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.
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:
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.