Atorvastatin Impurity N4 CAS 62148-67-8
| CAS No. | 62148-67-8 |
| Molecular Formula | C14H10ClFO |
| Molecular Weight | 248.68 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Atorvastatin Impurity N4 (CAS 62148-67-8, C14H10ClFO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a hydroxyl group, an ether linkage, fluorine/chlorine substitution, a polycyclic aromatic system, Atorvastatin Impurity N4 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 248.68 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C14H10ClFO |
| Molecular Weight | 248.68 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1974 |
| Halogen Content | F/Cl-containing |
Related Atorvastatin Standards
- Atorvastatin impurity 163 (CAS 131000-98-1)
- Atorvastatin Impurity 167 (CAS CATO-C4X-1132167)
- Atorvastatin impurity 165 (CAS CATO-C4X-1132165)
- Atorvastatin impurity 160 (CAS 1112262-76-6)
- Atorvastatin Impurity 151 (CAS 737755-14-5)
- Atorvastatin Impurity 150 (CAS 676260-66-5)
- Atorvastatin Impurity 32 (CAS 186508-94-1)
- Atorvastatin Impurity 62 (CAS 125971-93-9)
Recommended Standards
- 5-Chloro-7-fluoro-2-(pyridin-4-yl)indoline (CAS 593234-03-8)
- ethyl 3-(chlorosulfonyl)benzoate (CAS 217453-46-8)
- 5-Chloro-7-fluoro-2-(pyridin-3-yl)indoline (CAS 593234-02-7)
- Methyl 2-(3-(chlorosulfonyl)phenyl)acetate (CAS 259191-92-9)
- Sorafenib EP Impurity H (CAS 1431697-81-2)
- Vilanterol Impurity 93 (CAS CATO-C4X-193593)
- Trimethoprim EP Impurity D (CAS 92440-76-1)
- 5-Bromo-N-(2-(pyrrolidin-1-yl)propyl)nicotinamide (CAS 1241067-53-7)
- Urapidil Impurity 54 (CAS 13300-33-9)
- 3-(Difluoromethyl)-2-methoxypyridine (CAS 1804659-97-9)
- (2,5-Dimethylphenyl)(piperazin-1-yl)methanone (CAS 1016690-70-2)
- Neratinib Impurity 57 (CAS CATO-C4X-113457)
- Gadobutrol Impurity 37 (CAS CATO-C4X-2120137)
- Semaglutide impurity 43 (CAS CATO-C4X-222643)
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