Prednisolone Acetate EP Impurity E CAS 4380-55-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.4380-55-6
Molecular FormulaC23H28O5
Molecular Weight384.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Prednisolone Acetate EP Impurity E CAS 4380-55-6 chemical structure

Description

CATO supplies Prednisolone Acetate EP Impurity E (CAS 4380-55-6), a pharmacopoeial impurity reference standard (molecular formula C23H28O5, MW 384.47 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C23H28O5, Prednisolone Acetate EP Impurity E contains a flavonoid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 384.47 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC23H28O5
Molecular Weight384.47 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, 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
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958

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