Description

Azilsartan Impurity I is a designated process-related impurity and degradation product of the antihypertensive active pharmaceutical ingredient (API) Azilsartan. This compound is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories and API manufacturers for method validation, stability studies, and establishing impurity profiles to meet stringent regulatory requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Azilsartan medoxomil and related drug substances.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor and control impurity levels during API synthesis.
• Stability Indicating Studies: Employed in forced degradation studies to identify and quantify degradation pathways of Azilsartan under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Serves as a system suitability component and an impurity marker in the routine QC testing of Azilsartan API to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data on impurity identification, qualification, and reporting for drug master files (DMFs), ANDAs, and other regulatory filings to agencies like the FDA and EMA.
• Process Chemistry Research: Used to study and optimize synthetic routes to minimize the formation of this specific impurity, improving overall process yield and purity.

Basic Information

Product Name	Azilsartan Impurity I
CAS No.	139481-33-7
Molecular Formula	C25H20N4O5
Molecular Weight	456.45 g/mol
Synonyms	Azilsartan Related Compound I; (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-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-2-ethoxy-1H-benzimidazol-5-yl)carbonyloxymethyl 5-methyl-2-oxo-1,3-dioxole; TAK-536 Impurity I
EINECS	Contact for details

Quality Control

Our Azilsartan Impurity I is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Quality is assured through comprehensive characterization using techniques like HPLC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each batch, confirming identity, purity, and compliance with in-house specifications aligned with ICH guidelines. Our quality system supports cGMP requirements for pharmaceutical impurity standards.

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 compound 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.