Description

Azilsartan Impurity 58 is a designated impurity of the antihypertensive active pharmaceutical ingredient (API) Azilsartan. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of Azilsartan-based drug products. This high-purity standard is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in API synthesis and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Azilsartan API and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling and stability studies.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Helps in identifying and tracking degradation products formed under various stress conditions.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Azilsartan to minimize the formation of this specific impurity.

Basic Information

Product Name	Azilsartan Impurity 58
CAS No.	209551-67-7
Molecular Formula	C25H20N4O5
Molecular Weight	456.45 g/mol
Synonyms	Azilsartan Related Compound 58; Azilsartan EP Impurity D; Azilsartan USP Impurity; 2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylic Acid; 1-[[2'-(5-Oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-2-ethoxy-1H-benzimidazole-7-carboxylic Acid; TAK-536 Impurity 58; Edarbi Impurity 58
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity 58 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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