13.1. Chromatographic analysis should meet ALCOA+ principles.
色譜分析應符合ALCOA+原則。
13.2. Factors considered during method validation should include
方法驗證中考慮的因素應包括：
? recovery experiments;
? 回收率實驗
? slope sensitivity;
? 斜率靈敏度
? peak width;
? 峰寬
? bunching factor;
? 集束因子
? area reject;
? 最小峰面積（忽略閾值）
? noise threshold; and
? 噪聲閾值
? area threshold.
? 峰面積閾值
13.3. Peaks should be reviewed for acceptability according to policies and procedures, including recommendations and requirements from national regulatory authorities, pharmacopoeia and analytical validation.
應根據原則和程序，包括國家藥監機構、藥典和分析驗證的建議和要求對峰的可接受度進行檢查。
13.4. Where more than one column has to be used in complex analysis, the procedure and instructions should be clear in order to ensure that no errors are made during analysis.
如果在復雜的色譜分析中使用了不止一支色譜柱，其程序和指令應清楚以確保在分析中不會出錯。
13.5. Procedures should include the recommendations and considerations for good chromatography practices as described in this guideline, with specific reference to policies, acceptance limits (as appropriate) and ALCOA+.
程序應包括本指南中所述的優良色譜規范建議和考量，以及對原則、可接受標準（適當時）和ALCOA+的具體參考。