Atorvastatin Impurity 106 CAS 1316291-19-6
| CAS No. | 1316291-19-6 |
| Molecular Formula | C33H34FN2O7 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 612.63 g/mol gives Atorvastatin Impurity 106 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Atorvastatin Impurity 106 (CAS 1316291-19-6) is a certified pharmaceutical impurity reference standard with the molecular formula C33H34FN2O7Na and a molecular weight of 612.63 g/mol.
Atorvastatin Impurity 106 (C33H34FN2O7Na) 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 | C33H34FN2O7 Na |
| Molecular Weight | 612.63 g/mol |
| Purity | >95% |
| 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) | 17.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1990 |
| 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
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- Hesperidin Impurity 8 (CAS CATO-C4X-33278)
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- Methyl 4-(4-oxopiperidin-1-yl)butanoate (CAS 1096321-89-9)
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- (Pro30,Tyr32,Leu34)-Neuropeptide Y (28-36) (CAS 161650-01-7)
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