3″-N-Demethyl-3′-N-formyl-6-O-methylerythromycin A ;
Sinónimos
N-Demethyl-N-formyl Clarithromycin; Clarithromycin Impurity H
Descripción
La Impureza H de Claritromicina EP, también denominada N-Demetil-N-formil Claritromicina o Claritromicina Impureza H, es una impureza de proceso y degradación relacionada con los macrólidos, con CAS 127140-69-6. Estructuralmente deriva de la claritromicina por N-demetilación seguida de N-formilación en la función amino de la desosamina, originando un análogo de amida terciaria neutra. Su fórmula molecular es C38H67NO14 y su peso molecular es 761.94. Debido a su estrecha similitud con el antibiótico progenitor, su determinación suele requerir LC-MS/MS o LC-MS de alta resolución, complementadas con HPLC-UV y RMN para asignación de picos y perfilado de impurezas en estudios farmacopeicos.
Referencias
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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