Description

Edoxaban Impurity 12 (1R,2R,4S) is a specific stereoisomeric impurity associated with the anticoagulant active pharmaceutical ingredient (API) Edoxaban. This compound is of critical importance in pharmaceutical development and manufacturing for ensuring drug safety, efficacy, and regulatory compliance. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for use as a certified reference standard in analytical method development, validation, and quality control processes.

Application

• Pharmaceutical Reference Standard: Serves as a high-purity certified standard for the identification and quantification of impurities in Edoxaban API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive and specific chromatographic methods (e.g., HPLC, UPLC) to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Edoxaban products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Edoxaban.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive control over the drug substance's impurity profile.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Edoxaban Impurity 12 (1R,2R,4S)
CAS No.	500572-10-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 12; (1R,2R,4S)-Isomer of Edoxaban Impurity; DU-176b Impurity 12; 1-(4-((5-Chloro-2-((((1R,2R,4S)-4-((hexyloxy)carbonyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)cyclopentyl)carbamoyl)-1H-imidazol-5-yl)oxy)phenyl)-3-(2-hydroxyethyl)urea; (1R,2R,4S)-4-((Hexyloxy)carbonyl)-N-(5-((4-(3-(2-hydroxyethyl)ureido)phenoxy)methyl)-1-methyl-1H-pyrazole-3-carbonyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)cyclopentanecarboxamide isomer.
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 12 (1R,2R,4S) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and strength. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data (HPLC/UPLC) for traceability and compliance. The product is suitable for use under current Good Manufacturing Practice (cGMP) guidelines and supports compliance with ICH, USP, and EP standards.

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) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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