Dapagliflozin Impurity 18 CAS 461432-22-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.461432-22-4
Molecular FormulaC15H12BrClO2
Molecular Weight339.61 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dapagliflozin Impurity 18 CAS 461432-22-4 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 18.

CATO supplies Dapagliflozin Impurity 18 (CAS 461432-22-4), a pharmacopoeial impurity reference standard (molecular formula C15H12BrClO2, MW 339.61 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine/bromine substitution, a polycyclic aromatic system, Dapagliflozin Impurity 18 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 339.61 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

CATO manufactures Dapagliflozin Impurity 18 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC15H12BrClO2
Molecular Weight339.61 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentCl/Br-containing

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