Fluoxetine Impurity 51 CAS 56161-72-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.56161-72-9
Molecular FormulaC17H18F3NO
Molecular Weight309.33 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluoxetine Impurity 51 CAS 56161-72-9 chemical structure

Description

CATO supplies Fluoxetine Impurity 51 (CAS 56161-72-9), a pharmacopoeial impurity reference standard (molecular formula C17H18F3NO, MW 309.33 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Fluoxetine Impurity 51 (C17H18F3NO) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 309.33 g/mol, it falls into the moderately-high-molecular-weight range. 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.

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 FormulaC17H18F3NO
Molecular Weight309.33 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, protect from light
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1973
Halogen ContentF-containing
Nitrogen Atoms1

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