Thiamine Impurity 58 CAS CATO-C4X-187358

Description

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.

CATO supplies Thiamine Impurity 58 (CAS CATO-C4X-187358), a pharmacopoeial impurity reference standard (molecular formula C13H19N4OSHClCl, MW 351.29 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C13H19N4OSHClCl, Thiamine Impurity 58 contains a nitrogen-containing heterocyclic scaffold, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 351.29 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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

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