Pitavastatin Impurity 35 CAS CATO-C4X-103735
| CAS No. | CATO-C4X-103735 |
| Molecular Formula | C25H23FNO4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pitavastatin Impurity 35.
Pitavastatin Impurity 35 (CAS CATO-C4X-103735) is a certified pharmaceutical impurity reference standard with the molecular formula C25H23FNO4Ca and a molecular weight of 460.54 g/mol.
Structurally, Pitavastatin Impurity 35 (C25H23FNO4Ca) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 14.5, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 460.54 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
As a certified reference material (CRM), Pitavastatin Impurity 35 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C25H23FNO4 Ca |
| Molecular Weight | 460.54 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 14.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Pitavastatin Standards
- Pitavastatin Impurity 92 (CAS 1159588-21-2)
- Pitavastatin Impurity 112 (CAS 1187966-91-1)
- Pitavastatin Impurity 90 (CAS 1187966-91-1（free base）)
- Pitavastatin Impurity 51 (CAS 1187966-93-3)
- Pitavastatin Impurity 55 (CAS 1187966-94-4)
- Pitavastatin Impurity 54 (CAS 1187966-95-5)
- Pitavastatin Impurity 40 (CAS 121659-86-7)
- Pitavastatin Impurity 96 (CAS 121660-11-5)
Recommended Standards
- Nintedanib Impurity 170 (CAS CATO-C4X-1814170)
- Imidapril Impurity 11 (CAS CATO-C4X-243911)
- Nemonoxacin Impurity 25 (CAS 221221-15-4)
- 2-methylquinolin-6-ol (CAS 613-21-8)
- Empagliflozin Impurity 151 (CAS CATO-C4X-1065151)
- 3-Ethylphenyl isocyanate 1-ethyl-3-isocyanato-benzene 1-ethyl-3-isocyanatobenzene 23138-58-1 (CAS 23138-58-1)
- Isothiazolo[4,5-c]pyridin-3-amine (CAS 1367990-09-7)
- Methyl 1-hydroxy-2-methyl-2,3-dihydro-1H-indene-2-carboxylate (CAS 1227796-57-7)
- 4-chloro-2,5-dimethylthieno[2,3-d]pyrimidine (CAS 935843-18-8)
- Acetyl Hexapeptide-38 (CAS 1400634-44-7)
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