Description

Azilsartan Impurity CAS NO 1604812-35-2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Azilsartan, an angiotensin II receptor blocker (ARB) medication. 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 (CRM) for the identification and quantification of impurities in Azilsartan active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, to monitor impurity profiles throughout the drug manufacturing process.
• Stability Studies: Used in forced degradation and long-term stability studies to track the formation and levels of this specific impurity under various stress conditions.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in QC laboratories to ensure drug product specifications are met.
• Process Chemistry Research: Aids in understanding the synthetic pathway of Azilsartan, helping to optimize processes to minimize the formation of this impurity.

Basic Information

Product Name	Azilsartan Impurity
CAS No.	1604812-35-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound; Azilsartan Process Impurity; TAK-491 Impurity; 1-[[2'-(5-Oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-2-ethoxy-1H-benzimidazole-7-carboxylic Acid Impurity; Edarbi Impurity; Azilsartan Medoxomil Impurity; 1604812-35-2
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, 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 for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.