Fluvastatin EP Impurity A (Calcium Salt) CAS CATO-C4X-16518
| CAS No. | CATO-C4X-16518 |
| Molecular Formula | 4*C24H25FNO4 |
| 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 Fluvastatin EP Impurity A (Calcium Salt).
As a process- or degradation-related impurity, Fluvastatin EP Impurity A (Calcium Salt) (CAS CATO-C4X-16518, C24H25FNO4Ca) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Fluvastatin EP Impurity A (Calcium Salt) (C24H25FNO4Ca) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 12.5, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 450.54 g/mol, it falls into the moderately-high-molecular-weight range. 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 A (Calcium Salt) 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 | 4*C24H25FNO4 2*Ca |
| Molecular Weight | 450.54 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) | 12.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Fluvastatin Standards
- Fluvastatin EP Impurity G (CAS 101125-34-2)
- Fluvastatin Impurity 20 (CAS 1025064-18-9)
- Fluvastatin Sodium - Impurity A (CAS 1025085-49-7)
- Fluvastatin EP Impurity D (CAS 1160169-39-0)
- Fluvastatin EP Impurity F (CAS 1207963-21-0)
- Fluvastatin-d7 Sodium Salt (CAS 1260178-87-7)
- Fluvastatin USP RC B (CAS 129332-29-2)
- Fluvastatin Impurity 11 (CAS 1331643-17-4)
Recommended Standards
- Cholic Acid Impurity 4 (CAS CATO-C4X-11604)
- Triamcinolone Acetonide Impurity N2 (CAS 1893-84-1)
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- 2-Hydroxyhexahydro-1H-isoindole-1,3(2H)-dione (CAS 18886-85-6)
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- (S)-2-(1-Hydroxyethyl)benzaldehyde (CAS 157563-46-7)
- 2-(6-Amino-8-bromo-9H-purin-9-yl)ethyl acetate (CAS 874903-79-4)
- 4-Bromo-3,3-dimethylindoline (CAS 1227418-26-9)
- (4-(5-(Difluoromethyl)pyridin-2-yl)-1-methyl-1H-1,2,3-triazol-5-yl)methanol (CAS 2760882-48-0)
- Insulin B (22-25) (CAS 34367-73-2)
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