Clotrimazole EP Impurity A CAS 66774-02-5
| CAS No. | 66774-02-5 |
| Molecular Formula | C19H15ClO |
| Molecular Weight | 294.77 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Clotrimazole EP Impurity A is closely related to a steroid core, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Clotrimazole EP Impurity A (CAS 66774-02-5, C19H15ClO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C19H15ClO, Clotrimazole EP Impurity A contains a steroid core, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 294.77 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 Formula | C19H15ClO |
| Molecular Weight | 294.77 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >90% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1976 |
| Halogen Content | Cl-containing |
Related Clotrimazole Standards
- Clotrimazole Impurity 16 (CAS 6922-89-0)
- Clotrimazole Impurity 21 (CAS 29647-82-3)
- Clotrimazole Impurity 1 (CAS 968-39-8)
- Clotrimazole Impurity 17 (CAS 717109-42-7)
- Clotrimazole Impurity 8 (CAS CATO-C4X-15698)
- Clotrimazole EP Impurity F (CAS 15469-97-3)
- Clotrimazole Impurity 27 (CAS 56153-60-7)
- Clotrimazole Impurity 20 (CAS 27023-37-6)
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