Fudosteine Impurity 33 CAS CATO-C4X-144733

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-144733
Molecular FormulaC12H24N2O5S2
Molecular Weight340.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fudosteine Impurity 33 CAS CATO-C4X-144733 chemical structure

Description

As a process- or degradation-related impurity, Fudosteine Impurity 33 (CAS CATO-C4X-144733, C12H24N2O5S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Fudosteine Impurity 33 (C12H24N2O5S2) contains an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 340.46 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.

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 FormulaC12H24N2O5S2
Molecular Weight340.46 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
Nitrogen Atoms2
Sulfur Atoms2

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