Pemafibrate Impurity 15 CAS CATO-C4X-290315

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-290315
Molecular FormulaC28H32N2O4
Molecular Weight460.56 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pemafibrate Impurity 15 CAS CATO-C4X-290315 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 460.56 g/mol gives Pemafibrate Impurity 15 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Pemafibrate Impurity 15 (CAS CATO-C4X-290315), a pharmacopoeial impurity reference standard (molecular formula C28H32N2O4, MW 460.56 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C28H32N2O4, Pemafibrate Impurity 15 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 460.56 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.

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 FormulaC28H32N2O4
Molecular Weight460.56 g/mol
AppearancePale yellow to yellow crystalline powder
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)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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