Prucalopride Impurity 4 CAS CATO-C4X-10384

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-10384
Molecular FormulaC20H29N3O4
Molecular Weight375.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Prucalopride Impurity 4 CAS CATO-C4X-10384 chemical structure

Description

Prucalopride Impurity 4 (CAS CATO-C4X-10384) is a certified pharmaceutical impurity reference standard with the molecular formula C20H29N3O4 and a molecular weight of 375.46 g/mol.

The molecular framework of Prucalopride Impurity 4 (C20H29N3O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, 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.

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 FormulaC20H29N3O4
Molecular Weight375.46 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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