Diclofenac Impurity 21 CAS 105836-68-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.105836-68-8
Molecular FormulaC12H9Cl2N
Molecular Weight238.11 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Diclofenac Impurity 21 CAS 105836-68-8 chemical structure

Description

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.

Diclofenac Impurity 21 (CAS 105836-68-8) is a certified pharmaceutical impurity reference standard with the molecular formula C12H9Cl2N and a molecular weight of 238.11 g/mol.

Based on its molecular formula C12H9Cl2N, Diclofenac Impurity 21 contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 238.11 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.

Physical & Chemical Properties

Molecular FormulaC12H9Cl2N
Molecular Weight238.11 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Halogen ContentCl-containing
Nitrogen Atoms1

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