Empagliflozin impurity 24 CAS CATO-C4X-1065324

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1065324
Molecular FormulaC46H52Cl2O14
Molecular Weight899.80 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin impurity 24 CAS CATO-C4X-1065324 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 24.

Empagliflozin impurity 24 (CAS CATO-C4X-1065324) is a certified pharmaceutical impurity reference standard with the molecular formula C46H52Cl2O14 and a molecular weight of 899.80 g/mol.

Structurally, Empagliflozin impurity 24 (C46H52Cl2O14) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 20.0, corresponding to approximately 20 ring(s) or double-bond equivalent(s). With a molecular weight of 899.80 g/mol, it falls into the high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC46H52Cl2O14
Molecular Weight899.80 g/mol
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
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)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing

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