S-Carboximetilcisteína (CAS 638-23-3) | também conhecida por S-Carboxymethyl-L-cysteine e L-(carboxymethyl)cysteine | é uma impureza tiol carboxilada que surge por carboximetilação do grupo tiol da cisteína. Quimicamente polar e em forma zwitteriônica | apresenta boa solubilidade aquosa e tendência a oxidar formando dissulfetos | o que influencia estabilidade e perfil de degradação de lotes. A sua identificação e quantificação são realizadas por HPLC com detecção UV ou LC-MS e confirmadas por RMN. Controle analítico em processo e especificação de limite são recomendados | assim como estudos de estabilidade e reatividade para mitigar riscos de qualidade e questões regulatórias.
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