Cloperastine Impurity 5 HCl CAS CATO-C4X-15955

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-15955
Molecular FormulaC20H25NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cloperastine Impurity 5 HCl CAS CATO-C4X-15955 chemical structure

Description

CATO supplies Cloperastine Impurity 5 HCl (CAS CATO-C4X-15955), a pharmacopoeial impurity reference standard (molecular formula C20H25NOHCl, MW 331.88 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Cloperastine Impurity 5 HCl (C20H25NOHCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC20H25NO HCl
Molecular Weight331.88 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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