| CAS No. | CATO-C4X-210835 |
| Molecular Formula | C10H11N3O4 |
| Molecular Weight | 237.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Baloxavir Impurity 35 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Baloxavir Impurity 35 (CAS CATO-C4X-210835), a pharmacopoeial impurity reference standard (molecular formula C10H11N3O4, MW 237.21 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Baloxavir Impurity 35 (C10H11N3O4) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. 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 237.21 g/mol, it falls into the medium-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 | C10H11N3O4 |
| Molecular Weight | 237.21 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | ≥95% |
| Storage | Store at 2-8°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 |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 3 |