| CAS No. | 854306-72-2 |
| Molecular Formula | C35H41NO2 |
| Molecular Weight | 507.71 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Tolterodine Impurity 9 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.
As a process- or degradation-related impurity, Tolterodine Impurity 9 (CAS 854306-72-2, C35H41NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Tolterodine Impurity 9 (C35H41NO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 16.0, corresponding to approximately 16 ring(s) or double-bond equivalent(s). With a molecular weight of 507.71 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).
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.
| Molecular Formula | C35H41NO2 |
| Molecular Weight | 507.71 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| 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) | 16.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 1 |