Alpha-Liponsäure-Impurity D, identifiziert als β-Liponsäure, CAS 6992-30-9, ist ein Positionsisomer der Thioctsäure und entsteht typischerweise durch stereochemische oder prozessbedingte Isomerisierung während Synthese, Isolierung oder Lagerung. Diese schwefelhaltige cyclische Disulfidverunreinigung besitzt die Summenformel C8H14O3S2 und eine Molmasse von 222,3 g/mol. Da ihr physikochemisches Verhalten dem des Wirkstoffs sehr ähnelt, erfordert die Trennung häufig chirale oder hochauflösende RP-LC mit orthogonaler LC-MS/MS-Bestätigung. Im regulatorischen Verunreinigungsprofil wird sie als strukturverwandte organische Verunreinigung und nicht als genotoxische Spezies bewertet, wobei NMR und Massenspektrometrie die Identitätszuordnung stützen.
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