Paroxetine Hydrochloride Hemihydrate EP Impurity B CAS 127017-69-0(free base)

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.127017-69-0(free base)
Molecular FormulaC20H23NO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Paroxetine Hydrochloride Hemihydrate EP Impurity B CAS 127017-69-0(free base) chemical structure

Description

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.

CATO supplies Paroxetine Hydrochloride Hemihydrate EP Impurity B (CAS 127017-69-0(free base)), a pharmacopoeial impurity reference standard (molecular formula C20H23NO4HCl, MW 377.86 g/mol) used for the identification and quantification of trace impurities in APIs.

Paroxetine Hydrochloride Hemihydrate EP Impurity B (C20H23NO4HCl) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC20H23NO4 HCl
Molecular Weight377.86 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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