Solifenacin EP Impurity H HCl CAS 180468-38-6
| CAS No. | 180468-38-6 |
| Molecular Formula | C23H26N2O2 |
| Molecular Weight | N/A |
| 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.
Solifenacin EP Impurity H HCl (CAS 180468-38-6) is a certified pharmaceutical impurity reference standard with the molecular formula C23H26N2O2HCl and a molecular weight of 398.93 g/mol.
Based on its molecular formula C23H26N2O2HCl, Solifenacin EP Impurity H HCl contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 398.93 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a certified reference material (CRM), Solifenacin EP Impurity H HCl 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 | C23H26N2O2 HCl |
| Molecular Weight | 398.93 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2008 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Solifenacin Standards
- Solifenacin Impurity 19 (CAS 1029430-94-1)
- Solifenacin Impurity 8 (HCl) (CAS 1159826-34-2)
- Solifenacin EP Impurity A (CAS 118864-75-8)
- Solifenacin Impurity 31 (CAS 1193-65-3)
- Solifenacin Impurity 28 (CAS 120577-33-5)
- Solifenacin Impurity 34 (CAS 1243274-81-8)
- Solifenacin Impurity 16 (CAS 134021-15-1)
- Solifenacin EP Impurity B (CAS 1353274-25-5)
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- 4-Amino-2-phenyl-1H-imidazole-5-carboxamide (CAS 41631-74-7)
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