Pitavastatin Formyl Impurity CAS 121660-37-5
| CAS No. | 121660-37-5 |
| Molecular Formula | C19H14FNO |
| Molecular Weight | 291.32 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 291.32 g/mol gives Pitavastatin Formyl Impurity distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Pitavastatin Formyl Impurity (CAS 121660-37-5, C19H14FNO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Pitavastatin Formyl Impurity (C19H14FNO) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C19H14FNO |
| Molecular Weight | 291.32 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, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Pitavastatin Standards
- Pitavastatin Impurity 25 (CAS CATO-C4X-103725)
- Pitavastatin Impurity 91 (CAS CATO-C4X-103791)
- Pitavastatin Impurity 55 (CAS 1187966-94-4)
- Pitavastatin Hydroxymethyl Impurity (CAS 24922-02-9)
- Pitavastatin Impurity 81 (CAS CATO-C4X-103781)
- Pitavastatin Impurity 96 (CAS 121660-11-5)
- Pitavastatin Impurity 54 (CAS 1187966-95-5)
- Pitavastatin Impurity 97 (CAS 1356998-79-2)
Recommended Standards
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- 3-((4-Methoxybenzyl)oxy)-3-oxo-2-(4-((tetrahydro-2H-pyran-2-yl)oxy)phenyl)propanoic acid (CAS 70653-29-1)
- 3-(2H-1,2,3-Triazol-2-yl)pyridine (CAS 342616-14-2)
- 1-Cyanoethane-1-sulfonamide (CAS 1248038-60-9)
- (2,4-Dichlorophenyl)(4,5-dimethoxy-2-nitrophenyl)methanone (CAS 374086-20-1)
- Peptide 439 (CAS CATO-CPTD788439)
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