H-Cys-Ser-Asn-Leu-Ser-Thr-Cys-Val-Leu-Gly-Lys-Leu-Ser-Glu-Glu-Leu-His-Lys-Leu-Gln-Thr-Tyr-Pro-Arg-Thr-Asn-Thr-Gly-Ser-Gly-Thr-Pro-NH2 (Disulfide bond between Cys1 and Cys7)
Pharmacopeial Synonyms
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Sinónimos
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Descripción
La impureza Glu-14-Calcitonin se caracteriza por la introducción de un residuo glutamato en la posición 14 del péptido calcitonina y requiere análisis riguroso para su identificación y cuantificación. Su perfil analítico se establece mediante cromatografía líquida de alta resolución (HPLC) acoplada a espectrometría de masas y mapeo peptídico, complementado con análisis de aminoácidos y espectroscopía para confirmar masa y secuencia. Esta impureza puede afectar la estabilidad, la actividad biológica y aumentar el riesgo de agregación o inmunogenicidad, por lo que se controlan límites de especificación, estrategias de purificación específicas y estudios de degradación forzados para garantizar calidad y conformidad regulatoria.
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