Apremilast Impurity 54 CAS CATO-C4X-100954

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100954
Molecular FormulaC20H21NO6S
Molecular Weight403.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast Impurity 54 CAS CATO-C4X-100954 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 54.

Apremilast Impurity 54 (CAS CATO-C4X-100954) is a certified pharmaceutical impurity reference standard with the molecular formula C20H21NO6S and a molecular weight of 403.45 g/mol.

Based on its molecular formula C20H21NO6S, Apremilast Impurity 54 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 403.45 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 manufactures Apremilast Impurity 54 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC20H21NO6S
Molecular Weight403.45 g/mol
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1
Sulfur Atoms1

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