| CAS No. | 53343-18-3 |
| Molecular Formula | C12H15F3O2 |
| Molecular Weight | 248.24 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 248.24 g/mol gives Memantine Impurity 43 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Memantine Impurity 43 (CAS 53343-18-3), a pharmacopoeial impurity reference standard (molecular formula C12H15F3O2, MW 248.24 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Memantine Impurity 43 (C12H15F3O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 248.24 g/mol, it falls into the medium-molecular-weight range. 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.
As a certified reference material (CRM), Memantine Impurity 43 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | C12H15F3O2 |
| Molecular Weight | 248.24 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1972 |
| Halogen Content | F-containing |