Description

Edoxaban Impurity 19 (1S,2R,4S) Mesylate is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anticoagulant drug Edoxaban. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams involved in the development and manufacturing of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Edoxaban API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure drug substance and product specifications are met.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation of degradation products in Edoxaban under various stress conditions (e.g., heat, humidity, light).
• Research & Process Chemistry: Aids in understanding the synthesis pathway and purification processes for Edoxaban, helping to minimize impurity formation.

Basic Information

Product Name	Edoxaban Impurity 19 (1S,2R,4S) Mesylate
CAS No.	1807315-98-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 19; (1S,2R,4S)-Isomer of Edoxaban Mesylate Impurity; Edoxaban Mesylate Stereoisomer Impurity; Edoxaban Process Impurity; Lixiana Impurity; Savaysa Impurity; N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[5-methyl-6,7-dihydro-4H-thiazolo[5,4-c]pyridine-2-carbonyl]amino]cyclohexyl]ethanediamide Methanesulfonate
EINECS	Contact for details

Quality Control

Our Edoxaban Impurity 19 (1S,2R,4S) Mesylate is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using advanced techniques like HPLC, LC-MS, and NMR to confirm identity and purity. We provide full traceability and a detailed Certificate of Analysis (COA) with each shipment, ensuring compliance with the stringent requirements of pharmaceutical impurity 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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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