Description

Azilsartan Impurity 16 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, validation, and quality control. It is primarily required by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Azilsartan-based drug products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Azilsartan API and finished dosage forms.
• Essential for analytical method development and validation (HPLC/LC-MS) in compliance with ICH Q2(R1) guidelines.
• Critical component in stability studies to monitor impurity profiles and establish shelf-life specifications.
• Used in pharmaceutical research to understand degradation pathways and synthesis by-products.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Employed in quality control laboratories for routine batch release testing of Azilsartan.

Basic Information

Product Name	Azilsartan Impurity 16
CAS No.	1417576-00-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound 16; Azilsartan 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 Ester Impurity; TAK-536 Impurity 16
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity 16 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity. 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 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%
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.