Validation of an alternative radiochemical purity method for [99mTc]pentetate ([99mTc]DTPA)

Borré, María Candela; Tesan, Fiorella Carla; Leonardi, Natalia M.; Zubillaga, Marcela; Salgueiro, M.

doi:10.1016/j.apradiso.2013.09.007

Cited by 2 publications

(3 citation statements)

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“…Radiochemical purity (RCP) is an important quality parameter for radiopharmaceuticals, as their radiochemical form determines their biodistribution. 14,17 For this reason, the use of radiopharmaceutical in vivo needs RCP testing to be carried out just before administration to the patient. 16,18,19 To determine radiochemical purity labeling efficiency of the product, European Pharmacopeia's chromatographic method, which is fast and easy, has been used.…”

Section: Radiochemical Puritymentioning

confidence: 99%

“…16,18,19 To determine radiochemical purity labeling efficiency of the product, European Pharmacopeia's chromatographic method, which is fast and easy, has been used. 14 This method involves ascending instant thin layer chromatography (ITLC). The ITLC strips were utilized as the stationary phase and two different solvent systems as indexed in European Pharmacopeia 2008.…”

Section: Radiochemical Puritymentioning

confidence: 99%

“…99m Tc-DTPA is the most commonly used radiopharmaceutical for renography. 14 The commercial DTPA kits are usually made of pentasodium or calcium trisodium salt of DTPA (diethylene triamine penta acetate. The freeze-dry kitcontains appropriate amounts of stannous chloride dehydrate in lyophilized form.…”

Section: Introductionmentioning

confidence: 99%

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Development and biodistrubition modeling of 99mTc-DTPA

Bricha

Hamzaoui

Benhamou

et al. 2015

Int J Cancer Ther Oncol

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In this study, the team modeled the biodistribution and the efficiency of two 99m -technetium diethylene triamine penta acetate ( 99m Tc-DTPA) based radiopharmaceuticals. Methods: The first radiopharmaceutical (DTPA-CNESTEN) is developed at the laboratories of the radiopharmaceutical production unit of the National Center for Nuclear Energy, Sciences and Technologies (CNESTEN-Morocco), and the second one is the commercial DTPA (DTPA-ref). Freeze-dried kits were successfully radiolabeled (radiochemical purity >95%) with the 99m Tc. Then drugs were injected to male BALB/c mice. In each 2 min, 5 min, 15 min, 1 h and 2 h time points after injections we evaluate tissue's distributions characteristics. At the end, an automatic modeling of the data were recorded from thyroid, blood and urinary excretion kinetics and biodistribution in mice using both DTPA kits. The study aimed to extract the parameters of the function used to fit the recorded data. Results and Conclusion: the team concluded that the biodistribution of 99m Tc-DTPA can be modeled using a combination of two exponential parts. Moreover, the resultant plots showed that there is strong correlation between the formula found in literature and the one derived on the basis of the fit of data sets in this study. In addition, it was found that the biodistribution behaviors of the developed kit and the commercial one were very close. The obtained results suggest that the developed DTPA has practically the same kinetics as the commercial one.

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Section: Radiochemical Puritymentioning

confidence: 99%

Section: Radiochemical Puritymentioning

confidence: 99%

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Development and biodistrubition modeling of 99mTc-DTPA

Bricha

Hamzaoui

Benhamou

et al. 2015

Int J Cancer Ther Oncol

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Validation of [^99mTc]Tc-DTPA radiochemical testing method using one-system paper chromatography

Putra

Lestary

Maskur

et al. 2020

J. Phys.: Conf. Ser.

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Kidney failure is a degenerative disease that has a prevalence of nearly 12 to 15% of the total population in the world. Renal scans are one of many diagnostic means which refers to several examinations using radiopharmaceuticals that evaluate the function and anatomy of the kidneys. Technetium-99m-diethylenetriaminepetaacetic acid ([99Tc]Tc-DTPA) is a commonly used radiopharmaceutical for kidney scans. Since the half-life of technetium-99m radioisotope, one component of this radiopharmaceutical, is only about 6.0 hours, so an efficient and effective quality control techniques is a necessity. Up to now, two-systems thin layer chromatography (TLC) is a common method used for radiochemical purity (RCP) test of [99mTc]Tc-DTPA. Recently one-system TLC has been successfully developed for this purpose. Therefore prior to its application, it is necessary to validate as well to compare this method with an established method (WHO Pharmacopoeia). These methods were two-system used Whatman-1 paper as static phase and methyl ethyl ketone (two-system-A) and 0.9% sodium chloride (two-system-B) as mobile phases and one-system used Whatman-1 paper as static phase and acetone: 0.9% sodium chloride (11:9) as a mobile phase. RCP of [99mTc]Tc-DTPA was then tested using these methods. The retrieved data were processed and validated with some variables like accuracy, precision, and compared using t-test to see whether the above-mentioned TLC systems show a significant difference or not. The analysis results of RCP test of [99mTc]Tc-DTPA using two-system method was 99.37± 0.48% while using one-system method was 99.20 ± 0.41%. The percentage accuracy of the data between two methods was 99.83%. The t-stat value for both methods was 0.84 so it can be concluded that the results of measurement using one-system method are not significantly different from two-system method.

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Validation of an alternative radiochemical purity method for [99mTc]pentetate ([99mTc]DTPA)

Cited by 2 publications

References 9 publications

Development and biodistrubition modeling of 99mTc-DTPA

Development and biodistrubition modeling of 99mTc-DTPA

Validation of [^99mTc]Tc-DTPA radiochemical testing method using one-system paper chromatography

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Validation of an alternative radiochemical purity method for [99mTc]pentetate ([99mTc]DTPA)

Cited by 2 publications

References 9 publications

Development and biodistrubition modeling of 99mTc-DTPA

Development and biodistrubition modeling of 99mTc-DTPA

Validation of [99mTc]Tc-DTPA radiochemical testing method using one-system paper chromatography

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Validation of [^99mTc]Tc-DTPA radiochemical testing method using one-system paper chromatography