Description

Edoxaban Impurity 36 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Edoxaban. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the identification and quantification of specific impurities in Edoxaban active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this impurity under various stress conditions.
• Quality Control (QC) and Release Testing: Essential for routine batch analysis in QC laboratories to ensure Edoxaban batches meet stringent pharmacopeial (e.g., USP, EP) and ICH regulatory limits for impurities.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive understanding and control of the drug substance impurity profile.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and to refine purification processes for Edoxaban.

Basic Information

Product Name	Edoxaban Impurity 36
CAS No.	1807315-97-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 36; Edoxaban Impurity F; Edoxaban EP Impurity G; Edoxaban USP Impurity; 1-(5-Chlorothiophene-2-carbonyl)-L-leucyl-4-(pyridin-2-yl)piperazine impurity; Lixiana Impurity 36; Savaysa Impurity 36
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 36 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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