Pemafibrate Impurity 28 CAS CATO-C4X-290328

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-290328
Molecular FormulaC12H17NO3
Molecular Weight223.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pemafibrate Impurity 28 CAS CATO-C4X-290328 chemical structure

Description

The occurrence of Pemafibrate Impurity 28 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Pemafibrate Impurity 28 (CAS CATO-C4X-290328) is a certified pharmaceutical impurity reference standard with the molecular formula C12H17NO3 and a molecular weight of 223.27 g/mol.

Structurally, Pemafibrate Impurity 28 (C12H17NO3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 223.27 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Pemafibrate Impurity 28 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 FormulaC12H17NO3
Molecular Weight223.27 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

Related Pemafibrate Standards

Recommended Standards

Why CATO?