Ivabradine Impurity 32 CAS CATO-C4X-111932
| CAS No. | CATO-C4X-111932 |
| Molecular Formula | C27H34N2O6 |
| Molecular Weight | 482.57 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 Ivabradine Impurity 32.
As a process- or degradation-related impurity, Ivabradine Impurity 32 (CAS CATO-C4X-111932, C27H34N2O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Ivabradine Impurity 32 (C27H34N2O6) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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), Ivabradine 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 | C27H34N2O6 |
| Molecular Weight | 482.57 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 2 |
Related Ivabradine Standards
- Ivabradine Impurity 15 (CAS CATO-C4X-111915)
- Ivabradine Impurity 19 (CAS 2731089-65-7)
- Ivabradine impurity 62 (CAS CATO-C4X-111962)
- Ivabradine impurity N1 (CAS 2511244-96-3)
- Ivabradine Impurity 14 (CAS CATO-C4X-111914)
- Ivabradine Impurity 42 (CAS 2511244-97-4)
- Ivabradine Impurity 6 (CAS 2253977-80-7)
- Ivabradine Impurity 68 (CAS CATO-C4X-111968)
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