Clofazimine Impurity 5 CAS 23008-56-2
| CAS No. | 23008-56-2 |
| Molecular Formula | C12H9ClN2O2 |
| Molecular Weight | 248.67 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Clofazimine Impurity 5 (CAS 23008-56-2, C12H9ClN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Clofazimine Impurity 5 (C12H9ClN2O2) 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 248.67 g/mol, it falls into the medium-molecular-weight range. 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.
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 Formula | C12H9ClN2O2 |
| Molecular Weight | 248.67 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Clofazimine Standards
- Clofazimine Impurity 10 (CAS CATO-C4X-207110)
- Clofazimine Impurity 11 (CAS 74002-27-0)
- Clofazimine Impurity 19 (CAS CATO-C4X-207119)
- Clofazimine Impurity 15 (CAS CATO-C4X-207115)
- Clofazimine Impurity 16 (CAS CATO-C4X-207116)
- Clofazimine Impurity 18 (CAS CATO-C4X-207118)
- Clofazimine Impurity 13 (CAS CATO-C4X-207113)
- Clofazimine Impurity 6 (CAS CATO-C4X-20716)
Recommended Standards
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- 3-(2,3-Dihydrobenzo[b][1,4]dioxin-6-yl)-1-(p-tolyl)-1H-pyrazole-4-carbaldehyde (CAS 618098-94-5)
- n-Hexyl-1,1-d2 Alcohol (CAS 52598-04-6)
- 3-Tert-butyl-1,2,4-oxadiazol-5-ol (CAS 163619-95-2)
- 5,6-dichloro-1,2-benzoxazol-3-ol (CAS 855996-73-5)
- Semaglutide238 (CAS CATO-C4X-2226238)
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