Description

Edoxaban Impurity 35 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 during analysis. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Edoxaban Impurity 35 in active pharmaceutical ingredient (API) and finished drug product batches.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity profiles and ensure batch-to-batch consistency of Edoxaban API, supporting compliance with ICH Q3A and Q3B guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Edoxaban under various environmental conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., to FDA, EMA) to establish impurity thresholds and demonstrate comprehensive control of the drug substance.
• Research and Development: Supports process chemistry research to understand the formation, fate, and purge of this specific impurity during the synthesis and purification of Edoxaban.

Basic Information

Product Name	Edoxaban Impurity 35
CAS No.	2081883-57-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 35; Edoxaban EP Impurity G; Edoxaban USP Impurity; Edoxaban Process Impurity; N-[5-Chloro-2-(2H-tetrazol-5-yl)phenyl]-4-(ethoxymethyl)-5-methyl-2-oxo-1-[4-(trifluoromethyl)phenyl]-1,2-dihydropyridine-3-carboxamide; UNII-9G2F3T8V3R; Edoxaban Impurity G (EP); Edoxaban Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 35 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, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Handle the material under appropriate laboratory conditions to prevent contamination.

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 unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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