Description

Edoxaban Impurity 42 is a designated process-related impurity or degradation product of the anticoagulant active pharmaceutical ingredient (API) Edoxaban. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity. It is an essential material for analytical method development and validation, stability studies, and regulatory compliance documentation. Pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories require this compound to ensure the safety, efficacy, and purity of Edoxaban-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative analysis of Edoxaban Impurity 42 in API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and forced degradation studies.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation kinetics of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data and characterization for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the Edoxaban synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Edoxaban Impurity 42
CAS No.	1824205-91-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 42; Edoxaban EP Impurity G; Edoxaban USP Impurity; N-[5-Chloro-2-[[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[[5-methyl-2-oxo-3H-1,3-oxazol-4-yl)methyl]amino]cyclohexyl]amino]-4-pyridinyl]carbonyl]-N2-[(1S,2R)-1-(hydroxymethyl)-2-phenylpropyl]-L-α-aspartamide; Edoxaban Degradant; Edoxaban Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 42 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, LC-MS, NMR, and IR spectroscopy to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including assay purity, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in GMP-regulated environments.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under inert atmosphere or in a desiccator.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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