Pitavastatin Impurity 82 CAS 782-01-4
| CAS No. | 782-01-4 |
| Molecular Formula | C13H10FNO |
| Molecular Weight | 215.22 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Pitavastatin Impurity 82 (CAS 782-01-4, C13H10FNO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Pitavastatin Impurity 82 (C13H10FNO) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C13H10FNO |
| Molecular Weight | 215.22 g/mol |
| Purity | >95% |
| 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.) | 1957 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Pitavastatin Standards
- Pitavastatin Impurity 19 (CAS 3800-06-4)
- Pitavastatin Impurity 105 (CAS CATO-C4X-1037105)
- Pitavastatin Impurity 83 (CAS CATO-C4X-103783)
- Pitavastatin Impurity 80 (CAS CATO-C4X-103780)
- Pitavastatin Impurity 104 (CAS CATO-C4X-1037104)
- Pitavastatin Impurity 131 (CAS CATO-C4X-1037131)
- Pitavastatin Impurity 79 (CAS 2153433-73-7)
- Pitavastatin Impurity 97 (CAS 1356998-79-2)
Recommended Standards
- tert-Butyl 3-(1-fluoro-2-oxoethylidene)azetidine-1-carboxylate (CAS 2383712-87-4)
- Ezetimibe Impurity 108 (CAS 2304449-25-8)
- rel-(2S,7aR)-Ethyl 2-fluoro-5-oxohexahydro-1H-pyrrolizine-7a-carboxylate (CAS 2454498-75-8)
- Ezetimibe Impurity 123 (CAS 3382-62-5)
- Amoxicillin Impurity 35 (CAS CATO-C4X-114835)
- Bepotastine Impurity 29 (CAS 2469626-70-6)
- Diphenhydramine impurity 17 (CAS 22808-17-9)
- Nefopam Impurity 39 (CAS CATO-C4X-283739)
- 3-(3-(3-Bromophenyl)-2,5-dioxoimidazolidin-1-yl)benzoic acid (CAS 651748-59-3)
- 1-Bromo-2-fluoro-4-(prop-2-yn-1-yloxy)benzene (CAS 1483672-33-8)
- 3,5-Dibutyl-4H-1,2,4-triazol-4-amine (CAS 62695-58-3)
- ((3S,4R)-4-Methyl-4-phenylpyrrolidin-3-yl)methanol hydrochloride (CAS 1354487-02-7)
- N,N-Dimethyl-L-Tryptophan (CAS 2812-40-0)
- Compstatin control peptide (CAS 301544-78-5)
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