La impureza EP G de amlodipino, también denominada Amlodipine Related Compound C, es una impureza de proceso estructuralmente definida asociada con el bloqueante de canales de calcio dihidropiridínico amlodipino. Con CAS 43067-01-2, fórmula molecular C17H18ClNO4 y peso molecular de 335,78 g/mol, corresponde a un derivado de piridina clorada compatible con arrastre de intermedios de síntesis o formación de subproductos durante la construcción del heterociclo y las etapas de esterificación. Su determinación suele requerir LC-MS/MS para perfiles a nivel traza, con HPLC-UV para resolución cromatográfica y ensayo de impurezas. No es una nitrosamina, pero sigue siendo pertinente para la calificación de impurezas conforme a criterios farmacopeicos e ICH.
Referencias
Ananchenko, Gennady, et al. Amlodipine Besylate.†Profiles of Drug Substances, Excipients and Related Methodology, 2012, pp. 31–77, https://doi.org/10.1016/b978-0-12-397220-0.00002-7.?
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