Atorvastatin EP Impurity F CAS 1371615-56-3
| CAS No. | 1371615-56-3 |
| Molecular Formula | C40H48FN3O8 |
| Molecular Weight | 717.82 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 EP Impurity F.
Atorvastatin EP Impurity F (CAS 1371615-56-3) is a certified pharmaceutical impurity reference standard with the molecular formula C40H48FN3O8 and a molecular weight of 717.82 g/mol.
Structurally, Atorvastatin EP Impurity F (C40H48FN3O8) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 18.0, corresponding to approximately 18 ring(s) or double-bond equivalent(s). With a molecular weight of 717.82 g/mol, it falls into the 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), Atorvastatin EP Impurity F 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 | C40H48FN3O8 |
| Molecular Weight | 717.82 g/mol |
| Purity | 97%+ |
| 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.) | 1991 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Atorvastatin Standards
- Atorvastatin Calcium EP Impurity F (CAS 887196-24-9)
- Atorvastatin Acyl-beta-D-glucuronide (CAS 463962-58-5)
- Atorvastatin Impurity 67 (CAS 693793-87-2)
- Atorvastatin 3-Isopropyl Ether tert-Butyl Ester (CAS 1797009-04-1)
- Atorvastatin Impurity 76 (CAS 1099474-28-8)
- Atorvastatin EP Impurity I (CAS 125971-95-1)
- Atorvastatin Impurity 24 (CAS 472967-95-6)
- Atorvastatin Impurity 66 (CAS 1105067-90-0)
Recommended Standards
- Levothyroxine EP Impurity I (CAS 2016-06-0)
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- Itraconazole Impurity 19 (CAS CATO-C4X-149719)
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- 1-Bromo-4-(3,3,3-trifluoroprop-1-en-2-yl)benzene (CAS 136476-20-5)
- NNC 55-0396 (Racemic Mixture) (CAS 357400-13-6)
- 1-(4-Fluorobenzyl)-2-(pyrrolidin-3-ylmethoxy)-1H-benzo[d]imidazole hydrochloride (CAS 1353966-61-6)
- 2-Cyanobenzo[b]thiophene-3-sulfonamide (CAS 1334651-28-3)
- N-cyclopentyl-5-methylisoxazole-3-carboxamide (CAS 135401-66-0)
- 6-Ethylbenzo[d]thiazole, 97% (CAS 118220-72-7)
- Tirzepatide Impurity 20 (CAS CATO-C4X-324020)
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