Description

Fenbufen Impurity 4 (Fenbufen Ep Impurity D) CAS NO 74277-78-4 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Fenbufen. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Fenbufen drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Fenbufen Impurity D in drug substances and products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Fenbufen API and formulations meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., Drug Master Files, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Supports research into the chemical stability and degradation mechanisms of Fenbufen, aiding in formulation optimization.

Basic Information

Product Name	Fenbufen Impurity 4 (Fenbufen Ep Impurity D)
CAS No.	74277-78-4
Molecular Formula	C16H14O3
Molecular Weight	254.28 g/mol
Synonyms	Fenbufen Impurity D; Fenbufen EP Impurity D; Fenbufen Related Compound D; γ-Oxo-[1,1'-biphenyl]-4-butanoic Acid; 4-(4-Biphenylyl)-4-oxobutanoic Acid; Biphenyl-4-yl-γ-oxobutyric Acid; Fenbufen Keto Acid; Fenbufen Impurity 4 (EP)
EINECS	Contact for details

Quality Control

Every batch of Fenbufen Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. 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 at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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