Mizolastine impurity 11 CAS CATO-C4X-200611
| CAS No. | CATO-C4X-200611 |
| Molecular Formula | C23H23FN6O |
| Molecular Weight | 418.47 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 Mizolastine impurity 11.
Mizolastine impurity 11 (CAS CATO-C4X-200611) is a certified pharmaceutical impurity reference standard with the molecular formula C23H23FN6O and a molecular weight of 418.47 g/mol.
Mizolastine impurity 11 (C23H23FN6O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C23H23FN6O |
| Molecular Weight | 418.47 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 6 |
Related Mizolastine Standards
- Mizolastine Impurity 10 (CAS CATO-C4X-200610)
- Mizolastine Impurity 3 (CAS CATO-C4X-20063)
- Mizolastine Impurity 4 (CAS 935860-15-4)
- Mizolastine (CAS 108612-45-9)
- Mizolastine Impurity N1 (CAS 108612-60-8)
- Mizolastine Impurity 9 (CAS CATO-C4X-20069)
- Mizolastine impurity 16 (CAS CATO-C4X-200616)
- Mizolastine impurity 12 (CAS CATO-C4X-200612)
Recommended Standards
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- Etomidate Impurity 18 (CAS CATO-C4X-188418)
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