Paroxetine Impurity 8 CAS CATO-C4X-10358

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-10358
Molecular FormulaC13H19NO
Molecular Weight205.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Paroxetine Impurity 8 CAS CATO-C4X-10358 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Paroxetine Impurity 8.

CATO supplies Paroxetine Impurity 8 (CAS CATO-C4X-10358), a pharmacopoeial impurity reference standard (molecular formula C13H19NO, MW 205.30 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Paroxetine Impurity 8 is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 205.30 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.

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 FormulaC13H19NO
Molecular Weight205.30 g/mol
Purity97%+
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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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