Impureza Androstandionic (CAS 85234-64-6) é um subproduto identificado durante o controle de qualidade de matérias-primas esteroides; apresenta perfil analítico distinto com pontos de fusão e espectros de massa característicos que exigem monitoramento rigoroso. A presença desta impureza pode afetar pureza | estabilidade e segurança do lote | justificando quantificação por HPLC com detecção UV ou LC-MS para confirmação estrutural. Limites de especificação devem ser estabelecidos conforme guidelines ICH e farmacopéias pertinentes | incluindo validação de método para precisão | linearidade e limite de detecção. Procedimentos de amostragem e relatórios de lote garantem rastreabilidade e conformidade regulatória.
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