Description

Azilsartan Impurity 29 is a designated impurity associated with the active pharmaceutical ingredient Azilsartan medoxomil. 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 quality control laboratories and R&D scientists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Azilsartan-based drug products. The accurate identification and quantification of this impurity are essential for meeting stringent regulatory requirements for drug substance and drug product specifications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Azilsartan medoxomil and related drug products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of the active pharmaceutical ingredient (API).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Azilsartan.
• Process Chemistry Research: Used in API manufacturing process optimization to identify, track, and control the formation of this specific impurity.

Basic Information

Product Name	Azilsartan Impurity 29
CAS No.	139482-04-5
Molecular Formula	C25H20N4O5
Molecular Weight	456.45 g/mol
Synonyms	Azilsartan Related Compound 29; 2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic Acid; 1-[[2'-(5-Oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-2-ethoxy-1H-1,3-benzenedicarboxylic Acid; Azilsartan Oxadiazolone Impurity; Azilsartan Medoxomil Impurity 29; TAK-536 Impurity 29; Edarbi Impurity 29
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity 29 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) that include data from multiple orthogonal techniques such as HPLC, NMR, and MS. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH Q3A(R2), Q3B(R2), and relevant pharmacopeial guidelines.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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