Apremilast Impurity 59 CAS CATO-C4X-100959

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100959
Molecular FormulaC42H42N4O12S
Molecular Weight826.87 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast Impurity 59 CAS CATO-C4X-100959 chemical structure

Description

Structurally, Apremilast Impurity 59 (C42H42N4O12S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 24.0, corresponding to approximately 24 ring(s) or double-bond equivalent(s). With a molecular weight of 826.87 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a process- or degradation-related impurity, Apremilast Impurity 59 (CAS CATO-C4X-100959, C42H42N4O12S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 FormulaC42H42N4O12S
Molecular Weight826.87 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)24.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4
Sulfur Atoms1

Related Apremilast Standards

Recommended Standards

Why CATO?