Description

Diflunisal Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Diflunisal. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Diflunisal drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control testing to ensure Diflunisal batches meet pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability testing of Diflunisal formulations.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Diflunisal under various conditions.

Basic Information

Product Name	Diflunisal Impurity 3
CAS No.	1639462-15-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diflunisal Related Compound 3; Diflunisal Specified Impurity 3; 2',4'-Difluoro-4-hydroxy[1,1'-biphenyl]-3-carboxylic acid impurity; 5-(2,4-Difluorophenyl)-2-hydroxybenzoic acid impurity; Diflunisal EP Impurity C; Diflunisal Process Impurity; Biphenyl derivative impurity of Diflunisal
EINECS	Contact for details

Quality Control

Every batch of Diflunisal Impurity 3 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay results, and identification data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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