Epirubicin EP Impurity G (Epirubicin Dimer) CAS 1046827-43-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1046827-43-3
Molecular FormulaC54H58N2O22
Molecular Weight1087.04 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Epirubicin EP Impurity G (Epirubicin Dimer) CAS 1046827-43-3 chemical structure

Description

Epirubicin EP Impurity G (Epirubicin Dimer) (CAS 1046827-43-3) is a certified pharmaceutical impurity reference standard with the molecular formula C54H58N2O22 and a molecular weight of 1087.04 g/mol.

Epirubicin EP Impurity G (Epirubicin Dimer) (C54H58N2O22) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC54H58N2O22
Molecular Weight1087.04 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)27.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Nitrogen Atoms2

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