Asenapine Impurity 11 CAS CATO-C4X-194711

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-194711
Molecular FormulaC17H14ClNO
Molecular Weight283.75 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Asenapine Impurity 11 CAS CATO-C4X-194711 chemical structure

Description

The molecular framework of Asenapine Impurity 11 (C17H14ClNO) 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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a process- or degradation-related impurity, Asenapine Impurity 11 (CAS CATO-C4X-194711, C17H14ClNO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 FormulaC17H14ClNO
Molecular Weight283.75 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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