Description

Olmesartan Dimer Ester Impurity is a high-purity reference standard used in the analytical profiling and quality control of Olmesartan medoxomil, a widely prescribed antihypertensive drug. This compound is critical for ensuring the safety and efficacy of the final pharmaceutical product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on API manufacturing and drug development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development, validation, and routine impurity testing in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Method Development: Crucial for developing and optimizing HPLC, UPLC, and LC-MS methods to separate and quantify this specific dimer ester impurity from Olmesartan medoxomil and other related substances.
• Quality Control & Batch Release: Used in the quality control laboratories of API manufacturers and finished dosage form producers to establish impurity profiles and ensure batch-to-batch consistency.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification in drug master files (DMFs) and common technical documents (CTDs).
• Stability Studies: Employed to monitor the formation and level of this impurity over time under various stress conditions (e.g., heat, humidity, light) as part of forced degradation and shelf-life studies.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Olmesartan medoxomil to minimize the formation of this dimer ester byproduct.

Basic Information

Item	Detail
Product Name	Olmesartan Dimer Ester Impurity
CAS No.	1040250-19-8
Molecular Formula	C48H50N6O10
Molecular Weight	870.95 g/mol
Synonyms	Olmesartan Impurity Dimer Ester; Olmesartan Dimer Ester; Olmesartan Medoxomil Dimer Ester; Olmesartan Related Compound Dimer Ester; 5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1H-imidazole-5-carboxylate dimer ester; Benzimidazole dimer ester impurity of Olmesartan; Olmesartan process impurity Dimer Ester
EINECS	Contact for details

Quality Control

Every batch of Olmesartan Dimer Ester Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with the high-purity standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with each shipment.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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