Diclofenac Sodium Impurity 35 CAS 13625-57-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.13625-57-5
Molecular FormulaC13H9Cl2NO2
Molecular Weight282.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Diclofenac Sodium Impurity 35 CAS 13625-57-5 chemical structure

Description

The occurrence of Diclofenac Sodium Impurity 35 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Diclofenac Sodium Impurity 35 (CAS 13625-57-5) is a certified pharmaceutical impurity reference standard with the molecular formula C13H9Cl2NO2 and a molecular weight of 282.12 g/mol.

Based on its molecular formula C13H9Cl2NO2, Diclofenac Sodium Impurity 35 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 282.12 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

CATO manufactures Diclofenac Sodium Impurity 35 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC13H9Cl2NO2
Molecular Weight282.12 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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; 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.)1960
Halogen ContentCl-containing
Nitrogen Atoms1

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