Description

Fluorofenidone Impurity CAS NO 1107650-67-8 is a high-purity reference standard critical for analytical research and quality control in pharmaceutical development. This compound serves as a key impurity marker for the active pharmaceutical ingredient Fluorofenidone, enabling precise identification and quantification during method validation and batch release testing. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Fluorofenidone drug substance and finished products.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Stability Studies: Acts as a system suitability standard in routine QC testing and forced degradation studies to monitor impurity levels over time.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and NMPA.
• Process Chemistry Research: Aids in understanding the formation and fate of this impurity during the synthesis and purification of Fluorofenidone.

Basic Information

Product Name	Fluorofenidone Impurity
CAS No.	1107650-67-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fluorofenidone Related Compound; Fluorofenidone Specified Impurity; Fluorofenidone Process Impurity; 1-(3-Fluorophenyl)-5-methyl-2-(1H)-pyridinone Impurity; PFDN Impurity; AKF-PD Impurity; Fluorofenidone Analog
EINECS	Contact for details

Quality Control

Every batch of Fluorofenidone Impurity (CAS 1107650-67-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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