Empagliflozin Impurity 291 CAS CATO-C4X-1065291

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1065291
Molecular FormulaC18H18ClIO2
Molecular Weight428.69 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin Impurity 291 CAS CATO-C4X-1065291 chemical structure

Description

As a certified reference material (CRM), Empagliflozin Impurity 291 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

As a process- or degradation-related impurity, Empagliflozin Impurity 291 (CAS CATO-C4X-1065291, C18H18ClIO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Empagliflozin Impurity 291 (C18H18ClIO2) is characterized by a steroid core, a hydroxyl group, an ether linkage, chlorine/iodine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

Physical & Chemical Properties

Molecular FormulaC18H18ClIO2
Molecular Weight428.69 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, 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
Halogen ContentCl/I-containing

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