中药有害残留物分析中质量控制指导原则

Guideline for quality control in analysis of harmful residues in traditional Chinese medicines

本文论述了依照法定标准进行中药有害残留物检测时,方法确认、方法偏离和日常检测分析质量控制应遵循的主要技术要求。指导不同实验室在中药有害残留物检测分析中,从残留水平、分析方法专属性与灵敏度、风险水平等因素综合考量,确保分析结果的准确度满足风险评估要求。

This paper discusses the main technical requirements for the method validation,method deviation and routine detection of harmful residues in traditional Chinese medicine(TCM) according to legal standards.It will guide different laboratories to consider the residual level,specificity and sensitivity,risk level and other factors in the analysis of harmful residues of TCM,to ensure that the accuracy of the results meets the requirements of risk assessment.