Atorvastatin Calcium EP Impurity J CAS 1105067-93-3
| CAS No. | 1105067-93-3 |
| Molecular Formula | C33H32FN2O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 562.62 g/mol gives Atorvastatin Calcium EP Impurity J distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Atorvastatin Calcium EP Impurity J (CAS 1105067-93-3) is a certified pharmaceutical impurity reference standard with the molecular formula C33H32FN2O4Na and a molecular weight of 562.62 g/mol.
The molecular framework of Atorvastatin Calcium EP Impurity J (C33H32FN2O4Na) 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. 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 Calcium EP Impurity J 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 | C33H32FN2O4 Na |
| Molecular Weight | 562.62 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >90% |
| 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) | 18.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1989 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Atorvastatin Standards
- Atorvastatin Impurity 22 (CAS 1035205-25-4)
- Atorvastatin Calcium Propylene Glycol Solvate (CAS 1040350-07-9)
- Atorvastatin Lactone Diepoxide (CAS 1046118-40-4)
- Atorvastatin Lactam calcium Salt Impurity (CAS 1046118-41-5)
- Atorvastatin Impurity 86 (CAS 1046118-44-8)
- Atorvastatin Impurity 141 Calcium Salt (CAS 1046378-58-8)
- Atorvastatin Impurity 76 (CAS 1099474-28-8)
- Atorvastatin EP Impurity F(Calcium Salt) (CAS 1105067-87-5)
Recommended Standards
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- 2,7-Dioctylbenzo[lmn][3,8]phenanthroline-1,3,6,8(2H,7H)-tetraone (CAS 34155-21-0)
- N-Cyclohexyl-2-((3-(4-fluorophenyl)-[1,2,4]triazolo[4,3-b]pyridazin-6-yl)thio)acetamide (CAS 852374-07-3)
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- 1-(4-Fluorophenyl)ethanamine HCl (CAS 403-37-2)
- N-Benzyl-6-ethyl-1,3-benzothiazol-2-amine (CAS 1105191-56-7)
- Urotensin II-Related Peptide (human, mouse, rat) (CAS 342878-90-4)
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