Paliperidone Impurity 41 CAS CATO-C4X-172441

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-172441
Molecular FormulaC35H49FN4O4
Molecular Weight608.79 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Paliperidone Impurity 41 CAS CATO-C4X-172441 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 Paliperidone Impurity 41 (CAS CATO-C4X-172441), a pharmacopoeial impurity reference standard (molecular formula C35H49FN4O4, MW 608.79 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Paliperidone Impurity 41 (C35H49FN4O4) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. 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.

Physical & Chemical Properties

Molecular FormulaC35H49FN4O4
Molecular Weight608.79 g/mol
Purity>95%
StorageStore in a cool place (≤25°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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms4

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