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含量均匀度符合规定的制剂判断标准是
更新时间: 2021-03-19 06:12:24  

1、含量均匀度Contentuniformity是指小剂量口服固体制剂、粉雾剂或注射用无菌粉末中的每片(个)含量偏离标示量的程度。

2、另有规定外,片剂、胶囊或注射用无菌粉末每片(个)标示量小于10mg或主药含量小于每片个重量的5mg;其它制剂,每个标示量小于2mg或主药含量小于每个重量2者,均应检查含量均匀度。

关键词: 含量 均匀 符合 规定 制剂 判断 标准

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