Pitavastatin Impurity 98 CAS CATO-C4X-103798
| CAS No. | CATO-C4X-103798 |
| Molecular Formula | C25H23FNO4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Structurally, Pitavastatin Impurity 98 (C25H23FNO4Na) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 14.5, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 443.45 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
Pitavastatin Impurity 98 (CAS CATO-C4X-103798) is a certified pharmaceutical impurity reference standard with the molecular formula C25H23FNO4Na and a molecular weight of 443.45 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 | C25H23FNO4 Na |
| Molecular Weight | 443.45 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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- [3-Chloro-5-(trifluoromethyl)pyridin-2-yl](hydroxyimino)acetonitrile (CAS 1993661-37-2)
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- Methyl 3-bromo-1H-pyrrolo[2,3-c]pyridine-7-carboxylate (CAS 1403821-67-9)
- Proinsulin C-Peptide (55-89) (human) (CAS 11097-48-6)
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