Pitolisant impurity 02 CAS 157355-75-4
| CAS No. | 157355-75-4 |
| Molecular Formula | C21H24N2O4 |
| Molecular Weight | 368.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Pitolisant impurity 02 (CAS 157355-75-4, C21H24N2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Pitolisant impurity 02 (C21H24N2O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
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 | C21H24N2O4 |
| Molecular Weight | 368.43 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| 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 |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2001 |
| Nitrogen Atoms | 2 |
Related Pitolisant Standards
- Pitolisant Impurity 42 (CAS CATO-C4X-252042)
- Pitolisant Impurity 43 (CAS 85356-69-0)
- Pitolisant impurity 11 (CAS CATO-C4X-252011)
- Pitolisant Impurity 46 (CAS CATO-C4X-252046)
- Pitolisant Impurity 1 (CAS CATO-C4X-25201)
- Pitolisant impurity 23 (CAS CATO-C4X-252023)
- Pitolisant impurity 26 (CAS CATO-C4X-252026)
- Pitolisant impurity 29 (CAS CATO-C4X-252029)
Recommended Standards
- 2,2′-(1,4-Phenylene)bis[4,5-dihydro-5-phenyloxazole] (CAS 15502-52-0)
- 2-(1-Trityl-1H-imidazol-4-yl)acetic acid (CAS 168632-03-9)
- 8-Hydroxy-5-((R)-1-hydroxy-2-(((R)-1-(4-methoxyphenyl)propan-2-yl)amino)ethyl)quinolin-2(1H)-one (CAS 147568-66-9)
- tert-Butyl 3-{[3-(ethylcarbamoyl)phenyl]carbamoyl}benzoate (CAS 1797392-11-0)
- Everolimus Impurity 16 (CAS 147438-29-7)
- Rosiglitazone Impurity 6 (CAS CATO-C4X-21796)
- Benzhexol Impurity 3 (CAS CATO-C4X-18573)
- Xilobam (CAS 50528-97-7)
- 2-(2-Chlorophenyl)-2-(diethylamino)acetic acid hydrochloride (CAS 1956309-83-3)
- 6-(1,3-Dioxopropan-2-yl)picolinic acid (CAS 212755-80-1)
- ((1S,9AS)-octahydro-2H-quinolizin-1-yl)methanol (CAS 7635-60-1)
- 2-(4-Bromo-2,6-dimethylphenoxy)acetic acid (CAS 455887-97-5)
- 312693-06-4 3-Fluorobenzylzinc chloride, 0.5M in THF MFCD01319878 (CAS 312693-06-4)
- Acetyl Dipeptide-1 (CAS 196604-48-5)
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