Apremilast Impurity 113 CAS CATO-C4X-1009113

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1009113
Molecular FormulaC12H18O4S
Molecular Weight258.33 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast Impurity 113 CAS CATO-C4X-1009113 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Apremilast Impurity 113.

As a process- or degradation-related impurity, Apremilast Impurity 113 (CAS CATO-C4X-1009113, C12H18O4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Apremilast Impurity 113 (C12H18O4S) contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC12H18O4S
Molecular Weight258.33 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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Sulfur Atoms1

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