Description

Edoxaban Impurity 29 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticoagulant drug Edoxaban. This compound is critical for ensuring drug safety and efficacy by serving as a benchmark for identifying and quantifying process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, supporting compliance with stringent regulatory requirements from agencies like the FDA and EMA.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Edoxaban active pharmaceutical ingredient (API) and finished dosage forms.
• Critical component in analytical method development and validation for HPLC, UPLC, and LC-MS systems.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Edoxaban.
• Essential for regulatory compliance and filing, providing necessary data for drug master files (DMFs) and regulatory submissions.
• Supports quality control (QC) laboratories in pharmaceutical manufacturing for routine batch release testing.
• Valuable for academic and contract research organizations (CROs) conducting research on novel anticoagulant therapies.

Basic Information

Product Name	Edoxaban Impurity 29
CAS No.	852291-42-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Edoxaban Related Compound 29; Edoxaban EP Impurity J; Edoxaban USP Impurity; N-[5-(Aminomethyl)-2-pyridinyl]-4-[[(1,3-thiazol-2-ylamino)carbonyl]amino]benzenesulfonamide (proposed); Savaysa Impurity 29; Lixiana Impurity 29; DU-176b Impurity
EINECS	Contact for details

Quality Control

Every batch of Edoxaban Impurity 29 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmacopeial standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with cGMP, ICH Q3A/B, and ISO 17034 guidelines for reference material producers.

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 in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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