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Study to Define Frequency in Routine Analytical Controls in the Radiolabelling Process


Inthe radiolabelling process, the frequency of routine analytical testing must bedefined with a risk assessment based on different factors (Pharmeuropa Vol. 26No. 2, 5.19). Aim of this study is to define the criteria based on the riskassessment required for setting the frequency of analytical controls. 331 preparationsof three different radiopharmaceuticals labeled with ,Tc wereexamined analyzing temporal trends o,f radiochemical purity values, potentialcorrelation between radiochemical purity values and total radioactivity contentof bulk as well as potential correlation between radiochemical purity valuesand radioactivity concentration of bulk. The analysis shows no directcorrelation between percentage of radiochemical purity and total radioactivitycontent of preparation and between radiochemical purity values andradioactivity concentration in final bulk solution. Moreover, the routineanalytical controls executed for one year on each preparation made it possibleto determine how the an......

【作者名称】: F. Ria, G. Albini, S. Battista, V. Salvatore, R. Messere, A. Bergantin
【关 键 词】: Analytical Controls, Radiolabelling Process, Frequency, Risk Assessment, Open Access Library
【网站名称】: OALIB数据库
【期刊论文数据库】: [DBS_Articles_01]
【期刊论文编号】: 103,633,805
【摘要长度】: 1,000
【栏目名称】: 所有文件
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