Atorvastatin impurity 158 CAS 1421760-64-6
| CAS No. | 1421760-64-6 |
| Molecular Formula | C33H36FN2O6 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Atorvastatin impurity 158 (CAS 1421760-64-6, C33H36FN2O6NaH2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Atorvastatin impurity 158 (C33H36FN2O6NaH2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C33H36FN2O6 Na 2*H2O |
| Molecular Weight | 616.66 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°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) | 15.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Atorvastatin Standards
- Atorvastatin Impurity 22 (CAS 1035205-25-4)
- Atorvastatin Calcium Propylene Glycol Solvate (CAS 1040350-07-9)
- Atorvastatin Lactone Diepoxide (CAS 1046118-40-4)
- Atorvastatin Lactam calcium Salt Impurity (CAS 1046118-41-5)
- Atorvastatin Impurity 86 (CAS 1046118-44-8)
- Atorvastatin Impurity 141 Calcium Salt (CAS 1046378-58-8)
- Atorvastatin Impurity 76 (CAS 1099474-28-8)
- Atorvastatin EP Impurity F(Calcium Salt) (CAS 1105067-87-5)
Recommended Standards
- Cefuroxime Impurity 79 (CAS CATO-C4X-124579)
- Olprinone Impurity 11 (CAS CATO-C4X-204311)
- Difelikefalin Impurity 86 (CAS CATO-C4X-304186)
- Bicyclo[2.2.1]hept-5-en-2-ylmethyl acrylate (CAS 95-39-6)
- (R)-1-(3-chloro-5-fluorophenyl)-2-methylpropan-1-amine (CAS 1213531-95-3)
- 2-Hydroxy Fluorene-d9 (CAS 922510-18-7)
- (3S)-3-methylpiperidin-3-ol (CAS 1200132-32-6)
- Quinoline-7-sulfonic acid (CAS 65433-96-7)
- (E)-(2-Cyclohexylvinyl)boronic Acid (CAS 37490-33-8)
- Semaglutide impurity 85 (CAS CATO-C4X-222685)
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