Fudosteine Impurity 52 CAS CATO-C4X-144752

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-144752
Molecular FormulaC10H17NO7S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fudosteine Impurity 52 CAS CATO-C4X-144752 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.

Fudosteine Impurity 52 (CAS CATO-C4X-144752) is a certified pharmaceutical impurity reference standard with the molecular formula C10H17NO7SHCl and a molecular weight of 331.76 g/mol.

Owing to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Fudosteine Impurity 52 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 331.76 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.

Physical & Chemical Properties

Molecular FormulaC10H17NO7S HCl
Molecular Weight331.76 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
Halogen ContentCl-containing
Nitrogen Atoms1
Sulfur Atoms1

Related Fudosteine Standards

Recommended Standards

Why CATO?