Simvastatin Impurity 26 CAS CATO-C4X-119926
| CAS No. | CATO-C4X-119926 |
| Molecular Formula | C25H40O5 |
| Molecular Weight | 420.58 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Simvastatin Impurity 26 (CAS CATO-C4X-119926, C25H40O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Simvastatin Impurity 26 (C25H40O5) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C25H40O5 |
| Molecular Weight | 420.58 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
Related Simvastatin Standards
- Simvastatin EP Impurity K (CAS CATO-C4X-119913)
- Simvastatin Impurity 27 (CAS 132487-01-5)
- Simvastatin impurity 30 (CAS 92083-03-9)
- Simvastatin D3 (CAS 1002347-61-6)
- Simvastatin (CAS 79902-63-9)
- Simvastatin-d6 (CAS 1002347-71-8)
- Simvastatin Impurity I (CAS 121624-18-8)
- Simvastatin EP Impurity G (CAS 1449248-72-9)
Recommended Standards
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- (4-Methyl-2-((tetrahydrofuran-2-yl)methoxy)phenyl)methanamine (CAS 1250081-20-9)
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