Impureza de pirazol de Eltrombopague (Eltrombopag Pyrazole Impurity) | CAS 277299-70-4 | conhecida também como 2-(3 | 4-dimetilfenil)-5-metil-1H-pirazol-3(2H)-ona (sinônimos: 2-(3 | 4-dimethylphenyl)-5-methyl-1H-pyrazol-3-one; 1-(3 | 4-dimethylphenyl)-3-methyl-5-pyrazolone) | é um subproduto sintético relevante no processo de fabricação do ativo. Caracteriza-se por núcleo pirazolona substituído | exigindo identificação e quantificação precisas por HPLC | LC-MS e RMN para avaliação de pureza e perfil de impurezas. A presença desta impureza pode afetar especificações do API e deve ser monitorada e controlada conforme diretrizes ICH referentes a impurezas | com limites e procedimentos analíticos definidos para garantir conformidade e qualidade do produto final.
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