Fluoxetine Impurity 35 CAS 21970-65-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.21970-65-0
Molecular FormulaC17H19NO
Molecular Weight253.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fluoxetine Impurity 35 CAS 21970-65-0 chemical structure

Description

CATO supplies Fluoxetine Impurity 35 (CAS 21970-65-0), a pharmacopoeial impurity reference standard (molecular formula C17H19NO, MW 253.34 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Fluoxetine Impurity 35 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 253.34 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 35 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 FormulaC17H19NO
Molecular Weight253.34 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1963
Nitrogen Atoms1

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