Impureza de metanolato de abacavir (Abacavir Methanolate Impurity) é um subproduto da síntese do API formado por reação com metanol ou transesterificação durante etapas de parada da reação ou de processamento. Caracteriza-se por massa molecular modificada e polaridade alterada | detectável e quantificável por HPLC com detecção UV | LC-MS e GC-MS para voláteis | além de confirmação estrutural por RMN. A presença desta impureza pode comprometer pureza | estabilidade e perfil toxicológico do lote | exigindo monitoramento em processo | limites especificados e estratégias de remoção como lavagem orgânica | recristalização e cromatografia para garantir conformidade regulatória.
Referências
“Abacavir: MedlinePlus Drug Information.†Medlineplus.gov, Jan. 2022, medlineplus.gov/druginfo/meds/a699012.html.
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