3″-N-Demethyl-3′-N-formyl-6-O-methylerythromycin A ;
Synonyme
N-Demethyl-N-formyl Clarithromycin; Clarithromycin Impurity H
Beschreibung
Clarithromycin EP Impurity H, auch als N-Demethyl-N-formyl Clarithromycin oder Clarithromycin Impurity H bezeichnet, ist eine makrolidbezogene Prozess- und Abbauverunreinigung mit der CAS-Nummer 127140-69-6. Strukturell entsteht sie aus Clarithromycin durch N-Demethylierung gefolgt von N-Formylierung an der Aminofunktion des Desosaminrests, wodurch ein neutrales tertiäres Amid-Analogon vorliegt. Die Summenformel lautet C38H67NO14, das Molekulargewicht beträgt 761.94. Aufgrund der engen strukturellen Nähe zum Wirkstoff erfordert die Bestimmung typischerweise LC-MS/MS oder hochauflösende LC-MS, ergänzt durch HPLC-UV und NMR zur Peakzuordnung und zur Verunreinigungscharakterisierung in pharmakopöischen Untersuchungen.
References
Fraschini, Franco, et al. “Clarithromycin Clinical Pharmacokinetics.†Clinical Pharmacokinetics, vol. 25, no. 3, Sept. 1993, pp. 189–204, https://doi.org/10.2165/00003088-199325030-00003. ‌
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