Description

Olmesartan Ethyl Ester Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of Olmesartan medoxomil, an important angiotensin II receptor blocker (ARB) antihypertensive medication. This high-purity compound is essential for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Olmesartan medoxomil Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods used in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) and audits by providing necessary data for impurity profiles as mandated by ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies & Forced Degradation: Used to monitor impurity levels in stability testing programs and to identify degradation products formed under stress conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Olmesartan medoxomil to minimize the formation of this specific impurity.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to ensure drug substance and drug product purity meets established specifications.

Basic Information

Product Name	Olmesartan Ethyl Ester Impurity
CAS No.	144689-23-6
Molecular Formula	C26H28N2O4
Molecular Weight	432.51 g/mol
Synonyms	Olmesartan Ethyl Ester; 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxylic Acid Ethyl Ester; Benicar Impurity; Olmesartan Medoxomil Impurity; Olmesartan Ethyl Ester Related Compound; UNII-8WY1K8Q2V5; 1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, ethyl ester
EINECS	Contact for details

Quality Control

Our Olmesartan Ethyl Ester Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, 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 every shipment. Our quality commitment aligns with the principles of cGMP and relevant ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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