Description

Azilsartan Impurity CAS NO 1821386-21-3 is a high-purity reference standard used in the analytical profiling and quality control of Azilsartan, an important active pharmaceutical ingredient (API) in antihypertensive medications. This compound is critical for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and monitor process-related impurities, ensuring drug safety and regulatory compliance. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Azilsartan medoxomil API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing, optimizing, and validating chromatographic methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Azilsartan API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Facilitates research into the chemical degradation mechanisms of Azilsartan, aiding in the development of more stable formulations.

Basic Information

Product Name	Azilsartan Impurity
CAS No.	1821386-21-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound; Azilsartan Medoxomil Impurity; TAK-536 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 Impurity of Azilsartan; Azilsartan Process Impurity; Azilsartan Degradant; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing purity, assay, and impurity profiles. Our quality commitment aligns with ICH Q3A/B guidelines and supports compliance requirements for cGMP manufacturing.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid prolonged exposure to high humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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