Pitavastatin Impurity 78 CAS CATO-C4X-103778
| CAS No. | CATO-C4X-103778 |
| Molecular Formula | C22H18FNO |
| Molecular Weight | 331.38 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Pitavastatin Impurity 78 (C22H18FNO) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, 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. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
Pitavastatin Impurity 78 (CAS CATO-C4X-103778) is a certified pharmaceutical impurity reference standard with the molecular formula C22H18FNO and a molecular weight of 331.38 g/mol.
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.
Physical & Chemical Properties
| Molecular Formula | C22H18FNO |
| Molecular Weight | 331.38 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Pitavastatin Standards
- Pitavastatin Impurity 18 (CAS 148516-11-4)
- Pitavastatin Impurity 41 (CAS CATO-C4X-103741)
- Pitavastatin Impurity 40 (CAS 121659-86-7)
- Pitavastatin Impurity 85 (CAS CATO-C4X-103785)
- Pitavastatin Impurity 21 (CAS 154057-56-4)
- Pitavastatin Impurity 42 (CAS CATO-C4X-103742)
- Pitavastatin Impurity 43 (CAS CATO-C4X-103743)
- Pitavastatin Hydroxymethyl Impurity (CAS 24922-02-9)
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