Paliperidone Impurity 101 Hydrochloride CAS 81043-50-7
| CAS No. | 81043-50-7 |
| Molecular Formula | C12H14FNO2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Paliperidone Impurity 101 Hydrochloride (CAS 81043-50-7, C12H14FNO2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C12H14FNO2HCl, Paliperidone Impurity 101 Hydrochloride contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 259.70 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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.
Physical & Chemical Properties
| Molecular Formula | C12H14FNO2 HCl |
| Molecular Weight | 259.70 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1980 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 1 |
Related Paliperidone Standards
- Paliperidone Impurity 16 (CAS 1006685-69-3)
- Paliperidone Impurity 49 (CAS 1008796-22-2)
- Paliperidone Impurity 46 (CAS 1008796-23-3)
- Paliperidone-d4 (CAS 1020719-55-4)
- Paliperidone Impurity 61 (CAS 1138463-56-5)
- Paliperidone Impurity 32 (CAS 1141761-80-9)
- Paliperidone Impurity 161 (CAS 1160611-32-4)
- Paliperidone Impurity 36 (CAS 1160915-55-8)
Recommended Standards
- N-Nitroso Omadacycline lmpurity 1 (CAS CATO-C4X-285722)
- Carbachol Impurity 2 (CAS CATO-C4X-34012)
- Isavuconazole Impurity 204 (CAS CATO-C4X-1236204)
- Potassium trifluoro(pivaloyl)borate (CAS 2215102-00-2)
- 2-Amino-4-(benzyloxy)-5-methoxybenzaldehyde (CAS 82583-95-7)
- 3’-O-Methyluridine (CAS 6038-59-1)
- 1-(2,6,6-Trimethylcyclohex-1-en-1-yl)pent-1-en-3-one (CAS 127-43-5)
- 5-Chloro-2-hydroxy-N,N-dimethylbenzamide (CAS 70112-21-9)
- Melarsen Oxide (CAS 21840-08-4)
- [Ser39-OH] Tirzepatide (CAS CATO-C4X-324041)
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