恩格列净杂质68 CAS 2452301-13-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2452301-13-0
Molecular FormulaC17H16BrIO2
Molecular Weight459.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

恩格列净杂质68 CAS 2452301-13-0 chemical structure

Description

CATO supplies 恩格列净杂质68 (CAS 2452301-13-0), a pharmacopoeial impurity reference standard (molecular formula C17H16BrIO2, MW 459.12 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of 恩格列净杂质68 (C17H16BrIO2) is characterized by a steroid core, a hydroxyl group, an ether linkage, bromine/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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

As a certified reference material (CRM), 恩格列净杂质68 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.

Physical & Chemical Properties

Molecular FormulaC17H16BrIO2
Molecular Weight459.12 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
CAS Registry Year (est.)2000
Halogen ContentBr/I-containing

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