| CAS No. | CATO-C4X-274936 |
| Molecular Formula | C15H6F6N6S |
| Molecular Weight | 416.30 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Apalutamide Impurity 36.
CATO supplies Apalutamide Impurity 36 (CAS CATO-C4X-274936), a pharmacopoeial impurity reference standard (molecular formula C15H6F6N6S, MW 416.30 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Apalutamide Impurity 36 (C15H6F6N6S) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, sulfur-containing functionality, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 416.30 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C15H6F6N6S |
| Molecular Weight | 416.30 g/mol |
| Purity | >95% |
| 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 6 |
| Sulfur Atoms | 1 |