Description

Diflunisal Impurity 2 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 (API) Diflunisal. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of the NSAID drug Diflunisal.
• Analytical Method Development: Used in HPLC, UPLC, and GC method development and validation to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Diflunisal drug products and formulations.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolic profiles related to Diflunisal.
• Quality Assurance/Control (QA/QC): Provides a benchmark for in-house testing protocols to ensure batch-to-batch consistency and purity of the API.

Basic Information

Product Name	Diflunisal Impurity 2
CAS No.	1258635-47-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2',4'-Difluoro-4-hydroxy[1,1'-biphenyl]-3-carboxylic acid Impurity 2; Diflunisal Related Compound 2; Diflunisal Specified Impurity 2; 5-(2,4-Difluorophenyl)-2-hydroxybenzoic acid Impurity; [1,1'-Biphenyl]-3-carboxylic acid, 2',4'-difluoro-4-hydroxy-, impurity
EINECS	Contact for details

Quality Control

Our Diflunisal Impurity 2 is manufactured and handled under strict quality management systems. Each batch 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, identity, and trace analysis is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
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.