Description

Azilsartan Impurity N is a designated impurity of the antihypertensive active pharmaceutical ingredient (API) Azilsartan. This compound is critical for analytical research and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry for method development, validation, and ensuring the purity and safety of Azilsartan-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Azilsartan Impurity N in drug substances and products.
• Analytical Method Development: Used in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Essential for routine testing in QC laboratories to monitor impurity levels and ensure batch-to-batch consistency of Azilsartan API.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and develop purification processes.

Basic Information

Product Name	Azilsartan Impurity N
CAS No.	2244031-86-3
Molecular Formula	C25H20N4O5
Molecular Weight	456.45 g/mol
Synonyms	Azilsartan Related Compound N; 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 N
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity N is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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