Aceclofenac Ethyl (EsterAceclofenac EP Impurity E) CAS 139272-67-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.139272-67-6
Molecular FormulaC18H17Cl2NO4
Molecular Weight382.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Aceclofenac Ethyl (EsterAceclofenac EP Impurity E) CAS 139272-67-6 chemical structure

Description

The occurrence of Aceclofenac Ethyl (EsterAceclofenac EP Impurity E) is closely related to a flavonoid 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.

As a process- or degradation-related impurity, Aceclofenac Ethyl (EsterAceclofenac EP Impurity E) (CAS 139272-67-6, C18H17Cl2NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Aceclofenac Ethyl (EsterAceclofenac EP Impurity E) (C18H17Cl2NO4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine 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. 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 FormulaC18H17Cl2NO4
Molecular Weight382.24 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 methanol, acetonitrile, DMSO, water (slightly soluble)
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1996
Halogen ContentCl-containing
Nitrogen Atoms1

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