Description

Edoxaban Impurity 44 is a designated impurity of the anticoagulant pharmaceutical Edoxaban, a direct Factor Xa inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring the purity, safety, and efficacy of Edoxaban drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Edoxaban.
• Method Development and Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to detect and quantify this specific impurity.
• Quality Control (QC) Testing: Employed in routine QC testing of Edoxaban Active Pharmaceutical Ingredient (API) and finished dosage forms to monitor impurity profiles.
• Stability Studies: Used to identify and track the formation of degradation products in Edoxaban under various stress conditions.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Process Chemistry Research: Aids in the optimization of Edoxaban synthesis by identifying and controlling process-related impurities.

Basic Information

Item	Details
Product Name	Edoxaban Impurity 44
CAS No.	1461718-78-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 44; Edoxaban Impurity; Edoxaban EP Impurity 44; Edoxaban USP Impurity; Factor Xa Inhibitor Impurity; Lixiana Impurity; Savaysa Impurity; 1461718-78-4
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 44 is produced under a strict quality management system. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis and spectroscopic characterization (NMR, MS), to ensure identity and quality. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specified standards. We support compliance with ICH Q3A/B guidelines for impurities in new drug substances and products.

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. For long-term storage, keep the material in a cool, dry place. Handle and store in accordance with good laboratory practices.

Specification

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

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