Description

Edoxaban Impurity 38 is a high-purity chemical reference standard used in the development and quality control of the anticoagulant pharmaceutical, Edoxaban. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) focused on cardiovascular therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Edoxaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (e.g., HPLC, UPLC) for the precise separation and detection of Edoxaban and its related substances.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies as per ICH guidelines.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Edoxaban formulations under various stress conditions (e.g., heat, humidity, light).
• Pharmacopoeial Testing: Supports testing to meet the specifications outlined in pharmacopoeias such as USP, EP, or JP for Edoxaban-related compounds.
• Process Chemistry Research: Used by chemists to study and optimize the synthesis pathway of Edoxaban, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Edoxaban Impurity 38
CAS No.	2081883-53-4
Molecular Formula	C24H30ClN7O4
Molecular Weight	515.99 g/mol
Synonyms	Edoxaban Related Compound 38; Edoxaban EP Impurity G; Edoxaban USP Impurity; 5-Chloro-N-(((5S)-2-oxo-3-(4-(3-oxomorpholino)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide; UNII-7Q9F1K3V1P; Lixiana Impurity 38; Savaysa Impurity 38; DU-176b Impurity
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 38 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical impurity reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Keep the container sealed to protect the material from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%
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.