Description

Azilsartan Impurity 28 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 in analytical method development and validation. It is primarily used by pharmaceutical manufacturers and analytical laboratories to ensure product quality, safety, and regulatory compliance. The precise characterization of this impurity is essential for meeting stringent pharmacopeial requirements for Azilsartan-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Azilsartan Impurity 28 in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC/UPLC methods for Azilsartan API and its formulations.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency according to ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) 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

Item	Details
Product Name	Azilsartan Impurity 28
CAS No.	1514933-24-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound 28; Azilsartan EP Impurity K; 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; 1-[[2'-(4,5-Dihydro-5-oxo-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; Azilsartan Oxadiazole N-Oxide Ester Impurity
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity 28 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity assay and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. Our quality commitment aligns with ICH Q3A/B guidelines and relevant pharmacopeial expectations.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. 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 (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.