Dapagliflozin Impurity 56 CAS CATO-C4X-113856

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-113856
Molecular FormulaC15H34O6Si3
Molecular Weight394.68 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dapagliflozin Impurity 56 CAS CATO-C4X-113856 chemical structure

Description

As a process- or degradation-related impurity, Dapagliflozin Impurity 56 (CAS CATO-C4X-113856, C15H34O6Si3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Dapagliflozin Impurity 56 (C15H34O6Si3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development.

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 FormulaC15H34O6Si3
Molecular Weight394.68 g/mol
Purity>95%
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)-1.0

Related Dapagliflozin Standards

Recommended Standards

Why CATO?