Proparacaine Impurity 8 HCl CAS 35288-46-1
| CAS No. | 35288-46-1 |
| Molecular Formula | C16H24N2O5 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Proparacaine Impurity 8 HCl (CAS 35288-46-1) is a certified pharmaceutical impurity reference standard with the molecular formula C16H24N2O5HCl and a molecular weight of 360.83 g/mol.
Based on its molecular formula C16H24N2O5HCl, Proparacaine Impurity 8 HCl contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 360.83 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C16H24N2O5 HCl |
| Molecular Weight | 360.83 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| 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; 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.) | 1967 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Proparacaine Standards
- Proparacaine Impurity N1 (CAS 100811-81-2)
- Proparacaine Impurity 25 HCl (CAS 1081544-05-9)
- Proparacaine Impurity 20 (CAS 1216179-28-0)
- Proparacaine Impurity 16 (CAS 15788-85-9)
- Proparacaine Impurity 15 (CAS 2102411-30-1)
- Proparacaine Impurity 23 HCl (CAS 2102411-30-1(Free Base))
- Proparacaine Impurity 17 (CAS 2731368-98-0)
- Proparacaine Impurity 5 DiHCl (CAS 2731368-99-1)
Recommended Standards
- Ioversol Impurity 21 (CAS CATO-C4X-209121)
- Ifosfamide EP Impurity A (CAS 22608-58-8)
- Bepotastine Impurity 9 (CAS CATO-C4X-18399)
- 4,6-Dichloro-2-(4-nitrophenyl)pyrimidine (CAS 83217-23-6)
- Carteolol Hydrochloride EP Impurity B (CAS 30389-33-4)
- 2,6-Dihydroxy-5-methoxy-4-methylnicotinonitrile (CAS 1704065-88-2)
- 1-(1,3-Dimethyl-1H-pyrazol-5-yl)-N-((1-(2,2,2-trifluoroethyl)-1H-pyrazol-5-yl)methyl)methanamine hydrochloride (CAS 1856070-59-1)
- 5-chloro-7-methyl-[1,2,4]triazolo[1,5-a]pyridine (CAS 878259-99-5)
- tert-Butyl methyl(3-(oxiran-2-yl)propyl)carbamate (CAS 497107-76-3)
- Semaglutide impurity 109 (CAS CATO-C4X-2226109)
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