药典分析方法确认指标的确定  

Verification of characteristics of analytical-method

作　　者：杨芝博 YANG Zhi-bo(College of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016

出　　处：《中南药学》2023年第1期208-211,共4页Central South Pharmacy

摘　　要：目的对药典分析方法确认的指标进行评估。方法结合国内外相关技术文件的指导意见,总结并分析药典分析方法确认的指标选择,并对其合理性进行评估。结果分别从药典“通用检测方法”“鉴别检查法”“低浓度定量/限度检查法”和“高浓度定量/限度检查法”四个方面对不同类型检查法的确认指标进行了归纳、总结与论述,确定了药典分析方法确认的指标。结论明确了药典分析方法确认指标的选择依据,为制药行业的分析方法确认工作提供参考及借鉴。Objective To verify the characteristic indexes of analytical method.Methods We summarized and analyzed the characteristic indexes of analytical method based on domestic and foreign documents,and assessed their rationalization.Results We analyzed the indexes of different analytical methods from“general procedures”“identification procedures”“quantitative/limit test at a low concentration”and“quantitative/limit test at a high concentration”,and verified the characteristics of the analytical methods.Conclusion The selection of characteristic indexes of analytical methods verified,providing reference for the verification of analytical methods in pharmaceutical industry.

关 键 词：药品 分析方法 确认指标 药典 

分 类 号：R95[医药卫生—药学]