Description

2-Ethoxy-1-[[2'-[1-(Trityl)-1H-Tetrazol-5-Yl][1,1'-Biphenyl]-4-Yl]Methyl]-1H-Benzimidazole-4-Carboxylic Acid Methyl Ester is a key chemical reference standard, specifically identified as a process-related impurity of Candesartan. This high-purity compound is essential for pharmaceutical research and development, enabling accurate method development, validation, and quality control of the active pharmaceutical ingredient (API). It is primarily utilized by analytical laboratories, quality assurance departments, and R&D scientists within the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of this specific impurity in Candesartan Cilexetil API and its formulations.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine quality control testing of Candesartan batches to ensure they meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the manufacturing process.
• Process Chemistry Research: Used to study and optimize the synthetic pathway of Candesartan to minimize the formation of this specific by-product.

Basic Information

Item	Detail
Product Name	2-Ethoxy-1-[[2'-[1-(Trityl)-1H-Tetrazol-5-Yl][1,1'-Biphenyl]-4-Yl]Methyl]-1H-Benzimidazole-4-Carboxylic Acid Methyl Ester (Candesartan Impurity)
CAS No.	150058-29-0
Molecular Formula	C47H38N6O3
Molecular Weight	734.85 g/mol
Synonyms	Candesartan Trityl Tetrazole Impurity; Candesartan Intermediate Trityl Ester; 1-[[2'-(1-Trityl-1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-2-ethoxy-1H-benzimidazole-7-carboxylic Acid Methyl Ester; Methyl 2-Ethoxy-1-[[2'-[1-(triphenylmethyl)-1H-tetrazol-5-yl][1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylate; TCV-116 Trityl Impurity; Candesartan Cilexetil Trityl Tetrazole Intermediate; Candesartan Related Compound C (Trityl); AT1 Receptor Antagonist Impurity.
EINECS	Contact for details

Quality Control

Every batch of this Candesartan impurity standard is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference material. A detailed Certificate of Analysis (COA) is supplied with each shipment, reporting results from identity confirmation (IR, NMR), purity assay (HPLC), and related substance analysis. Our quality protocols are designed to meet the rigorous standards expected in pharmaceutical R&D and QC laboratories.

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); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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