Epalrestat impurity 33 CAS 39486-57-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.39486-57-2
Molecular FormulaC5H6N2O2S2
Molecular Weight190.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Epalrestat impurity 33 CAS 39486-57-2 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.

Epalrestat impurity 33 (CAS 39486-57-2) is a certified pharmaceutical impurity reference standard with the molecular formula C5H6N2O2S2 and a molecular weight of 190.24 g/mol.

Structurally, Epalrestat impurity 33 (C5H6N2O2S2) contains an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 190.24 g/mol, it falls into the medium-molecular-weight range. 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.

Physical & Chemical Properties

Molecular FormulaC5H6N2O2S2
Molecular Weight190.24 g/mol
Purity97%+
StorageStore at 2-8°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)4.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1968
Nitrogen Atoms2
Sulfur Atoms2

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