| CAS No. | CATO-C4X-184621 |
| Molecular Formula | C10H12FN5O10P2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO supplies Fludarabine Phosphate EP Impurity C Disodium Salt (CAS CATO-C4X-184621), a pharmacopoeial impurity reference standard (molecular formula C10H12FN5O10P2Na, MW 466.17 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Fludarabine Phosphate EP Impurity C Disodium Salt (C10H12FN5O10P2Na) is characterized by a carbohydrate-derived structure, an amide group, a phosphate ester group, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
As a certified reference material (CRM), Fludarabine Phosphate EP Impurity C Disodium Salt 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.
| Molecular Formula | C10H12FN5O10P2 2*Na |
| Molecular Weight | 466.17 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |