Empagliflozin Impurity 31 CAS 1806-23-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1806-23-1
Molecular FormulaC13H8ClFO
Molecular Weight234.65 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin Impurity 31 CAS 1806-23-1 chemical structure

Description

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.

As a process- or degradation-related impurity, Empagliflozin Impurity 31 (CAS 1806-23-1, C13H8ClFO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Empagliflozin Impurity 31 (C13H8ClFO) contains a hydroxyl group, an ether linkage, fluorine/chlorine substitution, an aromatic ring system. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

Physical & Chemical Properties

Molecular FormulaC13H8ClFO
Molecular Weight234.65 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
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
CAS Registry Year (est.)1957
Halogen ContentF/Cl-containing

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