Description

Edoxaban Impurity 32 is a high-purity chemical reference standard used in the analytical profiling and quality control of the anticoagulant active pharmaceutical ingredient (API), Edoxaban. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and routine batch testing within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Edoxaban Impurity 32 in Edoxaban API and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies of Edoxaban to understand degradation pathways.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in synthetic chemistry research to study the formation and fate of this specific impurity during the API manufacturing process.

Basic Information

Product Name	Edoxaban Impurity 32
CAS No.	1461714-66-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 32; Edoxaban EP Impurity G; Edoxaban USP Impurity; (2R,4R)-1-(2-Hydroxyethyl)-4-[N-[4-[(5-Chloro-2-thienyl)carbonyl]amino]phenyl]methyl]-2-piperidinecarboxylic Acid Ethyl Ester; Edoxaban Process Impurity; DU-176b Impurity; Lixiana Impurity
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 32 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

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% w/w

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