| CAS No. | CATO-C4X-199821 |
| Molecular Formula | C63H111N11O12 |
| Molecular Weight | 1214.62 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a process- or degradation-related impurity, Ciclosporin Impurity 21 (CAS CATO-C4X-199821, C63H111N11O12) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Ciclosporin Impurity 21 (C63H111N11O12) 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
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 | C63H111N11O12 |
| Molecular Weight | 1214.62 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 |