Impureza Sorafenib Related compound 13 (CAS 845306-04-9) | conocida también como 6-Chloro-N-methylpicolinamide | es una impureza de proceso relevante en la síntesis de sorafenib que requiere control riguroso por su impacto en el perfil de calidad. Su identificación y cuantificación se realiza mediante HPLC con detección UV y confirmación por LC-MS y RMN para asegurar asignación estructural. Los criterios analíticos incluyen límites de especificación basados en ICH Q3A | estudios de estabilidad y evaluación de riesgos relacionados con degradación y biotransformación. Ofrecemos material de referencia y soporte técnico para trazabilidad | validación de métodos y reducción de niveles residuales en lotes de producción.
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