Berberine Impurity 1 (HCl Salt), CAS 430433-40-2, es una impureza relacionada estructuralmente con la berberina que se forma durante la síntesis y el almacenamiento, presentando la forma de sal de clorhidrato; posee solubilidad diferencial en disolventes orgánicos y acuosos y tendencia a formar sales con posible higroscopicidad, características que influyen en su cuantificación analítica. Su identificación y cuantificación se realizan por HPLC con detección UV y confirmación por LC-MS y RMN, empleando estándares de referencia y métodos validados. El seguimiento en estudios de estabilidad y en el perfil de impurezas es esencial para controlar la pureza del API, establecer límites aceptables y mitigar rutas de degradación.
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