CHROMATOGRAPHICP EAKS 色谱峰
13.1. Chromatographic analysis should meet ALCOA+ principles.
色谱分析应符合ALCOA+原则。
13.2. Factors considered during method validation should include
方法验证中考虑的因素应包括：
• recovery experiments;
• 回收率实验
• slope sensitivity;
• 斜率灵敏度
• peak width;
• 峰宽
• bunching factor;
• 集束因子
• area reject;
• 最小峰面积（忽略阈值）
• noise threshold; and
• 噪声阈值
• area threshold.
• 峰面积阈值
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.
应根据原则和程序，包括国家药监机构、药典和分析验证的建议和要求对峰的可接受度进行检查。
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.
如果在复杂的色谱分析中使用了不止一支色谱柱，其程序和指令应清楚以确保在分析中不会出错。
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+.
程序应包括本指南中所述的优良色谱规范建议和考量，以及对原则、可接受标准（适当时）和ALCOA+的具体参考。
