Description

Edoxaban Impurity 30 is a designated impurity of the anticoagulant drug Edoxaban, identified by the CAS number 2089454-69-1. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance and product manufacturing. It is an essential material for analytical chemists and quality control professionals in the pharmaceutical industry, supporting method validation, stability studies, and regulatory compliance for generic and innovator drug development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Edoxaban and its related substances.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing of Edoxaban Active Pharmaceutical Ingredient (API) and finished dosage forms to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to identify and track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity, helping to optimize synthesis and purification processes to minimize its presence.

Basic Information

Product Name	Edoxaban Impurity 30
CAS No.	2089454-69-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 30; Edoxaban EP Impurity 30; Edoxaban USP Impurity 30; Edoxaban Process Impurity; N-[5-Chloropyridin-2-yl]-2-[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]acetamide (proposed); Lixiana Impurity 30; Savaysa Impurity 30; DU-176b Impurity
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 30 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, MS, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting traceability and compliance with cGMP and ICH guidelines.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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% Any individual unknown impurity ≤ 1.0%
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.