Empagliflozin impurity 214 CAS 2819995-58-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2819995-58-7
Molecular FormulaC20H25ClO2Si
Molecular Weight360.95 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin impurity 214 CAS 2819995-58-7 chemical structure

Description

The molecular framework of Empagliflozin impurity 214 (C20H25ClO2Si) is characterized by a steroid core, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

Empagliflozin impurity 214 (CAS 2819995-58-7) is a certified pharmaceutical impurity reference standard with the molecular formula C20H25ClO2Si and a molecular weight of 360.95 g/mol.

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 FormulaC20H25ClO2Si
Molecular Weight360.95 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2003
Halogen ContentCl-containing

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