Desiodo Amiodarone HCl / Amiodarone Related Compound C
Beschreibung
Amiodaron EP-Verunreinigung C, auch als Amiodaron Related Compound C oder Desiodo-Amiodaron (freie Base) bezeichnet, ist das deiodierte Analogon des benzofuranischen Antiarrhythmikums. CAS 85642-08-6 gehört zu C25H30INO3 mit einer Molekülmasse von 519,13 und bewahrt die Aryloxyethanolamin- sowie Diethylaminoethoxy-Substituenten, verliert jedoch das für Amiodaron charakteristische Iodatom. Das Auftreten wird eher mit synthetischer Dehalogenierung oder oxidativer Biotransformation als mit Nitrosaminchemie in Verbindung gebracht. Für Charakterisierung und Spurenbestimmung sind LC-MS/MS, hochauflösende LC-MS und, sofern die Flüchtigkeit ausreicht, GC-MS üblich, da eng verwandte Positionisomere und Halogenanaloga die chromatographische Trennung erschweren.
References
Karmarkar, S., et al. “Quality by Design (QbD) Based Development and Validation of an HPLC Method for Amiodarone Hydrochloride and Its Impurities in the Drug Substance.â€Â Journal of Pharmaceutical and Biomedical Analysis, vol. 100, Nov. 2014, pp. 167–74, https://doi.org/10.1016/j.jpba.2014.07.002.
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