| CAS No. | 110129-10-7 |
| Molecular Formula | C16H32N2O |
| Molecular Weight | 268.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a process- or degradation-related impurity, Pitolisant impurity 22 (CAS 110129-10-7, C16H32N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to an amide group, a hydroxyl group, an ether linkage, Pitolisant impurity 22 is typically white to off-white low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 268.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C16H32N2O |
| Molecular Weight | 268.44 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1988 |
| Nitrogen Atoms | 2 |