| CAS No. | 1187966-95-5 |
| Molecular Formula | C20H14FN |
| Molecular Weight | 287.33 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 287.33 g/mol gives Pitavastatin Impurity 54 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Pitavastatin Impurity 54 (CAS 1187966-95-5), a pharmacopoeial impurity reference standard (molecular formula C20H14FN, MW 287.33 g/mol) used for the identification and quantification of trace impurities in APIs.
Pitavastatin Impurity 54 (C20H14FN) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C20H14FN |
| Molecular Weight | 287.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1989 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |