Apremilast Impurity 31 CAS 1831833-38-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1831833-38-5
Molecular FormulaC12H16O4S
Molecular Weight256.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast Impurity 31 CAS 1831833-38-5 chemical structure

Description

The occurrence of Apremilast Impurity 31 is closely related to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Apremilast Impurity 31 (CAS 1831833-38-5, C12H16O4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Apremilast Impurity 31 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 256.32 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC12H16O4S
Molecular Weight256.32 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1995
Sulfur Atoms1

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