Description

Fenfluramine Impurity CAS NO 172953-70-7 is a high-purity reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the development and manufacturing of Fenfluramine and related active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories engaged in method validation, stability studies, and ensuring compliance with stringent pharmacopeial guidelines such as ICH Q3A(R2) and ICH Q3B(R2).

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify specific impurities in Fenfluramine drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure API and drug product batches meet predefined impurity specifications.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product safety.
• Stability Studies: Used to monitor the formation of degradation products in Fenfluramine formulations under various stress conditions.
• Research and Development: Supports synthetic route development and process optimization by helping to track and minimize impurity formation.

Basic Information

Product Name	Fenfluramine Impurity
CAS No.	172953-70-7
Molecular Formula	C12H16F3N
Molecular Weight	231.26 g/mol
Synonyms	Fenfluramine Related Compound; 1-[3-(Trifluoromethyl)phenyl]-2-propylamine; N-Propyl-3-(trifluoromethyl)benzeneethanamine; 3-Trifluoromethylphenethylpropylamine; Fenfluramine EP Impurity; Fenfluramine USP Impurity; Norfenfluramine Impurity
EINECS	Contact for details

Quality Control

Every batch of Fenfluramine Impurity (CAS 172953-70-7) is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is supplied with each shipment to support your regulatory and quality assurance 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). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. 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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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