Fluoxetine Impurity 38 CAS 2538-50-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2538-50-3
Molecular FormulaC10H13NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluoxetine Impurity 38 CAS 2538-50-3 chemical structure

Description

CATO supplies Fluoxetine Impurity 38 (CAS 2538-50-3), a pharmacopoeial impurity reference standard (molecular formula C10H13NOHCl, MW 199.68 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Fluoxetine Impurity 38 (C10H13NOHCl) is characterized by a nitrogen-containing heterocyclic scaffold, 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

As a certified reference material (CRM), Fluoxetine Impurity 38 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.

Physical & Chemical Properties

Molecular FormulaC10H13NO HCl
Molecular Weight199.68 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity97%+
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentCl-containing
Nitrogen Atoms1

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