Quality control of radiopharmaceuticals and diagnostic nuclear medicine equipment

Edam, A.N.; Sulieman, Abdelmoneim; Sam, A.K.; Salih, Isam; Alkhorayef, M.; Bradley, D.A.

doi:10.1016/j.radphyschem.2019.03.051

Cited by 8 publications

(2 citation statements)

References 7 publications

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“…Once produced, the radioisotopes are tagged onto certain molecules based on biological characteristics, which results in radiopharmaceuticals [ 26 , 27 ]. Because of the risks involved, it is important to know the exact amount of radiopharmaceutical to be intake as it can lead to inaccurate diagnostic results and suboptimal therapeutic outcomes [ 28 , 29 ]. In a routine procedure at a nuclear medicine facility, the Well Type Ionization Chamber is commonly used to measure the concentration of a radiopharmaceutical [ 30 , 31 ].…”

Section: Introductionmentioning

confidence: 99%

Data reconciliation connected to guard bands to set specification limits related to risk assessment for radiopharmaceutical activity

Pereira,

Carvalheira,

Lopes

et al. 2023

Heliyon

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Section: Introductionmentioning

confidence: 99%

Data reconciliation connected to guard bands to set specification limits related to risk assessment for radiopharmaceutical activity

Pereira,

Carvalheira,

Lopes

et al. 2023

Heliyon

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“…In determining the accuracy of [ 153 Sm]Sm-EDTMP for targeted organs, it is necessary regarding the quality control of this radiopharmaceutical [8,9]. Quality control parameters in radiopharmaceutical preparations are generally almost the same as other sterile preparations such as visual observation, pH measurement, radionuclide purity, radiochemical purity, radioactive concentration and sterility testing using endotoxin bacterial testing [10].…”

Section: Introductionmentioning

confidence: 99%

The Use of Low Ammonia Concentration in the Radiochemical Purity Test of [153Sm]Sm-EDTMP by Using the Thin Layer Chromatography Method

Putra

Asyikin

Hendarto

et al. 2021

J. Pure App. Chem Res

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Radiochemical purity testing of [153Sm]Sm-EDTMP usually uses the Thin Layer Chromatography method. The mobile phase used is a mixture of 25% ammonia and water. However, the lowest ratio of 25% ammonia in the mobile phase is unknown. Therefore, research related to the use of the lowest concentration in the radiochemical purity test of [153Sm]Sm-EDTMP is necessary. This research method includes labelling of EDTMP using Samarium-153, preparation of the mobile phase with variations in the concentration of 25% ammonia: water, radiochemical purity test and data analysis using t-test statistics. The results of this study are the concentration of 25% ammonia: water (1: 9) to (1: 200) still shows good separation with Rf of [153Sm]SmCl3 and [153Sm]Sm-EDTMP at 0.0, 1.0 respectively, whereas with a thinner concentration of ammonia indicates less optimal separation with Rf [153Sm]SmCl3 at 0.35 to 1.0. Comparison of concentrated ammonia concentrations of 1: 9 and dilute 1: 200 was performed using a statistical t-test. The results of the data analysis showed that the two methods were not significantly different, indicated by the t-value of 0.82 less than 2.78. The conclusion of this study is that the lowest concentration of 25% ammonia and water in the radiochemical purity test of [153Sm]Sm-EDTMP is 1: 200.

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Effective radiation doses in pediatric PET/CT examinations: Pilot study

Alkhorayef

2021

Applied Radiation and Isotopes

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Quality control of radiopharmaceuticals and diagnostic nuclear medicine equipment

Cited by 8 publications

References 7 publications

Data reconciliation connected to guard bands to set specification limits related to risk assessment for radiopharmaceutical activity

Data reconciliation connected to guard bands to set specification limits related to risk assessment for radiopharmaceutical activity

The Use of Low Ammonia Concentration in the Radiochemical Purity Test of [153Sm]Sm-EDTMP by Using the Thin Layer Chromatography Method

Effective radiation doses in pediatric PET/CT examinations: Pilot study

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