| CAS No. | 2343-22-8 |
| Molecular Formula | C8H8FN |
| Molecular Weight | 137.15 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 Sunitinib Impurity 63.
Sunitinib Impurity 63 (CAS 2343-22-8) is a certified pharmaceutical impurity reference standard with the molecular formula C8H8FN and a molecular weight of 137.15 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution, Sunitinib Impurity 63 is typically off-white to pale yellow liquid. Its solid-state physicochemical attributes — including a molecular weight of 137.15 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
As a certified reference material (CRM), Sunitinib Impurity 63 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | C8H8FN |
| Molecular Weight | 137.15 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |