Description

Azilsartan Impurity 25 is a designated impurity of the antihypertensive active pharmaceutical ingredient (API) Azilsartan. This compound is of critical importance for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory affairs professionals to ensure the purity, safety, and efficacy of Azilsartan-based drug products.

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 in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure product specifications are met.
• 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 (heat, light, humidity) as part of forced degradation studies.
• Process Chemistry Research: Aids in understanding and optimizing the Azilsartan synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Azilsartan Impurity 25
CAS No.	1584730-02-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound 25; Azilsartan Impurity K; 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; 1-[[2'-(5-Oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-2-ethoxy-1H-benzimidazole-7-carboxylic Acid (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester; TAK-536 Impurity 25; Edarbi Impurity 25
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity 25 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance profiling, and structural confirmation (e.g., by NMR, MS). A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data, chromatograms, and traceability information. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.