Apremilast impurity 96 CAS 856806-92-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.856806-92-3
Molecular FormulaC9H9NO4
Molecular Weight195.17 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Apremilast impurity 96 CAS 856806-92-3 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 195.17 g/mol gives Apremilast impurity 96 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Apremilast impurity 96 (CAS 856806-92-3), a pharmacopoeial impurity reference standard (molecular formula C9H9NO4, MW 195.17 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Apremilast impurity 96 (C9H9NO4) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 195.17 g/mol, it falls into the medium-molecular-weight range. 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.

As a certified reference material (CRM), Apremilast impurity 96 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 FormulaC9H9NO4
Molecular Weight195.17 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987
Nitrogen Atoms1

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