N-Demethyl Rifampicin (CAS 13292-45-0) | también conocido por sinónimos como N-Desmethyl Rifampicin | N-Demethylrifampicin y N-Demethylrifampin | es una impureza crítica asociada a la degradación y a vías de N-desmetilación durante la síntesis de rifampicina. Su monitoreo en el perfil de impurezas es esencial para garantizar la integridad del lote y el cumplimiento regulatorio. Se caracteriza por técnicas analíticas de alta resolución como HPLC con detección UV | LC-MS y RMN para definir retención | masa molecular y estructura. Los métodos de control analítico y los límites de especificación deben establecerse en función del riesgo y la estabilidad para minimizar impacto en calidad del producto final.
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