| CAS No. | CATO-C4X-19173 |
| Molecular Formula | C41H65F5O4S2 |
| Molecular Weight | 781.07 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 781.07 g/mol gives Fulvestrant EP Impurity C distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Fulvestrant EP Impurity C (CAS CATO-C4X-19173), a pharmacopoeial impurity reference standard (molecular formula C41H65F5O4S2, MW 781.07 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Fulvestrant EP Impurity C (C41H65F5O4S2) contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 781.07 g/mol, it falls into the high-molecular-weight range. 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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
| Molecular Formula | C41H65F5O4S2 |
| Molecular Weight | 781.07 g/mol |
| Purity | >95% |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Sulfur Atoms | 2 |