| CAS No. | 102262-55-5 |
| Molecular Formula | C24H16Cl2N4 |
| Molecular Weight | 431.32 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
| Molecular Formula | C24H16Cl2N4 |
| Molecular Weight | 431.32 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 18.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1986 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 4 |