Empagliflozin Impurity 42 CAS CATO-C4X-106542

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106542
Molecular FormulaC17H16ClIO3
Molecular Weight430.66 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin Impurity 42 CAS CATO-C4X-106542 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 42.

CATO supplies Empagliflozin Impurity 42 (CAS CATO-C4X-106542), a pharmacopoeial impurity reference standard (molecular formula C17H16ClIO3, MW 430.66 g/mol) used for the identification and quantification of trace impurities in APIs.

Empagliflozin Impurity 42 (C17H16ClIO3) contains a steroid core, a hydroxyl group, an ether linkage, chlorine/iodine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 Empagliflozin Impurity 42 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 FormulaC17H16ClIO3
Molecular Weight430.66 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
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
Halogen ContentCl/I-containing

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