Cholic Acid Impurity 85 CAS CATO-C4X-116085

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-116085
Molecular FormulaC49H76O9
Molecular Weight809.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cholic Acid Impurity 85 CAS CATO-C4X-116085 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.

As a process- or degradation-related impurity, Cholic Acid Impurity 85 (CAS CATO-C4X-116085, C49H76O9) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Cholic Acid Impurity 85 (C49H76O9) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 809.12 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC49H76O9
Molecular Weight809.12 g/mol
Purity≥95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

Related Cholic Standards

Recommended Standards

Why CATO?