Proparacaine Impurity 35 CAS CATO-C4X-202735
| CAS No. | CATO-C4X-202735 |
| Molecular Formula | C13H19NO5 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Proparacaine Impurity 35 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Proparacaine Impurity 35 (CAS CATO-C4X-202735, C13H19NO5HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C13H19NO5HCl, Proparacaine Impurity 35 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 305.75 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.
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 | C13H19NO5 HCl |
| Molecular Weight | 305.75 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
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
- Caspofungin Impurity 51 Acetate Salt (CAS CATO-C4X-157551)
- Nintedanib Impurity N24 (CAS 1139455-52-9)
- Iopamidol Impurity 17 (CAS 1794-90-7)
- 933719-67-6 3-(4,5-Dimethyl-1H-benzimidazol-2-yl)-1-propanamine dihydrochloride hydrate MFCD18483519 (CAS 933719-67-6)
- 3-(1,3-Dimethyl-1h-pyrazol-5-yl)propanenitrile (CAS 1482600-55-4)
- 1-(2-Fluorophenyl)-3-(4-isobutylphenyl)-1H-pyrazole-5-carboxylic acid (CAS 618103-04-1)
- 1,2,2-Tris[(S)-4-isopropyl-4,5-dihydro-2-oxazolyl]propane (CAS 458563-75-2)
- 3-Hydroxyindazole-5-carboxylic Acid (CAS 787580-93-2)
- tert-Butyl 2-hydroxy-3-nitrobenzoate (CAS 889857-87-8)
- Semaglutide Impurity 138 (CAS CATO-C4X-2226138)
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