Clofazimine EP Impurity A CAS 102262-55-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.102262-55-5
Molecular FormulaC24H16Cl2N4
Molecular Weight431.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clofazimine EP Impurity A CAS 102262-55-5 chemical structure

Description

Clofazimine EP Impurity A (CAS 102262-55-5) is a certified pharmaceutical impurity reference standard with the molecular formula C24H16Cl2N4 and a molecular weight of 431.32 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution, Clofazimine EP Impurity A is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 431.32 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC24H16Cl2N4
Molecular Weight431.32 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Halogen ContentCl-containing
Nitrogen Atoms4

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