Description

Edoxaban Impurity 21 is a designated impurity reference standard used in the analytical profiling and quality control of the anticoagulant active pharmaceutical ingredient (API) Edoxaban. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Edoxaban Impurity 21 in Edoxaban API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure compliance with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines on impurities in new drug substances.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish drug shelf-life.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in process chemistry research to understand and control the formation pathways of this impurity during API synthesis.

Basic Information

Product Name	Edoxaban Impurity 21
CAS No.	480449-28-3
Molecular Formula	C24H30ClN7O4
Molecular Weight	515.99 g/mol
Synonyms	Edoxaban Related Compound 21; Edoxaban EP Impurity J; Edoxaban USP Impurity 21; 1-(4-Carbamimidoylbenzyl)-5-chloro-3-(5,6,7,8-tetrahydro-1,8-naphthyridin-2-yl)-1H-indole-2-carboxylic acid; Lixiana Impurity 21; Savaysa Impurity 21; DU-176b Impurity 21; (2-Carboxy-5-chloro-3-(5,6,7,8-tetrahydro-1,8-naphthyridin-2-yl)-1H-indol-1-yl)methyl]benzene-4-carboximidamide
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 21 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, typically determined by validated HPLC/LC-MS methods. We support compliance with ICH Q3A/B guidelines and can provide materials suitable for use in methods aligned with USP and EP monographs.

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 material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (Mass Spectrometry)	Consistent with molecular structure
Purity (HPLC, Area %)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.