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新虫 (职业作家)

[求助] 加粗标记的话如何理解?

the characterization and quantitation of each impurity-related substance or degradation product present in the active substance or pharmaceutical formulation is regularly performed by hplc-uv analytical techniques. it is particularly important to determine the uv response factor of the impurity since it can be different from that of the active substance. in such cases it could happen that the active substance is declared to be pharmaceutically confirmed according to the requirements, although the levels of its impurities may be outside of the permitted values。

加粗的这句话如何理解?
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rohdy

新虫 (著名写手)

有些杂质的响应跟有效成分的不一样,所以采用有效成分的方法去测定杂质,会出现杂质看似没超标但实际超标的情况

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2楼2019-03-23 20:30:11
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