Fenfluramine Impurity 1 CAS 52777-74-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.52777-74-9
Molecular FormulaC13H18F3N
Molecular Weight245.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fenfluramine Impurity 1 CAS 52777-74-9 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Fenfluramine Impurity 1.

Fenfluramine Impurity 1 (CAS 52777-74-9) is a certified pharmaceutical impurity reference standard with the molecular formula C13H18F3N and a molecular weight of 245.28 g/mol.

Structurally, Fenfluramine Impurity 1 (C13H18F3N) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 245.28 g/mol, it falls into the medium-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC13H18F3N
Molecular Weight245.28 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972
Halogen ContentF-containing
Nitrogen Atoms1

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