Atorvastatin Calcium EP Impurity D CAS 873950-19-7
| CAS No. | 873950-19-7 |
| Molecular Formula | C26H24FNO5 |
| Molecular Weight | 449.47 g/mol |
| 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 Atorvastatin Calcium EP Impurity D.
As a process- or degradation-related impurity, Atorvastatin Calcium EP Impurity D (CAS 873950-19-7, C26H24FNO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Atorvastatin Calcium EP Impurity D (C26H24FNO5) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 15.0, corresponding to approximately 15 ring(s) or double-bond equivalent(s). With a molecular weight of 449.47 g/mol, it falls into the moderately-high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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), Atorvastatin Calcium EP Impurity D 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 | C26H24FNO5 |
| Molecular Weight | 449.47 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| 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) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Atorvastatin Standards
- Atorvastatin Impurity 86 (CAS 1046118-44-8)
- Atorvastatin Impurity 99 (CAS CATO-C4X-113299)
- Atorvastatin Impurity 27 (CAS 693793-82-7)
- Atorvastatin EP Impurity D (CAS 148146-51-4)
- Atorvastatin Impurity 77 (CAS 2299304-89-3)
- Atorvastatin Impurity 103 (CAS 1797905-42-0)
- Atorvastatin Oxirane Impurity (CAS 1246818-88-1)
- Atorvastatin Impurity 82 (CAS 125971-96-2)
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