Description

Eprosartan Related Compound C is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker and analytical standard in the quality control of Eprosartan, an angiotensin II receptor antagonist used to treat hypertension. It is essential for laboratories and manufacturers requiring precise analytical validation to ensure drug safety, efficacy, and regulatory compliance. This product is indispensable for pharmaceutical analysis, method development, and stability testing programs.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Eprosartan active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure product consistency meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Eprosartan under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Contract Research and Manufacturing (CRO/CMO): Supports analytical services for clients in the pharmaceutical supply chain requiring impurity identification and control.

Basic Information

Product Name	Eprosartan Related Compound C
CAS No.	4475-24-5
Molecular Formula	C23H24N2O4S
Molecular Weight	424.52 g/mol
Synonyms	Eprosartan Impurity C; Eprosartan EP Impurity C; Eprosartan Related Substance C; (E)-2-Butyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1H-imidazole-5-acrylic acid; 2-Butyl-α-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-acrylic acid; SK&F 108566 Related Compound C
EINECS	Contact for details

Quality Control

Our Eprosartan Related Compound C is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for identity, assay, and impurity profile. Our quality commitment aligns with the needs of cGMP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent absorption of moisture.

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%
Residue on Ignition	≤ 0.2%

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