Vanheusden V, De Braekeleer K, Corthout J
APB, Service de Contrôle des Médicaments, Bruxelles.
J Pharm Belg. 2012 Mar(1):22-7.
Preparations formulated as coated or film-coated tablets, containing levonorgestrel and the combination ethinylestradiol/levonorgestrel, were evaluated in a comparative study. This study comprised in vitro dissolution, assay and content uniformity. The analytical methods were previously validated according to international guidelines. All examined products complied with the postulated requirements.
对含有左炔诺孕酮以及乙炔雌二醇/左炔诺孕酮组合的包衣片或薄膜包衣片制剂进行了一项对比研究评估。该研究包括体外溶出度、含量测定和含量均匀度。分析方法先前已根据国际指南进行验证。所有检测产品均符合假定要求。