Fluvastatin EP Impurity E CAS CATO-C4X-16515
| CAS No. | CATO-C4X-16515 |
| Molecular Formula | C24H22FNO3 |
| Molecular Weight | 391.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Fluvastatin EP Impurity E is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Fluvastatin EP Impurity E (CAS CATO-C4X-16515) is a certified pharmaceutical impurity reference standard with the molecular formula C24H22FNO3 and a molecular weight of 391.43 g/mol.
The molecular framework of Fluvastatin EP Impurity E (C24H22FNO3) 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. 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.
As a certified reference material (CRM), Fluvastatin EP Impurity E meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C24H22FNO3 |
| Molecular Weight | 391.43 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 sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Fluvastatin Standards
- Fluvastatin Impurity 10 (CAS 920275-10-1)
- Fluvastatin EP Impurity F (CAS 1207963-21-0)
- Fluvastatin Sodium - Impurity F (CAS 2118370-50-4)
- Fluvastatin Lactone (CAS 94061-83-3)
- Fluvastatin EP Impurity C (CAS 2451176-31-9)
- Fluvastatin EP Impurity D (CAS 1160169-39-0)
- Fluvastatin Sodium - Impurity A (CAS 1025085-49-7)
- Fluvastatin Impurity 16 (CAS 2117644-62-7)
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