N-Desmethyl Telmisartan (CAS 144701-81-5) es una impureza de desmetilación del telmisartán que requiere control riguroso en desarrollo y fabricación. Presenta cambios en polaridad y perfil cromatográfico que afectan la separación analítica; se detecta y cuantifica mediante HPLC-UV | LC-MS/MS e identificación por espectrometría de masas y RMN. Su formación puede deberse a reacciones de metabolismo químico o a condiciones de síntesis y estabilidad. Deben establecerse límites aceptables basados en datos toxicológicos | estudios de degradación forzada y ensayos de estabilidad | implementando procedimientos de control y estándares de referencia para garantizar la seguridad y conformidad regulatoria del medicamento.
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