Ledipasvir Impurity 56 CAS CATO-C4X-331356
| CAS No. | CATO-C4X-331356 |
| Molecular Formula | C14H7BrF2O2 |
| Molecular Weight | 325.10 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Ledipasvir Impurity 56 (CAS CATO-C4X-331356, C14H7BrF2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Ledipasvir Impurity 56 (C14H7BrF2O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine/bromine substitution, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 325.10 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
As a certified reference material (CRM), Ledipasvir Impurity 56 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 | C14H7BrF2O2 |
| Molecular Weight | 325.10 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Br-containing |
Related Ledipasvir Standards
- Ledipasvir Impurity 46 (CAS CATO-C4X-331346)
- Ledipasvir Impurity 44 (CAS CATO-C4X-331344)
- Ledipasvir Impurity 19 (CAS CATO-C4X-331319)
- Ledipasvir Impurity 41 (CAS CATO-C4X-331341)
- Ledipasvir Impurity 52 (CAS CATO-C4X-331352)
- Ledipasvir Impurity 50 (CAS CATO-C4X-331350)
- Ledipasvir Impurity 21 (CAS CATO-C4X-331321)
- Ledipasvir Impurity 40 (CAS CATO-C4X-331340)
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