Cholic Acid Impurity 28 CAS CATO-C4X-116028

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-116028
Molecular FormulaC28H36O2
Molecular Weight404.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cholic Acid Impurity 28 CAS CATO-C4X-116028 chemical structure

Description

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.

CATO supplies Cholic Acid Impurity 28 (CAS CATO-C4X-116028), a pharmacopoeial impurity reference standard (molecular formula C28H36O2, MW 404.58 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C28H36O2, Cholic Acid Impurity 28 contains a steroid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 404.58 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC28H36O2
Molecular Weight404.58 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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