Difluprednate Impurity 3 CAS 1234557-20-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1234557-20-0
Molecular FormulaC20H24F2O5
Molecular Weight382.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Difluprednate Impurity 3 CAS 1234557-20-0 chemical structure

Description

The occurrence of Difluprednate Impurity 3 is closely related to a flavonoid core, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Difluprednate Impurity 3 (CAS 1234557-20-0, C20H24F2O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Difluprednate Impurity 3 (C20H24F2O5) contains a flavonoid core, a hydroxyl group, an ether linkage, fluorine 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. 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 FormulaC20H24F2O5
Molecular Weight382.40 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Halogen ContentF-containing

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