Aceclofenac Impurity 12 CAS CATO-C4X-153112

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-153112
Molecular FormulaC18H19Cl2NO3
Molecular Weight368.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Aceclofenac Impurity 12 CAS CATO-C4X-153112 chemical structure

Description

As a certified reference material (CRM), Aceclofenac Impurity 12 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.

CATO supplies Aceclofenac Impurity 12 (CAS CATO-C4X-153112), a pharmacopoeial impurity reference standard (molecular formula C18H19Cl2NO3, MW 368.25 g/mol) used for the identification and quantification of trace impurities in APIs.

Aceclofenac Impurity 12 (C18H19Cl2NO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

Physical & Chemical Properties

Molecular FormulaC18H19Cl2NO3
Molecular Weight368.25 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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