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Thioctic Acid EP Impurity B

● Under Development

Catalogue No.:	VE0020337
CAS No.:	N/A
Mol. Formula:	H2O[C8H14OS2]n
Mol. Weight:	18.02[190.33]n

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Additional information on Thioctic Acid EP Impurity B

Parent drug

Thioctic Acid

IUPAC Name

Alpha-hydro-omega-hydroxypoly[sulfanediyl(3-sulfanyl-8-oxooctane-1,8-diyl)] (mixture of thioctic acid polymers)

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Description

Thioctic Acid EP Impurity B corresponds to a hydrated oligomeric sulfur-containing species related to lipoic acid degradation and/or process-derived polymerization, represented by the empirical notation H2O[C8H14OS2]n and an associated repeating-unit mass of 190.33 n, with terminal water contribution of 18.02. The material is best considered a family of higher oligomers rather than a discrete single compound. Its formation is consistent with oxidative, thermal, or sulfur-mediated coupling pathways during manufacture or storage. Characterization typically requires LC-MS/MS, high-resolution LC-MS, and, where volatility permits, GC-MS, together with chromatographic resolution against monomeric thioctic acid and related sulfur impurities.