Description

Azilsartan Impurity 11 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 in analytical method development and validation to ensure drug purity and safety. It is primarily used by analytical chemists and quality control laboratories in the pharmaceutical industry for the identification, quantification, and control of impurities in Azilsartan drug substances and finished products.

Application

• Primary use as a certified reference standard (CRS) for analytical testing.
• Identification and quantification of related substances in Azilsartan medoxomil API during stability studies and release testing.
• Method development and validation for HPLC and LC-MS impurity profiling in compliance with ICH guidelines.
• Calibration of analytical instruments to ensure accurate impurity detection limits.
• Supporting regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data.
• Used in pharmaceutical quality control (QC) and quality assurance (QA) processes.
• Research into the degradation pathways and stability profile of Azilsartan-based formulations.

Basic Information

Product Name	Azilsartan Impurity 11
CAS No.	91526-16-8
Molecular Formula	C25H20N4O5
Molecular Weight	456.45 g/mol
Synonyms	Azilsartan Related Compound 11; Azilsartan Medoxomil Impurity 11; 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; (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]benzimidazole-7-carboxylate Impurity; TAK-536 Impurity 11
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure high purity and accurate identification in line with ICH Q3A(R2) and Q3B(R2) guidelines for impurities. Comprehensive Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, purity, and assay.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% 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.