Apremilast Impurity 75 CAS CATO-C4X-100975

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100975
Molecular FormulaC21H22N2O7S
Molecular Weight446.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast Impurity 75 CAS CATO-C4X-100975 chemical structure

Description

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.

Apremilast Impurity 75 (CAS CATO-C4X-100975) is a certified pharmaceutical impurity reference standard with the molecular formula C21H22N2O7S and a molecular weight of 446.47 g/mol.

Based on its molecular formula C21H22N2O7S, Apremilast Impurity 75 contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 446.47 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

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 FormulaC21H22N2O7S
Molecular Weight446.47 g/mol
Purity>95%
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2
Sulfur Atoms1

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