Description

Azilsartan Impurity 5 is a specified organic impurity associated with the active pharmaceutical ingredient Azilsartan medoxomil. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in the development and production of antihypertensive medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Azilsartan medoxomil and related drug substances.
• Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor impurities in drug substances and products.
• Stability Indicating Studies: Employed in forced degradation and stability studies to identify and quantify degradation products, ensuring drug product shelf-life and safety.
• Quality Control and Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria in the routine quality control of pharmaceutical batches.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance.
• Research and Development: Used in R&D to study the degradation pathways and chemical behavior of Azilsartan under various conditions.

Basic Information

Product Name	Azilsartan Impurity 5
CAS No.	1857365-17-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound 5; Azilsartan Medoxomil Impurity 5; 2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic Acid (putative); UNII-9K8Q4W6K1F; BIBR-277 Impurity; TAK-536 Impurity
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to ensure traceability and compliance with pharmaceutical impurity standard requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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