Description

Azilsartan Impurity 36 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Azilsartan. This compound is critical for ensuring the purity, safety, and efficacy of Azilsartan-based antihypertensive medications through precise identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Azilsartan Impurity 36 in Azilsartan API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with strict pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Aids in synthetic route optimization and impurity profiling during the drug development lifecycle.

Basic Information

Product Name	Azilsartan Impurity 36
CAS No.	1499167-76-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound 36; Azilsartan EP Impurity 36; Azilsartan USP Impurity 36; 2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylic acid (related structure); TAK-536 Impurity 36; Edarbi Impurity 36; Azilsartan Kamedoxomil Impurity 36
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity 36 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization to ensure high purity and accurate identification, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%

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