Description

Diflunisal Impurity 1 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 studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during Diflunisal API manufacturing and quality control.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Stability Studies: Employed in forced degradation and long-term stability studies of Diflunisal to understand impurity formation pathways.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control (QC) Testing: Acts as a system suitability standard and a quantitation marker in routine QC testing of Diflunisal batches.
• Research & Development: Used in R&D to study the synthesis, properties, and behavior of Diflunisal-related compounds.

Basic Information

Product Name	Diflunisal Impurity 1
CAS No.	705564-12-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2',4'-Difluoro-4-hydroxy-3-biphenylcarboxylic acid impurity; Diflunisal Related Compound; Diflunisal Specified Impurity; [2-Fluoro-4'-(2-hydroxy-4-fluorophenyl)]benzoic acid; Diflunisal Process Impurity; BP/EP Impurity of Diflunisal; Diflunisal Degradant
EINECS	Contact for details

Quality Control

Every batch of Diflunisal Impurity 1 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, identity, and traceability is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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