Fluoxetine Impurity 46 HCL CAS 138614-32-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.138614-32-1
Molecular FormulaC16H16F3NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluoxetine Impurity 46 HCL CAS 138614-32-1 chemical structure

Description

As a certified reference material (CRM), Fluoxetine Impurity 46 HCL 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.

CATO supplies Fluoxetine Impurity 46 HCL (CAS 138614-32-1), a pharmacopoeial impurity reference standard (molecular formula C16H16F3NOHCl, MW 331.76 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Fluoxetine Impurity 46 HCL (C16H16F3NOHCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 331.76 g/mol, it falls into the moderately-high-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.

Physical & Chemical Properties

Molecular FormulaC16H16F3NO HCl
Molecular Weight331.76 g/mol
AppearanceOff-white to pale 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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1996
Halogen ContentF/Cl-containing
Nitrogen Atoms1

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