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
, Risk Assessment
, Open Access Library
【上篇论文】: 外军国防科技报告 - Impact of Different Methods of Soil Sampling and DNA Extraction on the Identification of Soil Bacterial Abundance under Elevated CO2
【下篇论文】: 外军国防科技报告 - Left Ventricular Outflow Tract Obstruction after Ross-Konno Operation
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