La impureza Amidotrizoate EP Impurity A (CAS 1713-07-1) es un contaminante identificado en la síntesis y purificación del amidotrizoato conforme a la Farmacopea Europea. Se caracteriza por su perfil cromatográfico y espectrométrico y se monitoriza mediante HPLC-UV | LC-MS y RMN para confirmación estructural y cuantificación. Su presencia puede indicar rutas de degradación o subproductos de síntesis; por tanto se establecen especificaciones y límites de aceptabilidad en control de calidad y evaluación de estabilidad. Información sobre solubilidad | reactividad y comportamiento en condiciones de almacenamiento es crucial para mitigar su formación y garantizar la conformidad del lote.
Referencias
Ward, Dakota B., et al. “Radiocontrast Agent Diatrizoic Acid Induces Mitophagy and Oxidative Stress via Calcium Dysregulation.†International Journal of Molecular Sciences, vol. 20, no. 17, 21 Aug. 2019, p. 4074, www.ncbi.nlm.nih.gov/pmc/articles/PMC6747199/, 10.3390/ijms20174074. Accessed 31 Jan. 2022.
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