Valaciclovir Related Compound E; N-Benzyloxycarbonyl Valacyclovir; (2-[(2-Amino-6-oxo-1, 6-dihydro-9H-purin-9-yl)-methoxy]ethyl N-[(Benzyloxy)carbonyl]-L-valinate; Valacyclovir Related Compound E; Valaciclovir EP Impurity E; Valaciclovir USP Related Compound E
Descrição
Valaciclovir EP Impurity E (CAS 124832-31-1) | também conhecida como N-Benzyloxycarbonyl Valacyclovir ou Valacyclovir Related Compound E | é uma impureza processual observada no perfil de impurezas do valaciclovir. Sua presença indica reações de proteção carbamato durante a síntese e pode ser monitorada por HPLC com detectores UV e confirmada por espectrometria de massas e RMN. Para fins de controle de qualidade e conformidade a diretrizes ICH Q3A | limites de especificação e estratégias de limpeza de processo devem ser definidos. Métodos analíticos robustos e estudos de degradação forense permitem quantificar e reduzir esse produto relacionado | assegurando a pureza do API.
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