| CAS No. | 79309-68-5 |
| Molecular Formula | C12H25BO2Si |
| Molecular Weight | 240.22 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Cyclosporin Impurity 16 (CAS 79309-68-5) is a certified pharmaceutical impurity reference standard with the molecular formula C12H25BO2Si and a molecular weight of 240.22 g/mol.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, Cyclosporin Impurity 16 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 240.22 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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.
| Molecular Formula | C12H25BO2Si |
| Molecular Weight | 240.22 g/mol |
| Purity | 97%+ |
| Storage | Store at room temperature |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | Stable under recommended storage conditions |
| Degree of Unsaturation (DBE) | 0.5 |
| CAS Registry Year (est.) | 1979 |