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    發布時間:2019-10-29 16:21 原文鏈接: PEAKINTEGRATION峰積分

    14.1. Peak areas  in  analytical chromatograms  should  be accurately  and  consistently integrated in a scientifically sound manner.

    分析色譜中的峰面積積分應準確一致、科學合理。


    14.2. Where possible, HPLC and GC instruments should be interfaced with computerised chromatographic data capturing and processing systems which are capable of performing the integration process automatically.

    如果可能,HPLC和GC儀器應與能自動進行積分處理的計算機化色譜數據采集和處理系統設置接口。


    14.3. The same integration parameters shouldbe applied to all peaks in a sample set or sample sequence unless otherwise scientifically justifiable.

    除另有科學論證外,同一樣品序列或樣品序列中的所有峰均應使用相同的積分參數。


    14.4. Personnel should select appropriate values for the parameters (such as, slope sensitivity, noise threshold, peak width, area threshold and bunching factor and skim ratio) which are used by the processing software to define the respective chromatographic peaks.

    應選擇適當的參數值(如斜率靈敏度、噪聲閾值、峰寬、峰面積閾值和集束因子及撇去比率)在處理軟件中定義相應的色譜峰。


    14.5. To facilitate the accurate integration of chromatographic peaks, it is necessary that all of the peaks are fully separated. If quantitative data must be obtained from unseparated peaks, the laboratory should have clear policies as to how such peaks should be integrated. This should include a description as to when it is acceptable to use different functions for integrating unresolved peaks, such as:

    為便于對色譜峰進行準確積分,有必要將所有峰完全分離。如果必須從未分開的峰中獲得定量數據,則實驗室應制訂明確的方針說明如何對這些峰進行積分。其中應包括闡明何時可使用不同函數對未分離的峰進行積分,如:

    ?       tangential skim;

    ?       切線撇去

    ?       exponential skim;

    ?       指數撇去

    ?       exponential curve fitting;

    ?       指數曲線設置

    ?       straight line skim;

    ?       直線撇去

    ?       front peak skim;

    ?       前伸峰撇去

    ?       rear peak skim;

    ?       拖尾峰撇去

    ?       peak valley ratio; and

    ?       峰谷比

    ?       valley height ratio.

    ?       峰高比


    14.6. Validated methods, specified chromatographic conditions and good chromatography practices should facilitate obtaining symmetrical peaks. Where fronting, tailing, split peaks or other types of peaks are observed, these should be investigated, the root cause identified and appropriate CAPA taken.

    經過驗證的方法、具體的色譜條件和優良色譜規范有助于獲得對稱峰。如果發現有前伸峰、拖尾峰、分裂峰或其它類型的峰,應進行調查,找出根本原因并采取適當的CAPA。

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