Description

Edoxaban Impurity 46 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes of the anticoagulant drug Edoxaban. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. 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 46 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling of Edoxaban.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring drug product consistency and compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Edoxaban.
• Research and Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Edoxaban Impurity 46
CAS No.	1932494-49-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 46; Edoxaban Impurity; Edoxaban Process Impurity; Edoxaban Degradant; N-[5-Chloro-2-(2H-tetrazol-5-yl)phenyl]-N'-[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]ethanediamide (IUPAC-based); Edoxaban Analog; Edoxaban Specified Impurity; Pharmaceutical Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 46 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.