Description

Benzbromarone Impurity 3 is a high-purity reference standard critical for analytical research and quality control in pharmaceutical development. This compound is essential for the accurate identification, quantification, and monitoring of related substances in benzbromarone active pharmaceutical ingredients (APIs) and finished drug products. It is primarily used by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and fine chemical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments in benzbromarone impurity profiling.
• Method Development and Validation: Used in developing and validating HPLC, UPLC, and GC analytical methods for impurity detection and separation.
• Quality Control (QC) Testing: Employed in routine QC testing of benzbromarone API batches to confirm impurity levels are within specified limits (ICH guidelines).
• Stability Studies: A critical component in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research and Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of benzbromarone.

Basic Information

Product Name	Benzbromarone Impurity 3
CAS No.	79302-23-1
Molecular Formula	C17H12Br2O3
Molecular Weight	424.09 g/mol
Synonyms	2-Ethyl-3-(3,5-dibromo-4-hydroxyphenyl)benzofuran-7-carboxylic Acid; 3,5-Dibromo-4-hydroxyphenyl 2-ethyl-7-benzofurancarboxylate Impurity; Benzbromarone Related Compound C; Benzbromarone EP Impurity C; Benzbromarone USP Related Substance C; 2-Ethyl-3-(3,5-dibromo-4-hydroxybenzoyl)benzofuran-7-carboxylic Acid; (2-Ethyl-7-benzofuranyl)(3,5-dibromo-4-hydroxyphenyl)methanone Impurity
EINECS	Contact for details

Quality Control

Every batch of Benzbromarone Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The compound is light-sensitive (store away from light) and may be hygroscopic (moisture-sensitive). For long-term storage, consider desiccation and storage under inert atmosphere to maintain stability and purity.

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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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