Description

Eprosartan Impurity 3 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Eprosartan. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of antihypertensive medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Eprosartan mesylate API batches.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): A key component in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Eprosartan formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and impurity profiling during the API development process.

Basic Information

Product Name	Eprosartan Impurity 3
CAS No.	149543-86-2
Molecular Formula	C23H24N2O4S
Molecular Weight	424.51 g/mol
Synonyms	Eprosartan Related Compound C; (E)-2-Butyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-acrylic Acid; 2-Butyl-1-[(2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl)methyl]-1H-imidazole-5-acrylic Acid; Eprosartan Impurity C; Eprosartan EP Impurity C; Eprosartan USP Related Compound C
EINECS	Contact for details

Quality Control

Every batch of Eprosartan Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept sealed to prevent moisture absorption.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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