Description

Azilsartan Impurity 23 is a designated impurity of the antihypertensive active pharmaceutical ingredient (API) Azilsartan. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily used by pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and quality control of Azilsartan-based drug products. The availability of a well-characterized impurity standard is essential for meeting stringent global regulatory requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Azilsartan API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Azilsartan.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of the API.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research & Process Chemistry: Aids in understanding the degradation pathways of Azilsartan and optimizing synthetic processes to minimize impurity formation.

Basic Information

Product Name	Azilsartan Impurity 23
CAS No.	1883681-10-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound 23; Azilsartan EP Impurity J; Azilsartan USP Impurity; 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)-1H-benzimidazole-7-carboxylate; TAK-536 Impurity 23; Edarbi Impurity 23
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity 23 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with ICH Q3A/B guidelines for impurities in new drug substances and products. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. Our quality commitment supports your compliance with USP, EP, and other pharmacopeial standards.

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 should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.