Glyceryl Guaiacolate Metabolite (CAS 13057-65-3) | también conocido como metabolito de guaifenesina o ácido propanoico 2-hidroxi-3-(2-metoxifenoxi) | es una impureza relevante por su estructura funcional que incluye un grupo carboxílico y sustituyentes fenoxi metoxi. Desde el punto de vista analítico | requiere monitorización mediante HPLC con detección por UV y confirmación por LC-MS y RMN para identificación y cuantificación precisas. Su presencia indica vías de degradación o biotransformación y puede afectar la estabilidad y el perfil de seguridad del principio activo. Se recomienda establecer límites de especificación | estudios de degradación forzada y métodos validados para asegurar control y cumplimiento regulatorio.
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