Pemafibrate Impurity 32 CAS CATO-C4X-290332
| CAS No. | CATO-C4X-290332 |
| Molecular Formula | C20H27NO4 |
| Molecular Weight | 345.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Pemafibrate Impurity 32 (CAS CATO-C4X-290332, C20H27NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Pemafibrate Impurity 32 (C20H27NO4) is characterized by a flavonoid core, 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 certified reference material (CRM), Pemafibrate Impurity 32 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 | C20H27NO4 |
| Molecular Weight | 345.43 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
Related Pemafibrate Standards
- Pemafibrate Impurity 50 (CAS CATO-C4X-290350)
- Pemafibrate Impurity 49 (CAS CATO-C4X-290349)
- Pemafibrate Impurity 2 (CAS CATO-C4X-29032)
- Pemafibrate Impurity 44 (CAS CATO-C4X-290344)
- Pemafibrate Impurity 51 (CAS CATO-C4X-290351)
- Pemafibrate Impurity 30 (CAS CATO-C4X-290330)
- Pemafibrate Impurity 21 (CAS CATO-C4X-290321)
- Pemafibrate Impurity 23 (CAS CATO-C4X-290323)
Recommended Standards
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- Bevantolol Impurity 26 (CAS CATO-C4X-241126)
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