Lamotrigine EP Impurity E CAS 50-45-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.50-45-3
Molecular FormulaC7H4Cl2O2
Molecular Weight191.01 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lamotrigine EP Impurity E CAS 50-45-3 chemical structure

Description

The molecular framework of Lamotrigine EP Impurity E (C7H4Cl2O2) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).

CATO supplies Lamotrigine EP Impurity E (CAS 50-45-3), a pharmacopoeial impurity reference standard (molecular formula C7H4Cl2O2, MW 191.01 g/mol) used for the identification and quantification of trace impurities in APIs.

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 FormulaC7H4Cl2O2
Molecular Weight191.01 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentCl-containing

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