Apremilast impurity 15 CAS 1384441-38-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1384441-38-6
Molecular FormulaC21H22N2O7S
Molecular Weight446.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast impurity 15 CAS 1384441-38-6 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 15.

CATO supplies Apremilast impurity 15 (CAS 1384441-38-6), a pharmacopoeial impurity reference standard (molecular formula C21H22N2O7S, MW 446.47 g/mol) used for the identification and quantification of trace impurities in APIs.

Apremilast impurity 15 (C21H22N2O7S) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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).

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 15 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 FormulaC21H22N2O7S
Molecular Weight446.47 g/mol
Purity>95%
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.)1991
Nitrogen Atoms2
Sulfur Atoms1

Related Apremilast Standards

Recommended Standards

Why CATO?