Tolvaptan Impurity 97 CAS 1030654-92-2
| CAS No. | 1030654-92-2 |
| Molecular Formula | C16H15NO3 |
| Molecular Weight | 269.30 g/mol |
| 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 Tolvaptan Impurity 97.
As a process- or degradation-related impurity, Tolvaptan Impurity 97 (CAS 1030654-92-2, C16H15NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Tolvaptan Impurity 97 (C16H15NO3) 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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), Tolvaptan Impurity 97 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 | C16H15NO3 |
| Molecular Weight | 269.30 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 chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1988 |
| Nitrogen Atoms | 1 |
Related Tolvaptan Standards
- Tolvaptan Impurity 28 (CAS 317374-08-6)
- Tolvaptan Impurity 53 (CAS CATO-C4X-195553)
- Tolvaptan Impurity 63 (CAS CATO-C4X-195563)
- Tolvaptan Impurity 81 (CAS 1118884-67-5)
- Tolvaptan Impurity 82 (CAS 1306528-12-0)
- Tolvaptan Impurity 5 (CAS CATO-C4X-19555)
- Tolvaptan Impurity 119 (CAS CATO-C4X-1955119)
- Tolvaptan Impurity 54 (CAS 1118884-66-4)
Recommended Standards
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- Z-Tyr-Val-OH (C-2800.0005) (CAS 38972-89-3)
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