bulk drug substance 和formulated bulk
发布于 2014-02-19 · 浏览 1.1 万 · IP 上海上海
这个帖子发布于 11 年零 91 天前，其中的信息可能已发生改变或有所发展。
21CFR207中指出
Bulk drug substance means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.
问题
1、我原本以为bulk drug substance就是原液，但是后面又有finished dosage form，有点疑惑，究竟bulk drug substance指什么呢？
2、又看到另外一个词formulated bulk，我的理解是加了辅料待灌装的原液，不知道是否正确
请明白人指点指点~
Bulk drug substance means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.
问题
1、我原本以为bulk drug substance就是原液，但是后面又有finished dosage form，有点疑惑，究竟bulk drug substance指什么呢？
2、又看到另外一个词formulated bulk，我的理解是加了辅料待灌装的原液，不知道是否正确
请明白人指点指点~
最后编辑于 2022-10-09 · 浏览 1.1 万
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