ArticleEJNMMI radiopharmacy and chemistry2022
Radiolabeling and quality control of therapeutic radiopharmaceuticals: optimization, clinical implementation and comparison of radio-TLC/HPLC analysis, demonstrated by [
Article in EJNMMI radiopharmacy and chemistry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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Who cites it
20 citing papers in PubMed.
- Development and evaluation of improved in-house procedure for radiolabelling of theranostic agent [EJNMMI radiopharmacy and chemistry · 2026Article
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- Chemical Tools to Characterize the Coordination Chemistry of Radionuclides for Radiopharmaceutical Applications.Chemical reviews · 2025Review
- Stability assessment of PET radiopharmaceuticals under extreme conditions: an ICH-compliant study on radiochemical and enantiomeric purity.EJNMMI radiopharmacy and chemistry · 2025Article
- Tailored Reaction Conditions and Automated Radiolabeling of [International journal of molecular sciences · 2025Article
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- [EJNMMI radiopharmacy and chemistry · 2024Article
- Revolutionizing cancer treatment: The role of radiopharmaceuticals in modern cancer therapy.Precision radiation oncology · 2024Review
- Implementing Ac-225 labelled radiopharmaceuticals: practical considerations and (pre-)clinical perspectives.EJNMMI radiopharmacy and chemistry · 2024Review
- Aspects and prospects of preclinical theranostic radiopharmaceutical development.Theranostics · 2024Review
- Targeted Alpha Therapy: All We Need to Know aboutPharmaceuticals (Basel, Switzerland) · 2023Review
- Quality Assurance Investigations and Impurity Characterization during Upscaling of [Molecules (Basel, Switzerland) · 2023Article
- Recent Innovations and Nano-Delivery of Actinium-225: A Narrative Review.Pharmaceutics · 2023Review
- Review
- Optimization ofEJNMMI radiopharmacy and chemistry · 2023Article
- Improved quality control of [EJNMMI radiopharmacy and chemistry · 2023Article
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10 authors.
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Abstract
backgroundRadiopharmaceuticals are considered as regular medicinal products and therefore the same regulations as for non-radioactive medicinal products apply. However, specific aspects should be considered due to the radiochemical properties. Radiopharmaceutical dedicated monographs are developed in the European Pharmacopoeia to address this. Currently, different quality control methods for non-registered radiopharmaceuticals are utilized, often focusing on radio-TLC only, which has its limitations. When the radiochemical yield (RCY) is measured by radio-TLC analysis, degradation products caused by radiolysis are frequently not detected. In contrast, HPLC analysis defines the radiochemical purity (RCP), allowing for detection of peak formation related to radiolysis. During the introduction and optimization phase of therapeutic radiopharmaceuticals, significant percentages of impurities, like radiolysed construct formation, may have consequential impact on patient treatment. Since more hospitals and institutes are offering radiopharmaceutical therapies, such as [
resultsDownscaled conditions (74 MBq/μg) were in concordance to clinical conditions (18 GBq/250 µg, 5 mL syringe/100 mL flacon); all results were consistent with an > 98% RCY (radio-TLC) and stability of > 95% RCP (HPLC). Radio-TLC did not identify radiolysis peaks, while clear identification was performed by HPLC analysis. Decreasing the RCP with 50%, reduced the cell-binding capacity with 27%.
conclusionThis research underlines the importance of the radiolabeling and optimization including clinical implementation and clarifies the need for cross-validation of the RCY and RCP for quality control measurements. Only HPLC analysis is suitable for identification of radiolysis. Here we have proven that radiolysed [
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