Discussion on evaluation mode of proficiency testing for heavy metal and harmful element detection in medicines.
10.19540/j.cnki.cjcmm.20190118.003
- Author:
Yao-Lei LI
1
;
Hong-Yu JIN
1
;
Xin-Hua XIANG
1
;
Shuang-Cheng MA
1
Author Information
1. National Institutes for Food and Drug Control Beijing 100050,China.
- Publication Type:Journal Article
- Keywords:
Horwitz function;
NIQR;
algorithm A;
deviation;
empirical model;
heavy metals and harmful elements;
proficiency testing;
robust statistical method
- MeSH:
Cadmium;
analysis;
Laboratories;
Laboratory Proficiency Testing;
Lonicera;
chemistry;
Pharmaceutical Preparations;
standards;
Plant Preparations;
standards;
Trace Elements;
analysis
- From:
China Journal of Chinese Materia Medica
2019;44(8):1724-1728
- CountryChina
- Language:Chinese
-
Abstract:
This study aims to explore the evaluation model for the proficiency testing of heavy metal and harmful element residues in pharmaceuticals,and to provide reference for the proficiency testing program and proficiency testing result in the field of residue analysis. The proficiency test result of cadmium determination in honeysuckle as an example. The algorithm A,NIQR,and Horwitz function are used to calculate the assigned value and the standard deviation. Z was obtained at the same time. If | Z | ≤2,the result is satisfactory. If 2< | Z | <3,the result is questionable. If | Z | ≥3,the result is unsatisfactory. In addition,the median value is the assigned value,and deviation(D%) is used. If D% is not more than 16%,the result is satisfactory; if D% is more than 16%,the result is unsatisfactory. After analysis,in the results of questionable or dissatisfied laboratories calculated by algorithm A and NIQR,the deviation error of some data is within the scope of the standard. In the results of the satisfactory laboratory evaluated by the Horwitz function,some data deviation errors far exceed the standard range. The evaluation result of the D% meets the requirements. According to heavy metal and harmful element trace analysis methods,this study is the first to apply D% to the evaluation of the detection ability of heavy metals and harmful elements in pharmaceuticals. This method makes the evaluation result more reasonable,and has important reference significance for the evaluation of other proficiency test results.
