Effect of 99Tc on the radiochemical purity of 99mTc radiopharmaceuticals

Waight, Lynn A; Cunnane, Caroline M.; O’Brien, Lesley M.; Millar, A. M.

doi:10.1097/mnm.0b013e32834755df

Cited by 5 publications

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…After 30 days, the RCP was tested upon which it was discovered that the aliquots were effectively maintained with an average RCP of 98.56% for fractions maintained between −20 and −28°C in nonoxygenated vials and 97.15% for fractions maintained between 0 and +4°C. 22 Successful biodistribution studies localized in the region of interest were seen in the human subjects.…”

Section: Discussionmentioning

confidence: 99%

Exploring the Use of Ambientally Stored Methylene Diphosphonate Radiopharmaceutical Aliquots in Solving Challenging Situations in Developing Countries

Zulu,

Katebe,

Ramli

et al. 2024

World J Nucl Med

View full text Add to dashboard Cite

Objectives The primary aim was to evaluate the prolonged quality characteristics of methyl diphosphonate (MDP) aliquots during ambient storage over a specified duration. This study further investigated potential additives that could enhance the stability of MDP aliquots stored under such conditions. Materials and Methods This was a laboratory-based experimental study conducted at the University Teaching Adult Hospital in Lusaka, Zambia. A total of 36 MDP aliquots stored at ambient conditions and 4 MDP aliquots stored at conventional refrigerated frozen conditions were labeled with technitium-99m (99mTc) and tested for radiochemical purity (RCP) and other quality characteristics. A comparative analysis of the stability and quality of MDP aliquots from the two cohorts was then conducted. Statistical Analysis Stata 14 was used to analyze the data on the RCP of all MDP aliquots. Results The RCP of ambient stored MDP aliquots was found to be ranging from 98 to 99%, while that for frozen and refrigerated ones ranged from 99 to 100%. There was also a 1% increase in RCP for both cohorts with argon gas purging (98 and 99%, respectively). Conclusion The RCP of MDP aliquots from both cohorts was much higher than the required minimum of 90% implying that there was no significant association of their stability and quality with the mode of storage. However, purging with argon gas seemed to increase the stability further in both streams. The study findings show potential for application in resource-constrained environments and centers, especially in developing countries, where challenges to maintain the cold storage chain of these important radiopharmaceuticals are likely to be encountered due to power outages.

show abstract

Section: Discussionmentioning

confidence: 99%

Exploring the Use of Ambientally Stored Methylene Diphosphonate Radiopharmaceutical Aliquots in Solving Challenging Situations in Developing Countries

Zulu,

Katebe,

Ramli

et al. 2024

World J Nucl Med

View full text Add to dashboard Cite

show abstract

“…Another study found slightly lower labeling with Monday pertechnetate, but the effect was only significant for MAA. 28 It is also recognized that the efficiency with in vivo red blood cell labeling is poorer on a Monday. 29 The same has been reported for the modified in vivo method.…”

Section: Generalmentioning

confidence: 99%

Pitfalls and Limitations of SPECT, PET, and Therapeutic Radiopharmaceuticals

Ballinger

2015

Seminars in Nuclear Medicine

View full text Add to dashboard Cite

“…This effect can cause an undesired uptake of [ 99m Tc]TcO 4 − into the thyroid, but also into the salivary and gastric tissues, compromising image quality and delivering an unjustified radiation dose to the patient (Hingorani et al 2010 ). The efficacy of radiolabelling of the nanocolloidal HSA depends on the size distribution of the particles, however, any excipients such as buffers, inorganic ions, or large amount of glucose present within the kit, as well as the quality of the generator eluate may all play a role in the speciation of 99m Tc (Persico et al 2015 ; Metaye et al 2012 ; Waight et al 2011 ).…”

Section: Introductionmentioning

confidence: 99%

An investigation of aspects of radiochemical purity of 99mTc-labelled human serum albumin nanocolloid

Cusnir

Leresche

Pilloud

et al. 2021

EJNMMI radiopharm. chem.

View full text Add to dashboard Cite

Background Nanocolloidal human serum albumin radiolabelled with 99mTc provides a diagnostic radiopharmaceutical for sentinel node lymphoscintigraphy. NanoHSA (Nanotop), a commercially available kit, enables the simple preparation of this radiopharmaceutical via reconstitution with pertechnetate eluted from a generator. Thin-layer chromatography is widely used for determining radiochemical purity in clinical nuclear medicine. Quality control methods recommended by the manufacturer were sometimes reported to yield variable results. Therefore, we proposed and evaluated three alternative thin-layer chromatography methods for the quality control of [99mTc]Tc-NanoHSA from a commercially available kit. Results The radiochemical purity of [99mTc]Tc-NanoHSA determined with all methods was reproducible and met the requirements of the SPC and the European Pharmacopoeia (≥ 95%). Our quality control using iTLC-SG chromatographic paper in methyl ethyl ketone mobile phase identified only free pertechnetate as impurity, resulting in > 99% RCP. The quality control using iTLC-SG in 85% methanol or iTLC-SA in 0.9% NaCl identified an additional small fraction of a hydrophilic impurity, resulting in 95–97% RCP. Glucose was identified as a potential 99mTc-carrying hydrophilic species contributing to hydrophilic impurities. Conclusion Our quality control of [99mTc]Tc-NanoHSA with non-polar mobile phase tended to underestimate the amount of hydrophilic impurities, although without compromising the final quality of the radiopharmaceutical. Alternative TLC methods using aqueous mobile phases enabled a more accurate determination of hydrophilic impurities.

show abstract

Effect of 99Tc on the radiochemical purity of 99mTc radiopharmaceuticals

Abstract: Seven of the eight radiopharmaceuticals tested can safely be prepared using eluate from a generator that has remained uneluted for 7 days. Under these conditions, care must be taken when preparing Tc-macrosalb, as its RCP remains unsatisfactory up to 2 h after preparation.

Cited by 5 publications

References 0 publications

Exploring the Use of Ambientally Stored Methylene Diphosphonate Radiopharmaceutical Aliquots in Solving Challenging Situations in Developing Countries

Exploring the Use of Ambientally Stored Methylene Diphosphonate Radiopharmaceutical Aliquots in Solving Challenging Situations in Developing Countries

Pitfalls and Limitations of SPECT, PET, and Therapeutic Radiopharmaceuticals

An investigation of aspects of radiochemical purity of 99mTc-labelled human serum albumin nanocolloid

Contact Info

Product

Resources

About