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杂质峰 已有1人参与
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HPLC色谱图上峰面积是4的小峰要不要当成杂峰看？可以不把它当成峰吗？ 发自小木虫IOS客户端 |
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| 在USP<621>中对最后一段中对杂质的取舍进行了规定，原文如下：When the impurity test prescribes the total of impurities or there is a quantitative determination of an impurity, choice of an appropriate threshold setting and appropriate conditions for the integration of the peak areas is important. In such tests the limit at or below which a peak is disregarded is generally 0.05%. Thus, the threshold setting of the data collection system corresponds to at least half of this limit. Integrate the peak area of any impurity that is not completely separated from the principal peak, preferably by valley-to-valley extrapolation (tangential skim). |
2楼2019-09-25 09:51:08