Atorvastatin Calcium EP Impurity P CAS 581772-29-4
| CAS No. | 581772-29-4 |
| Molecular Formula | C36H39FN2O5 |
| Molecular Weight | 598.70 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Atorvastatin Calcium EP Impurity P is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Atorvastatin Calcium EP Impurity P (CAS 581772-29-4) is a certified pharmaceutical impurity reference standard with the molecular formula C36H39FN2O5 and a molecular weight of 598.70 g/mol.
The molecular framework of Atorvastatin Calcium EP Impurity P (C36H39FN2O5) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 P 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 | C36H39FN2O5 |
| Molecular Weight | 598.70 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 18.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1984 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Atorvastatin Standards
- Atorvastatin Allyl Ester (CAS 915092-85-2)
- Atorvastatin Impurity 33(3S,5R) (CAS CATO-C4X-113233)
- Atorvastatin Impurity 72 (CAS CATO-C4X-113272)
- Atorvastatin Impurity 22 (CAS 1035205-25-4)
- Atorvastatin Cyclic (Fluorophenyl) Impurity (CAS 873950-18-6)
- Atorvastatin Impurity 110 (CAS 887470-43-1)
- Atorvastatin Impurity 129 (CAS 873950-17-5)
- Atorvastatin Impurity 156 (CAS CATO-C4X-1132156)
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