Simvastatin EP Impurity I CAS 79902-42-4
| CAS No. | 79902-42-4 |
| Molecular Formula | C23H34O5 |
| Molecular Weight | 390.51 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Simvastatin EP Impurity I (CAS 79902-42-4, C23H34O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Simvastatin EP Impurity I (C23H34O5) is characterized by a flavonoid 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 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.
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 | C23H34O5 |
| Molecular Weight | 390.51 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1979 |
Related Simvastatin Standards
- Simvastatin Impurity 22 (CAS CATO-C4X-119922)
- Simvastatin EP Impurity C (CAS 210980-68-0)
- Simvastatin EP Impurity E (CAS 75330-75-5)
- Simvastatin EP Impurity F (CAS 79952-44-6)
- Simvastatin Impurity I (CAS 121624-18-8)
- Simvastatin EP Impurity G (CAS 1449248-72-9)
- Simvastatin (CAS 79902-63-9)
- Simvastatin EP Impurity K (CAS CATO-C4X-119913)
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- Amoxicillin Impurity 44 (CAS CATO-C4X-114844)
- Finerenone Impurity 174 (CAS CATO-C4X-2880174)
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