Der Ampicillin-Hydantoin-Analog ist eine semisynthetische, beta-Lactam-bezogene Verunreinigung mit der Formel C17H17N3O5S und einer Molekülmasse von 375,4 g/mol. Strukturell handelt es sich um ein ringtransformiertes Abbauprodukt von Ampicillin, das plausibel durch intramolekulare Umlagerung oder hydrolytische Reaktionswege mit anschließender Hydantoinbildung aus dem Penicillin-Grundgerüst entsteht. Sein Nachweis ist für Stabilitätsuntersuchungen relevant, da solche Transformationsprodukte unter sauren, thermischen oder oxidativen Bedingungen auftreten können. Die Identifizierung erfordert üblicherweise LC-MS/MS zur Bestätigung des Molekülions sowie LC-HRMS und NMR zur Strukturelucidierung. Die regulatorische Bewertung sollte die Verunreinigungsqualifizierung nach pharmakopöischen und ICH-Grundsätzen berücksichtigen.
References
Swami, Onkar C. “Ampicillin: Rise Fall & Resurgence.” JOURNAL of CLINICAL and DIAGNOSTIC RESEARCH, 2014, www.ncbi.nlm.nih.gov/pmc/articles/PMC4080027/, 10.7860/jcdr/2014/8777.4356.
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