Loratadine 4-Hydroxymethyl Impurity (CAS 609806-40-8) | también conocida como 4-Hydroxymethyl Loratadine | es una impureza relacionada estructuralmente con la loratadina que surge por reacciones de hidroximetilación o degradación oxidativa del núcleo piperidínico. Su control es crítico en desarrollo y liberación de lotes por su impacto en pureza y estabilidad del principio activo. La caracterización analítica se realiza mediante HPLC con detección UV | LC-MS para confirmación de masa y RMN para elucidación estructural. Estudios de estrés forzado y perfiles de degradación permiten establecer límites de especificación y condiciones de almacenamiento que minimicen su formación durante la síntesis y conservación.
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