Description

Edoxaban Impurity 37 is a high-purity chemical reference standard specifically identified as a process-related impurity of the anticoagulant drug Edoxaban. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities during drug substance manufacturing to ensure final product safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting activities in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the qualitative and quantitative analysis of Edoxaban and its related substances.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing of Edoxaban Active Pharmaceutical Ingredient (API) and finished drug products to monitor impurity levels against ICH guidelines.
• Regulatory Submission Support: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity understanding and control.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress and long-term storage conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Edoxaban Impurity 37
CAS No.	2081883-50-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 37; Edoxaban Impurity; Edoxaban Process Impurity; UNII-Contact for details; (Specific IUPAC name - Contact for details)
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 37 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and other critical quality attributes. Our quality standards align 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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere if the compound is determined to be easily oxidized.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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