Description

Azilsartan Impurity CAS NO 1863930-34-0 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization, method validation, and quality control of the active pharmaceutical ingredient (API) Azilsartan, an angiotensin II receptor blocker used in antihypertensive medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Azilsartan API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and precision.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical quality control laboratories to monitor impurity levels and ensure product consistency.
• Regulatory Compliance and Submission: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Stability Studies: Used as a marker to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Research and Development (R&D): Facilitates process chemistry research aimed at understanding and minimizing impurity formation during API synthesis.

Basic Information

Product Name	Azilsartan Impurity
CAS No.	1863930-34-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Azilsartan Related Compound; Azilsartan Process 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; Azilsartan Oxadiazolone Impurity; TAK-491 Impurity; Edarbi Impurity
EINECS	Contact for details

Quality Control

Every batch of Azilsartan Impurity (CAS 1863930-34-0) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting regulatory requirements and your quality assurance protocols.

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 must be kept under dry, inert conditions to maintain stability and purity. Ensure the container is sealed immediately after use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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