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星星點炮新蟲 (職業(yè)作家)
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[求助]
加粗標(biāo)記的話如何理解?
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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。 加粗的這句話如何理解? |

新蟲 (著名寫手)
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有些雜質(zhì)的響應(yīng)跟有效成分的不一樣,所以采用有效成分的方法去測定雜質(zhì),會出現(xiàn)雜質(zhì)看似沒超標(biāo)但實際超標(biāo)的情況 發(fā)自小木蟲Android客戶端 |
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