Description

Azilsartan Impurity CAS NO 1696392-12-7 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antihypertensive drug Azilsartan medoxomil. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and regulatory affairs.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying process-related impurities in Azilsartan medoxomil active pharmaceutical ingredient (API).
• Analytical Method Development and Validation: Used as a standard to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods.
• Quality Control and Batch Release Testing: Essential for routine QC testing of Azilsartan API and finished dosage forms to ensure compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed to monitor impurity formation and degradation pathways in Azilsartan formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Pharmacopoeial Standards: Can be used to support the establishment of monographs for Azilsartan in pharmacopoeias like USP, EP, or JP.

Basic Information

Product Name	Azilsartan Impurity
CAS No.	1696392-12-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound; Azilsartan Medoxomil Impurity; 2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylic Acid (putative); UNII-Contact for details; 1H-Benzimidazole-7-carboxylic acid, 2-ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-; Azilsartan Oxadiazolone Impurity; Azilsartan Degradant
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines.

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 must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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