Description

Azilsartan Impurity 10 is a specified organic impurity associated with the active pharmaceutical ingredient (API) Azilsartan medoxomil. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Azilsartan-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Azilsartan medoxomil API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization.
• Stability Studies: Used to track the formation of degradation products under various stress conditions.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Azilsartan to minimize impurity formation.

Basic Information

Product Name	Azilsartan Impurity 10
CAS No.	139481-40-6
Molecular Formula	C25H20N4O5
Molecular Weight	456.45 g/mol
Synonyms	2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylic Acid; Azilsartan Related Compound; Azilsartan Medoxomil Impurity; (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylate Impurity; TAK-491 Impurity; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity 10 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, aligning with ICH guidelines and current Good Manufacturing Practices (cGMP). A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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