N-Nitroso Fluoxetine EP Impurity A CAS 2659259-65-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2659259-65-9
Molecular FormulaC10H14N2O2
Molecular Weight194.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Fluoxetine EP Impurity A CAS 2659259-65-9 chemical structure

Description

The occurrence of N-Nitroso Fluoxetine EP Impurity A is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

N-Nitroso Fluoxetine EP Impurity A (CAS 2659259-65-9) is a certified pharmaceutical impurity reference standard with the molecular formula C10H14N2O2 and a molecular weight of 194.23 g/mol.

N-Nitroso Fluoxetine EP Impurity A (C10H14N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

CATO manufactures N-Nitroso Fluoxetine EP Impurity A under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC10H14N2O2
Molecular Weight194.23 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2002
Nitrogen Atoms2

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