Empagliflozin Impurity 45 CAS CATO-C4X-106545

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106545
Molecular FormulaC13H7ClFIO
Molecular Weight360.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin Impurity 45 CAS CATO-C4X-106545 chemical structure

Description

As a certified reference material (CRM), Empagliflozin Impurity 45 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.

CATO supplies Empagliflozin Impurity 45 (CAS CATO-C4X-106545), a pharmacopoeial impurity reference standard (molecular formula C13H7ClFIO, MW 360.55 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Empagliflozin Impurity 45 (C13H7ClFIO) contains a hydroxyl group, an ether linkage, fluorine/chlorine/iodine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 360.55 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC13H7ClFIO
Molecular Weight360.55 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl/I-containing

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