Prednisolone Impurity 35 CAS CATO-C4X-173735

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-173735
Molecular FormulaC23H27BrO7
Molecular Weight495.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Prednisolone Impurity 35 CAS CATO-C4X-173735 chemical structure

Description

The occurrence of Prednisolone Impurity 35 is closely related to a flavonoid core, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Prednisolone Impurity 35 (CAS CATO-C4X-173735, C23H27BrO7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Prednisolone Impurity 35 (C23H27BrO7) contains a flavonoid core, a hydroxyl group, an ether linkage, bromine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC23H27BrO7
Molecular Weight495.36 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing

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