| CAS No. | 52669-92-8 (free base) |
| Molecular Formula | C21H21ClFNO |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a process- or degradation-related impurity, Haloperidol Impurity 38 HCl (CAS 52669-92-8 (free base), C21H21ClFNOHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Haloperidol Impurity 38 HCl (C21H21ClFNOHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; 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.
| Molecular Formula | C21H21ClFNO HCl |
| Molecular Weight | 394.31 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 1 |