Pitavastatin Impurity 15 CAS CATO-C4X-103715
| CAS No. | CATO-C4X-103715 |
| Molecular Formula | C25H22FNO3 |
| Molecular Weight | 403.45 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Pitavastatin Impurity 15 (CAS CATO-C4X-103715, C25H22FNO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Pitavastatin Impurity 15 (C25H22FNO3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
As a certified reference material (CRM), Pitavastatin Impurity 15 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C25H22FNO3 |
| Molecular Weight | 403.45 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Pitavastatin Standards
- Pitavastatin Impurity 4 (CAS 141750-63-2)
- Pitavastatin Impurity 74 (CAS CATO-C4X-103774)
- Pitavastatin Impurity 114 (CAS CATO-C4X-1037114)
- Pitavastatin Impurity 136 (CAS 1611991-87-7)
- Pitavastatin Impurity 111 (CAS CATO-C4X-1037111)
- Pitavastatin Impurity 108 (CAS CATO-C4X-1037108)
- Pitavastatin Impurity 121 (CAS 1809100-36-4)
- Pitavastatin Impurity 88 (CAS 222306-15-2)
Recommended Standards
- Apremilast Impurity 54 (CAS CATO-C4X-100954)
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