Dexamethasone Impurity 55 CAS CATO-C4X-116555

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-116555
Molecular FormulaC22H32FO7P
Molecular Weight458.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dexamethasone Impurity 55 CAS CATO-C4X-116555 chemical structure

Description

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.

Dexamethasone Impurity 55 (CAS CATO-C4X-116555) is a certified pharmaceutical impurity reference standard with the molecular formula C22H32FO7P and a molecular weight of 458.46 g/mol.

Owing to a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system, Dexamethasone Impurity 55 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 458.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC22H32FO7P
Molecular Weight458.46 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
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)6.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing

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