Obeticholic Acid Impurity 48 CAS CATO-C4X-115348

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-115348
Molecular FormulaC32H58O4Si
Molecular Weight534.89 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Obeticholic Acid Impurity 48 CAS CATO-C4X-115348 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Obeticholic Acid Impurity 48.

As a process- or degradation-related impurity, Obeticholic Acid Impurity 48 (CAS CATO-C4X-115348, C32H58O4Si) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Obeticholic Acid Impurity 48 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 534.89 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC32H58O4Si
Molecular Weight534.89 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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