pyran-4-yl)ethyl)carbamimidoyl)phenyl)-3-methoxy-2-(pyridin-2-yl)butanamido)methyl)phenyl)amino)-2-oxoacetamide (long-form IUPAC-based name); Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 45 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment to support your regulatory and quality needs.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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