Telmisartan Impurity 8 (CAS 114772-34-8) es un derivado aromático identificado como éster metílico de 4′-metilbifenilo-2-carboxílico | también conocido por sinónimos como Methyl 2-(p-Tolyl)benzoate y Methyl 4′-Methylbiphenyl-2-carboxylate; esta impureza surge por reacciones secundarias de esterificación o transposición durante la síntesis y purificación y puede comprometer la pureza y perfil de calidad del lote. Presenta baja polaridad y elevada lipofilicidad | lo que requiere técnicas analíticas específicas como GC-MS | HPLC-UV y RMN para su detección y cuantificación. Su control exige métodos validados | límites especificados y medidas de mitigación en proceso para cumplimiento regulatorio.
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