Description

Azilsartan Impurity A is a specified impurity and a key chemical reference standard used in the quality control of the active pharmaceutical ingredient (API) Azilsartan. This compound is critical for ensuring the purity, safety, and efficacy of cardiovascular medications containing Azilsartan medoxomil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Azilsartan API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Assurance & Control (QA/QC): Serves as a system suitability standard and for routine batch release testing in GMP environments.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and in pharmacokinetic studies.

Basic Information

Product Name	Azilsartan Impurity A
CAS No.	147404-76-0
Molecular Formula	C25H20N4O5
Molecular Weight	456.45 g/mol
Synonyms	2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylic Acid; Azilsartan Related Compound A; TAK-536 Impurity A; (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)biphenyl-4-yl]methyl]benzimidazole-7-carboxylate Impurity; BMS-635052 Impurity A
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity A is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results and traceability is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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