Description

Edoxaban Impurities CAS NO 1255529-34-0 refers to a specific chemical impurity associated with the active pharmaceutical ingredient Edoxaban, a direct Factor Xa inhibitor. This compound is critical for pharmaceutical research and development, serving as a reference standard for quality control and analytical method validation. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, purification, and regulatory compliance of Edoxaban-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Edoxaban drug substance and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with strict pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker to track the formation of degradation products under various stress conditions (heat, light, humidity) during drug product shelf-life studies.
• Process Chemistry & Optimization: Used by chemical engineers and synthetic chemists to identify and eliminate process-related impurities, improving the yield and purity of the final Active Pharmaceutical Ingredient (API).
• Regulatory Submissions: Provides essential data and characterization for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug's impurity profile.

Basic Information

Product Name	Edoxaban Impurities
CAS No.	1255529-34-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound; Edoxaban Specified Impurity; Edoxaban Process Impurity; Edoxaban Degradant; Edoxaban Reference Standard; Factor Xa Inhibitor Impurity; DU-176b Impurity
EINECS	Contact for details

Quality Control

Our Edoxaban Impurities are produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, LC-MS, and NMR, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for pharmaceutical impurities.

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 desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.