Empagliflozin impurity 225 CAS CATO-C4X-1065225

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1065225
Molecular FormulaC13H7BrClFO
Molecular Weight313.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin impurity 225 CAS CATO-C4X-1065225 chemical structure

Description

The occurrence of Empagliflozin impurity 225 is closely related to a hydroxyl group, an ether linkage, fluorine/chlorine/bromine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Empagliflozin impurity 225 (CAS CATO-C4X-1065225) is a certified pharmaceutical impurity reference standard with the molecular formula C13H7BrClFO and a molecular weight of 313.55 g/mol.

Owing to a hydroxyl group, an ether linkage, fluorine/chlorine/bromine substitution, an aromatic ring system, Empagliflozin impurity 225 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 313.55 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC13H7BrClFO
Molecular Weight313.55 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl/Br-containing

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