Description

Edoxaban Impurity 29 is a high-purity reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Edoxaban. This specific impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in API synthesis, method validation, and stability studies. The compound is supplied with comprehensive analytical data to support stringent quality assurance protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Edoxaban active pharmaceutical ingredient (API).
• Method Development and Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor and control impurity profiles.
• Stability Studies and Forced Degradation: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) and Batch Release Testing: A critical component in the routine QC testing of Edoxaban batches to ensure compliance with ICH guidelines and regulatory specifications.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Edoxaban Impurity 29
CAS No.	2244103-96-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 29; Edoxaban Process Impurity 29; Edoxaban Degradant 29; N-[5-Chloro-2-(2H-1,2,3-triazol-2-yl)phenyl]-4-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methoxy]benzamide; UNII-9K6F8YQ8JN; Edoxaban Impurity F; Edoxaban EP Impurity F
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 29 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, LC-MS, and NMR. The quality management adheres to cGMP principles, supporting its use in regulated pharmaceutical environments for research, development, and quality control applications.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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 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.