| CAS No. | 31468-19-6 |
| Molecular Formula | C7H16N2O |
| Molecular Weight | 144.22 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 Bosutinib Impurity N9.
Bosutinib Impurity N9 (CAS 31468-19-6) is a certified pharmaceutical impurity reference standard with the molecular formula C7H16N2O and a molecular weight of 144.22 g/mol.
Structurally, Bosutinib Impurity N9 (C7H16N2O) contains an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 1.0, corresponding to approximately 1 ring(s) or double-bond equivalent(s). With a molecular weight of 144.22 g/mol, it falls into the low-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 | C7H16N2O |
| Molecular Weight | 144.22 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 1965 |
| Nitrogen Atoms | 2 |