Amoxicillin Related Compound 1 (HCl Salt) | CAS 127369-30-6 | es una impureza relacionada que aparece en formulaciones y procesos de síntesis de amoxicilina HCl. Presenta relevancia analítica por su posible impacto en la estabilidad y pureza del principio activo. Su identificación y cuantificación se realiza habitualmente mediante HPLC con detección UV y confirmación por LC-MS y RMN para caracterizar perfiles de degradación. El control de proceso y las condiciones de almacenamiento minimizan su formación; los límites se establecen conforme a guías regulatorias ICH para impurezas específicas. Documentación de lotes y estudios de degradación respaldan la gestión de riesgo y cumplimiento de calidad.
Referencias
Akhavan, Bobak J, and Praveen Vijhani. “Amoxicillin.†Nih.gov, StatPearls Publishing, 7 Mar. 2019, www.ncbi.nlm.nih.gov/books/NBK482250/.
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