Description

Fenfluramine Impurity CAS NO 21235-67-6 is a high-purity reference standard critical for analytical and regulatory compliance in pharmaceutical development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in active pharmaceutical ingredients (APIs). It is primarily required by quality control laboratories, research institutions, and manufacturers involved in the synthesis and analysis of Fenfluramine and related pharmaceutical compounds to ensure product safety and meet stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Fenfluramine API.
• Analytical Research: Used in HPLC, GC-MS, and LC-MS studies for the identification and characterization of degradation products and synthetic by-products.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed as a marker to monitor impurity formation under various stress conditions (heat, light, humidity) during drug product shelf-life studies.
• Process Chemistry Optimization: Used by R&D and manufacturing teams to identify sources of impurities and refine synthesis pathways for higher purity yields.
• Pharmacopeial Testing: Applied in testing to comply with monographs from USP, EP, and other international pharmacopeias that specify impurity limits.

Basic Information

Product Name	Fenfluramine Impurity
CAS No.	21235-67-6
Molecular Formula	C12H16F3N
Molecular Weight	231.26 g/mol
Synonyms	N-Ethyl-α-methyl-3-(trifluoromethyl)phenethylamine; 1-[3-(Trifluoromethyl)phenyl]-2-(ethylamino)propane; Norfenfluramine; Fenfluramine Related Compound; 3-Trifluoromethyl-N-ethylamphetamine; DL-Norfenfluramine; N-Ethyl-3-trifluoromethylamphetamine
EINECS	Contact for details

Quality Control

Every batch of Fenfluramine Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.