Empagliflozin impurity 246 CAS CATO-C4X-1065246

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1065246
Molecular FormulaC14H9ClFIO
Molecular Weight374.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin impurity 246 CAS CATO-C4X-1065246 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Empagliflozin impurity 246.

As a process- or degradation-related impurity, Empagliflozin impurity 246 (CAS CATO-C4X-1065246, C14H9ClFIO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Empagliflozin impurity 246 (C14H9ClFIO) contains a hydroxyl group, an ether linkage, fluorine/chlorine/iodine substitution, a polycyclic aromatic 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. 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.

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 FormulaC14H9ClFIO
Molecular Weight374.58 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/I-containing

Related Empagliflozin Standards

Recommended Standards

Why CATO?