Simvastatin EP Impurity D CAS 476305-24-5
| CAS No. | 476305-24-5 |
| Molecular Formula | C50H76O10 |
| Molecular Weight | 837.13 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Based on its molecular formula C50H76O10, Simvastatin EP Impurity D contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 837.13 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a process- or degradation-related impurity, Simvastatin EP Impurity D (CAS 476305-24-5, C50H76O10) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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), Simvastatin 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 | C50H76O10 |
| Molecular Weight | 837.13 g/mol |
| Purity | >85% |
| 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 |
| Degree of Unsaturation (DBE) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
Related Simvastatin Standards
- Simvastatin Impurity 17 (CAS CATO-C4X-119917)
- Simvastatin Impurity 18 (CAS CATO-C4X-119918)
- Simvastatin, 1-Pyreneacetyl Ester (CAS 193682-18-7)
- Simvastatin Acyl-β-D-glucuronide (CAS 463962-56-3)
- Simvastatin Impurity 19 (CAS CATO-C4X-119919)
- Simvastatin Impurity 16 (CAS CATO-C4X-119916)
- Simvastatin Impurity 20 (CAS CATO-C4X-119920)
- Simvastatin Impurity M (CAS 1796930-96-5)
Recommended Standards
- (R)-4-Hydroxy-2,6-bis(2,4,6-tri-tert-butylphenyl)dinaphtho[2,1-d:1',2'-f][1,3,2]dioxaphosphepine 4-oxide (CAS 1821241-72-8)
- Auristatin Impurity 2-d4 (CAS 3078487-03-0(non-deuterated))
- Bis[3-[1-(4-Carboxyphenyl)-5-(2-hydroxyphenyl)-1H-1,2,4-triazol-3-yl]-4-hydroxyphenyl] Sulfoxide (CAS 1688656-84-9)
- 4,4′,4′′′,4′″-(porphyrin-5,10,15,20-tetrakis(benzoic acid) (CAS 14609-54-2)
- Tigecycline Impurity 20 (CAS 866602-58-6)
- Tafamidis Impurity 15 (CAS CATO-C4X-287715)
- Peramivir Impurity 96 (CAS CATO-C4X-183396)
- (4-(1H-imidazol-1-yl)-2-(trifluoromethyl)phenyl)boronic acid (CAS 2225179-45-1)
- 16499-54-0 2-Amino-5-(trifluoromethyl)benzamide C8H7F3N2O V3661 (CAS 16499-54-0)
- 3-Cyano-N-(4-(3-(trifluoromethyl)phenoxy)but-2-yn-1-yl)benzamide (CAS 1421513-23-6)
- (Cyclopropylmethyl)({[2-(trifluoromethyl)phenyl]methyl})amine (CAS 1019538-83-0)
- (Bicyclo[3.1.0]hexane-1,5-diyl)dimethanol (CAS 103478-23-5)
- tert-Butyl 4-bromo-2-fluorobenzyl(cyclopropyl)carbamate (CAS 1704095-31-7)
- (D-His1)-Exenatide trifluoroacetate salt (CAS 1678417-09-8)
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