Ciclosporin Impurity 17 CAS CATO-C4X-199817
| CAS No. | CATO-C4X-199817 |
| Molecular Formula | C63H111N11O13 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ciclosporin Impurity 17.
As a process- or degradation-related impurity, Ciclosporin Impurity 17 (CAS CATO-C4X-199817, C63H111N11O13) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Ciclosporin Impurity 17 (C63H111N11O13) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 14.0, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 1230.64 g/mol, it falls into the high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C63H111N11O13 |
| Molecular Weight | 1230.64 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| 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 |
| Degree of Unsaturation (DBE) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 11 |
Related Ciclosporin Standards
- Ciclosporin EP Impurity D (CAS 108027-45-8)
- Ciclosporin EP Impurity F (CAS 437611-17-1)
- Ciclosporin EP Impurity B (CAS 59865-15-5)
- Ciclosporin EP Impurity C (CAS 59865-16-6)
- Ciclosporin EP Impurity G (CAS 63775-96-2)
- Ciclosporin Impurity 11 (CAS CATO-C4X-199811)
- Ciclosporin Impurity 12 (CAS CATO-C4X-199812)
- Ciclosporin Impurity 19 (CAS CATO-C4X-199819)
Recommended Standards
- Elagolix Impurity 33 (CAS CATO-C4X-206833)
- Dapagliflozin Impurity 148 (CAS 342043-51-0)
- Carbocisteine Impurity 36 (CAS CATO-C4X-201036)
- Pam2CSK4 (CAS 868247-72-7)
- 2-Dodecyl-4,4,5,5-tetramethyl-1,3,2-dioxaborolane (CAS 177035-82-4)
- 4-(Difluoromethyl)-2-fluoro-3-iodo-5-methylpyridine (CAS 1805192-65-7)
- 4-Bromo-N,N-dimethyl-1H-indole-3-methanamine (CAS 64258-88-4)
- 2-((Dimethylamino)methylene)-5-(furan-2-yl)cyclohexane-1,3-dione (CAS 1049031-82-4)
- 1-(Amino(4-fluorophenyl)methyl)cyclobutanol (CAS 1402152-75-3)
- Tirzepatide-d7 Ditrifluoroacetate (CAS CATO-CPTD788698)
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