Ciclosporin EP Impurity B CAS 59865-15-5
| CAS No. | 59865-15-5 |
| Molecular Formula | C62H113N11O12 |
| Molecular Weight | 1204.63 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
CATO supplies Ciclosporin EP Impurity B (CAS 59865-15-5), a pharmacopoeial impurity reference standard (molecular formula C62H113N11O12, MW 1204.63 g/mol) used for the identification and quantification of trace impurities in APIs.
Ciclosporin EP Impurity B (C62H113N11O12) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
Physical & Chemical Properties
| Molecular Formula | C62H113N11O12 |
| Molecular Weight | 1204.63 g/mol |
| Purity | >95% |
| 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1974 |
| Nitrogen Atoms | 11 |
Related Ciclosporin Standards
- Ciclosporin EP Impurity C (CAS 59865-16-6)
- Ciclosporin Impurity 12 (CAS CATO-C4X-199812)
- Ciclosporin Impurity 23 (CAS CATO-C4X-199823)
- Ciclosporin Impurity 19 (CAS CATO-C4X-199819)
- Ciclosporin Impurity 20 (CAS CATO-C4X-199820)
- Ciclosporin Impurity 11 (CAS CATO-C4X-199811)
- Ciclosporin Impurity 21 (CAS CATO-C4X-199821)
- Ciclosporin EP Impurity G (CAS 63775-96-2)
Recommended Standards
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Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com