Indapamide USP Related Compound B; 5-(5-oxido-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)pentanoic acid
Descripción
Impureza C de Indapamida EP (sal de HCl) | CAS 31529-47-2 | también referida como Indapamide USP Related Compound B y 5-(5-oxido-2-oxohexahidro-1H-thieno[3 | 4-d]imidazol-4-yl)pentanoic acid | es un degradante significativo observado durante la síntesis y el almacenamiento de indapamida; su presencia requiere identificación y cuantificación precisas. Se describe mediante espectroscopía RMN | espectrometría de masas y perfiles de HPLC/LC-MS validados | con parámetros de retención y fragmentación específicos. El control analítico incluye límites de aceptación basados en monografías EP y USP | además de estudios de estabilidad | solubilidad y pureza para asegurar conformidad regulatoria y minimizar riesgos de calidad en el producto farmacéutico final.
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