Epirubicin EP Impurity B CAS 21794-55-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.21794-55-8
Molecular FormulaC21H18O8
Molecular Weight398.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Epirubicin EP Impurity B CAS 21794-55-8 chemical structure

Description

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.

As a process- or degradation-related impurity, Epirubicin EP Impurity B (CAS 21794-55-8, C21H18O8) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Epirubicin EP Impurity B (C21H18O8) contains a flavonoid core, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

Physical & Chemical Properties

Molecular FormulaC21H18O8
Molecular Weight398.36 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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1963

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