Fluoxetine Impurity 18 CAS 60577-28-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.60577-28-8
Molecular FormulaC11H17NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluoxetine Impurity 18 CAS 60577-28-8 chemical structure

Description

As a certified reference material (CRM), Fluoxetine Impurity 18 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Fluoxetine Impurity 18 (CAS 60577-28-8) is a certified pharmaceutical impurity reference standard with the molecular formula C11H17NOHCl and a molecular weight of 215.72 g/mol.

The molecular framework of Fluoxetine Impurity 18 (C11H17NOHCl) is characterized by an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

Physical & Chemical Properties

Molecular FormulaC11H17NO HCl
Molecular Weight215.72 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1974
Halogen ContentCl-containing
Nitrogen Atoms1

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