Diclofenac Ethyl Ester (Aceclofenac EP Impurity C) CAS 15307-77-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.15307-77-4
Molecular FormulaC16H15Cl2NO2
Molecular Weight324.20 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Diclofenac Ethyl Ester (Aceclofenac EP Impurity C) CAS 15307-77-4 chemical structure

Description

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.

Diclofenac Ethyl Ester (Aceclofenac EP Impurity C) (CAS 15307-77-4) is a certified pharmaceutical impurity reference standard with the molecular formula C16H15Cl2NO2 and a molecular weight of 324.20 g/mol.

Structurally, Diclofenac Ethyl Ester (Aceclofenac EP Impurity C) (C16H15Cl2NO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 324.20 g/mol, it falls into the moderately-high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

As a certified reference material (CRM), Diclofenac Ethyl Ester (Aceclofenac EP Impurity C) 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 FormulaC16H15Cl2NO2
Molecular Weight324.20 g/mol
AppearancePale yellow to 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1961
Halogen ContentCl-containing
Nitrogen Atoms1

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