| CAS No. | CATO-C4X-105263 |
| Molecular Formula | C16H18FN2O8P |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Sofosbuvir Impurity 63 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 Sofosbuvir Impurity 63 (CAS CATO-C4X-105263), a pharmacopoeial impurity reference standard (molecular formula C16H18FN2O8P·1/6(C7H15NO), MW 545.50 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine substitution, Sofosbuvir Impurity 63 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 545.50 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 | C16H18FN2O8P · 1/6 (C7H15NO) |
| Molecular Weight | 545.50 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 8.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |