Dapagliflozin Impurity 104 CAS CATO-C4X-1138104

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1138104
Molecular FormulaC12H26O6Si2
Molecular Weight322.50 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dapagliflozin Impurity 104 CAS CATO-C4X-1138104 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 Dapagliflozin Impurity 104.

Dapagliflozin Impurity 104 (CAS CATO-C4X-1138104) is a certified pharmaceutical impurity reference standard with the molecular formula C12H26O6Si2 and a molecular weight of 322.50 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, Dapagliflozin Impurity 104 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 322.50 g/mol — guide the selection of appropriate sample preparation and analytical techniques.

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 FormulaC12H26O6Si2
Molecular Weight322.50 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)0.0

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