Pitavastatin Impurity 53 CAS CATO-C4X-103753
| CAS No. | CATO-C4X-103753 |
| Molecular Formula | C32H37NO4 |
| Molecular Weight | 499.64 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Pitavastatin Impurity 53 (C32H37NO4) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a process- or degradation-related impurity, Pitavastatin Impurity 53 (CAS CATO-C4X-103753, C32H37NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
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 | C32H37NO4 |
| Molecular Weight | 499.64 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
Related Pitavastatin Standards
- Pitavastatin Impurity 134 (CAS CATO-C4X-1037134)
- Pitavastatin Impurity 132 (CAS CATO-C4X-1037132)
- Pitavastatin Impurity 133 (CAS CATO-C4X-1037133)
- Pitavastatin Impurity 65 (CAS CATO-C4X-103765)
- Pitavastatin Impurity 64 (CAS CATO-C4X-103764)
- Pitavastatin Impurity 10(R,R) (CAS CATO-C4X-103710)
- Pitavastatin Impurity 39 (CAS 154170-27-1)
- Pitavastatin Impurity 5 (CAS 147489-06-3)
Recommended Standards
- O-[4-(2-Dimethylaminoethoxy)-trans-cinnamoyl]fumagillol (CAS 251111-30-5)
- Venlafaxine Impurity 63 (CAS 916918-90-6)
- Dichlorobis(3-amino-2H-1-benzopyran-2-one-N)dichloropalladium (CAS 76295-00-6)
- Fexofenadine EP Impurity A (CAS 76811-98-8)
- Nabumetone Impurity 23 (CAS 56290-45-0)
- Vonoprazan Impurity 155 (CAS 403710-57-6)
- Isavuconazole Impurity 38 (CAS 32399-12-5)
- Praseodymium(III) hexafluoroacetylacetonate hydrate (CAS 307531-71-1)
- 1-Ethyl-5-fluoro-1H-1,3-benzodiazol-2-amine (CAS 1155599-04-4)
- 2-(4-Bromo-2-fluoro-5-nitrophenyl)-1,2-dihydro-5-methyl-3H-1,2,4-triazol-3-one (CAS 100563-50-6)
- 5-Chloro-2-methoxy-4-methylpyridine (CAS 851607-29-9)
- Tert-butyl (S)-3-((methylsulfonyl)methyl)piperidine-1-carboxylate (CAS 1008562-82-0)
- N-(3-Hydroxypropyl)-4-((4-oxo-3,5,6,7-tetrahydro-4H-cyclopenta[4,5]thieno[2,3-d]pyrimidin-2-yl)thio)butanamide (CAS 433699-92-4)
- Proinsulin C-Peptide (55-89) (human) (CAS 11097-48-6)
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