Apremilast impurity 89 CAS CATO-C4X-100989

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100989
Molecular FormulaC20H24N2O7S
Molecular Weight436.48 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast impurity 89 CAS CATO-C4X-100989 chemical structure

Description

CATO supplies Apremilast impurity 89 (CAS CATO-C4X-100989), a pharmacopoeial impurity reference standard (molecular formula C20H24N2O7S, MW 436.48 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Apremilast impurity 89 (C20H24N2O7S) 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), Apremilast impurity 89 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC20H24N2O7S
Molecular Weight436.48 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2
Sulfur Atoms1

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