| CAS No. | CATO-C4X-106469 |
| Molecular Formula | C36H27B3O6 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
CATO supplies Ibrutinib Impurity 69 (CAS CATO-C4X-106469), a pharmacopoeial impurity reference standard (molecular formula C36H27B3O6C12H11BO3, MW 802.06 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Ibrutinib Impurity 69 (C36H27B3O6C12H11BO3) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 30.0, corresponding to approximately 30 ring(s) or double-bond equivalent(s). With a molecular weight of 802.06 g/mol, it falls into the 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.
| Molecular Formula | C36H27B3O6 C12H11BO3 |
| Molecular Weight | 802.06 g/mol |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 30.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |