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法规和指南
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BPOG
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USP
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化药相容性(中国)
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目的
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研究工艺流体和接触部件的相互作用
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研究的参数
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时间
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压力
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温度
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提取物
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差的溶液条件(有代表性、标准的)
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浸出物
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根据提取物情况,实际工艺条件下进行,组件的提取物最终是会汇总到成品中的,每增加1个组件,提取物就会增多。
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生产组件
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高风险
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膜包
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介质
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滤芯
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# 放置方法
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原理:要跟所有不同材质充分接触
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正置:跟底部材质,一般为玻璃,卡式瓶为活塞
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倒置:接触顶部,一般为胶塞
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侧置:都接触到
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水剂产品中,含气量多少可能会影响产品的稳定性
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