Ursodeoxycholic Acid Impurity 118 CAS 83896-19-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.83896-19-9
Molecular FormulaC23H38N2O5
Molecular Weight422.56 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ursodeoxycholic Acid Impurity 118 CAS 83896-19-9 chemical structure

Description

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.

Ursodeoxycholic Acid Impurity 118 (CAS 83896-19-9) is a certified pharmaceutical impurity reference standard with the molecular formula C23H38N2O5 and a molecular weight of 422.56 g/mol.

Structurally, Ursodeoxycholic Acid Impurity 118 (C23H38N2O5) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 422.56 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

Physical & Chemical Properties

Molecular FormulaC23H38N2O5
Molecular Weight422.56 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1980
Nitrogen Atoms2

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