Dexamethasone Sodium Phosphate EP Impurity H CAS 162968-22-1

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.162968-22-1
Molecular FormulaC22H32FO8P
Molecular Weight474.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dexamethasone Sodium Phosphate EP Impurity H CAS 162968-22-1 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 474.46 g/mol gives Dexamethasone Sodium Phosphate EP Impurity H distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Dexamethasone Sodium Phosphate EP Impurity H (CAS 162968-22-1) is a certified pharmaceutical impurity reference standard with the molecular formula C22H32FO8P and a molecular weight of 474.46 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 Sodium Phosphate EP Impurity H is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 474.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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 FormulaC22H32FO8P
Molecular Weight474.46 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>90%
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
CAS Registry Year (est.)2003
Halogen ContentF-containing

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