Dexamethasone Impurity 104 CAS 62800-49-1

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.62800-49-1
Molecular FormulaC22H27FO4
Molecular Weight374.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dexamethasone Impurity 104 CAS 62800-49-1 chemical structure

Description

CATO supplies Dexamethasone Impurity 104 (CAS 62800-49-1), a pharmacopoeial impurity reference standard (molecular formula C22H27FO4, MW 374.45 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Dexamethasone Impurity 104 (C22H27FO4) is characterized by a flavonoid core, a hydroxyl group, an ether linkage, fluorine 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 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC22H27FO4
Molecular Weight374.45 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at 2-8°C, 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
CAS Registry Year (est.)1974
Halogen ContentF-containing

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