Pitavastatin Impurity 113 CAS CATO-C4X-1037113
| CAS No. | CATO-C4X-1037113 |
| Molecular Formula | 2*C25H23FNO4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pitavastatin Impurity 113.
As a process- or degradation-related impurity, Pitavastatin Impurity 113 (CAS CATO-C4X-1037113, C25H23FNO4Ca) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C25H23FNO4Ca, Pitavastatin Impurity 113 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 460.54 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
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 | 2*C25H23FNO4 Ca |
| Molecular Weight | 460.54 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 14.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Pitavastatin Standards
- Pitavastatin Impurity 92 (CAS 1159588-21-2)
- Pitavastatin Impurity 112 (CAS 1187966-91-1)
- Pitavastatin Impurity 90 (CAS 1187966-91-1（free base）)
- Pitavastatin Impurity 51 (CAS 1187966-93-3)
- Pitavastatin Impurity 55 (CAS 1187966-94-4)
- Pitavastatin Impurity 54 (CAS 1187966-95-5)
- Pitavastatin Impurity 40 (CAS 121659-86-7)
- Pitavastatin Impurity 96 (CAS 121660-11-5)
Recommended Standards
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- N-[4-(aminomethyl)phenyl]-4-(2-methylphenoxy)butanamide (CAS 954563-16-7)
- Vancomycin Hexapeptide (CAS 115236-65-2)
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