Description

Azilsartan Impurity 59 is a designated impurity standard used in the pharmaceutical development and quality control of the antihypertensive drug Azilsartan. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential tool for analytical laboratories and quality assurance departments within pharmaceutical manufacturing and research & development organizations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Azilsartan Impurity 59 in active pharmaceutical ingredient (API) and finished drug product batches.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and understand the degradation pathways of Azilsartan.
• Regulatory Compliance and Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control and meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Process Chemistry Research: Aids in the investigation and optimization of synthetic routes by tracking the formation and fate of specific impurities during Azilsartan manufacturing.
• Quality Control (QC) Testing: Acts as a system suitability standard and a calibrant in routine QC testing to ensure batch-to-batch consistency and purity of the Azilsartan API.

Basic Information

Product Name	Azilsartan Impurity 59
CAS No.	1225044-11-0
Molecular Formula	C25H20N4O5
Molecular Weight	456.45 g/mol
Synonyms	Azilsartan Related Compound 59; Azilsartan EP Impurity I; 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; Azilsartan Oxadiazolone Impurity; TAK-536 Impurity 59
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity 59 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical results. Our quality standards are designed to support compliance with ICH guidelines and global pharmacopoeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.2%

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