Memantine Impurity 43 CAS 53343-18-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.53343-18-3
Molecular FormulaC12H15F3O2
Molecular Weight248.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Memantine Impurity 43 CAS 53343-18-3 chemical structure

Description

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.

Physical & Chemical Properties

Molecular FormulaC12H15F3O2
Molecular Weight248.24 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972
Halogen ContentF-containing

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