| CAS No. | 745767-97-9 |
| Molecular Formula | C18H31NO2 |
| Molecular Weight | 293.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 293.44 g/mol gives Fingolimod EP Impurity B (Fingolimod Heptyl Impurity) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Fingolimod EP Impurity B (Fingolimod Heptyl Impurity) (CAS 745767-97-9) is a certified pharmaceutical impurity reference standard with the molecular formula C18H31NO2 and a molecular weight of 293.44 g/mol.
Based on its molecular formula C18H31NO2, Fingolimod EP Impurity B (Fingolimod Heptyl Impurity) contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 293.44 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C18H31NO2 |
| Molecular Weight | 293.44 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1986 |
| Nitrogen Atoms | 1 |