Rosuvastatin impurity 246 CAS 894788-00-2
| CAS No. | 894788-00-2 |
| Molecular Formula | C15H17ClFN3O2S |
| Molecular Weight | 357.83 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Rosuvastatin impurity 246 (CAS 894788-00-2) is a certified pharmaceutical impurity reference standard with the molecular formula C15H17ClFN3O2S and a molecular weight of 357.83 g/mol.
The molecular framework of Rosuvastatin impurity 246 (C15H17ClFN3O2S) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine 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.
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 | C15H17ClFN3O2S |
| Molecular Weight | 357.83 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 3 |
| Sulfur Atoms | 1 |
Related Rosuvastatin Standards
- Rosuvastatin Impurity 170 (CAS CATO-C4X-1169170)
- Rosuvastatin Impurity 83 (CAS 147118-36-3)
- Rosuvastatin Impurity 93 (CAS CATO-C4X-116993)
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- Rosuvastatin Impurity 109 (CAS 799842-06-1)
- Rosuvastatin Impurity 153 (CAS CATO-C4X-1169153)
- Rosuvastatin Impurity 106 (CAS 147118-37-4)
- Rosuvastatin Impurity 227 (CAS CATO-C4X-1169227)
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