Pemafibrate Impurity 53 CAS CATO-C4X-290353

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-290353
Molecular FormulaC9H15F3O5S
Molecular Weight292.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pemafibrate Impurity 53 CAS CATO-C4X-290353 chemical structure

Description

Pemafibrate Impurity 53 (CAS CATO-C4X-290353) is a certified pharmaceutical impurity reference standard with the molecular formula C9H15F3O5S and a molecular weight of 292.27 g/mol.

Owing to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, Pemafibrate Impurity 53 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 292.27 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 53 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 FormulaC9H15F3O5S
Molecular Weight292.27 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)1.0
Halogen ContentF-containing
Sulfur Atoms1

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