Iptacopan Impurity 3 CAS 1387445-50-2
| CAS No. | 1387445-50-2 |
| Molecular Formula | C15H19NO3 |
| Molecular Weight | 261.32 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Iptacopan Impurity 3 (C15H19NO3) 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 its high hydrophobicity (logP), 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, Iptacopan Impurity 3 (CAS 1387445-50-2, C15H19NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 certified reference material (CRM), Iptacopan Impurity 3 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 | C15H19NO3 |
| Molecular Weight | 261.32 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Nitrogen Atoms | 1 |
Related Iptacopan Standards
- Iptacopan Impurity 4 (CAS 1644667-61-7)
- Iptacopan Impurity 5 (CAS 3040999-15-0)
- Iptacopan (CAS 1644670-37-0)
- Iptacopan Impurity 6 (CAS CATO-C4X-32646)
- Iptacopan Impurity 7 (CAS 1644670-76-7)
- Iptacopan Hydrochloride (CAS 1646321-63-2)
- Iptacopan Impurity 10 (CAS CATO-C4X-326410)
- Iptacopan Impurity 8 (CAS CATO-C4X-32648)
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