Description

Eprosartan Related Compound A is a high-purity reference standard and pharmaceutical intermediate of significant analytical importance. Its primary value lies in its critical role in the quality control and regulatory compliance of Eprosartan mesylate, an active pharmaceutical ingredient (API) used in antihypertensive medications. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and ensuring batch-to-batch consistency of the final drug product.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Eprosartan mesylate API and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels and ensure API purity meets stringent pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Eprosartan formulations to understand degradation pathways.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Utilized in synthetic chemistry R&D for process optimization and the development of new synthetic routes for angiotensin II receptor antagonists.

Basic Information

Product Name	Eprosartan Related Compound A
CAS No.	1169702-90-2
Molecular Formula	C23H24N2O4S
Molecular Weight	424.51 g/mol
Synonyms	Eprosartan Impurity A; (E)-2-Butyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1H-imidazole-5-acrylic Acid; Eprosartan EP Impurity A; Eprosartan USP Related Compound A; Eprosartan Acid Impurity; Teveten Impurity A; SK&F 108566 Related Compound A
EINECS	Contact for details

Quality Control

Our Eprosartan Related Compound A 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. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards. Our quality commitment aligns with ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	98.0% - 102.0%

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