Description

Azilsartan Impurity O 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 regulatory requirements for drug approval and batch release.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Azilsartan Impurity O in drug substances and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Azilsartan API.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product stability testing.
• Research & Process Chemistry: Aids in understanding the degradation pathways and synthesis by-products of Azilsartan, helping to refine manufacturing processes.

Basic Information

Product Name	Azilsartan Impurity O
CAS No.	2171316-29-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound O; Azilsartan EP Impurity O; Azilsartan USP Impurity O; (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; TA-020 Impurity O; TAK-536 Impurity O; Edarbi Impurity O
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity O is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.