Prednisolone Impurity 42 CAS 3597-59-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3597-59-9
Molecular FormulaC23H30O6
Molecular Weight402.48 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Prednisolone Impurity 42 CAS 3597-59-9 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.

CATO supplies Prednisolone Impurity 42 (CAS 3597-59-9), a pharmacopoeial impurity reference standard (molecular formula C23H30O6, MW 402.48 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, a hydroxyl group, an ether linkage, Prednisolone Impurity 42 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 402.48 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC23H30O6
Molecular Weight402.48 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958

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