Description

Azilsartan Impurity CAS NO 1675221-59-6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antihypertensive drug Azilsartan. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for method development, validation, and routine quality control testing of Azilsartan active pharmaceutical ingredient (API) and finished dosage forms.
• Impurity Profiling and Characterization: Critical for identifying, monitoring, and controlling specified and unspecified impurities during API synthesis and drug product stability studies as per ICH guidelines.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity identification data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Analytical Method Development: Serves as a key component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity separation and analysis.
• Stability Studies: Used to assess the degradation pathways of Azilsartan under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability testing protocols.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway for Azilsartan by identifying and tracking process-related impurities.

Basic Information

Product Name	Azilsartan Impurity
CAS No.	1675221-59-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound; Azilsartan Impurity Standard; Azilsartan Process Impurity; 2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylic acid (related); 1,2,4-Oxadiazole, Azilsartan derivative; TAK-536 Impurity; Edarbi Impurity
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity CAS NO 1675221-59-6 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.