Apremilast Impurity 38 CAS 2095036-40-9

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.2095036-40-9
Molecular FormulaC20H20N2O8S
Molecular Weight448.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast Impurity 38 CAS 2095036-40-9 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.

CATO supplies Apremilast Impurity 38 (CAS 2095036-40-9), a pharmacopoeial impurity reference standard (molecular formula C20H20N2O8S, MW 448.45 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Apremilast Impurity 38 (C20H20N2O8S) is characterized by a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC20H20N2O8S
Molecular Weight448.45 g/mol
Purity>90%
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
CAS Registry Year (est.)1997
Nitrogen Atoms2
Sulfur Atoms1

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