Empagliflozin impurity 253 CAS 395-11-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.395-11-9
Molecular FormulaC13H8FIO
Molecular Weight326.10 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin impurity 253 CAS 395-11-9 chemical structure

Description

As a process- or degradation-related impurity, Empagliflozin impurity 253 (CAS 395-11-9, C13H8FIO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Empagliflozin impurity 253 (C13H8FIO) contains a hydroxyl group, an ether linkage, fluorine/iodine 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Empagliflozin impurity 253 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 FormulaC13H8FIO
Molecular Weight326.10 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
CAS Registry Year (est.)1957
Halogen ContentF/I-containing

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