Amlodipino Impureza 24 (CAS 34148-67-9) es un subproducto específico identificado durante la síntesis y degradación del amlodipino que requiere control analítico riguroso. Presenta propiedades fisicoquímicas distinguibles y se caracteriza por técnicas como HPLC | LC-MS y RMN para garantizar la correcta identificación y cuantificación en el perfil de impurezas. Su presencia puede afectar pureza y estabilidad del lote si no se controla mediante optimización de condiciones de reacción y purificación. Información técnica incluye límites de especificación | metodologías de muestreo | criterios de aceptación y estrategias de eliminación para cumplir requisitos regulatorios y de garantía de calidad en desarrollo y producción farmacéutica.
Referencias
Fares, Hassan, et al. Amlodipine in Hypertension: A First-Line Agent with Efficacy for Improving Blood Pressure and Patient Outcomes.” Open Heart, vol. 3, no. 2, Sept. 2016, p. e000473, https://doi.org/10.1136/openhrt-2016-000473.
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