| CAS No. | CATO-C4X-331354 |
| Molecular Formula | C35H32F2N6 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Ledipasvir Impurity 54 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.
CATO supplies Ledipasvir Impurity 54 (CAS CATO-C4X-331354), a pharmacopoeial impurity reference standard (molecular formula C35H32F2N6HCl, MW 611.14 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine/chlorine substitution, Ledipasvir Impurity 54 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 611.14 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
| Molecular Formula | C35H32F2N6 4*HCl |
| Molecular Weight | 611.14 g/mol |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 21.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 6 |