Brexpiprazole Impurity 21 CAS 2059954-32-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2059954-32-2
Molecular FormulaC17H21Cl2NO2
Molecular Weight342.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Brexpiprazole Impurity 21 CAS 2059954-32-2 chemical structure

Description

The occurrence of Brexpiprazole Impurity 21 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Brexpiprazole Impurity 21 (CAS 2059954-32-2) is a certified pharmaceutical impurity reference standard with the molecular formula C17H21Cl2NO2 and a molecular weight of 342.26 g/mol.

The molecular framework of Brexpiprazole Impurity 21 (C17H21Cl2NO2) 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.

As a certified reference material (CRM), Brexpiprazole Impurity 21 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC17H21Cl2NO2
Molecular Weight342.26 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Halogen ContentCl-containing
Nitrogen Atoms1

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