S-Carboximetilcisteína (CAS 638-23-3) | también registrada como S-Carboxymethyl-L-cysteine | L-(Carboxymethyl)cysteine y L-3-((Carboxymethyl)thio)alanine | es una impureza sulfurada que puede formarse por carboximetilación del residuo de cisteína durante la síntesis o el almacenamiento. Presenta solubilidad en agua y una masa molecular definida que facilita su identificación por HPLC con detección UV y confirmación por LC-MS y NMR. Su presencia compromete la pureza y el perfil de seguridad del principio activo debido a su reactividad con grupos amino y tiólicos. Se recomienda establecer límites según ICH Q3A/Q3B | validar métodos de cuantificación y controlar condiciones de reacción y pH para minimizar su formación.
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