Fudosteine Impurity 10 CAS CATO-C4X-144710

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-144710
Molecular FormulaC9H19NO4S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fudosteine Impurity 10 CAS CATO-C4X-144710 chemical structure

Description

CATO supplies Fudosteine Impurity 10 (CAS CATO-C4X-144710), a pharmacopoeial impurity reference standard (molecular formula C9H19NO4SHCl, MW 273.77 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Fudosteine Impurity 10 (C9H19NO4SHCl) contains an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 0.0, corresponding to approximately 0 ring(s) or double-bond equivalent(s). With a molecular weight of 273.77 g/mol, it falls into the medium-molecular-weight range. 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.

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 FormulaC9H19NO4S HCl
Molecular Weight273.77 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
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)0.0
Halogen ContentCl-containing
Nitrogen Atoms1
Sulfur Atoms1

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