AI Article Synopsis
- Lu-radiopharmaceuticals can have different levels of the impurity [Lu]lutetium, which poses challenges for waste disposal and sterility testing due to its long half-life of 160.4 days.
- An analysis of various Lu-samples confirmed that the Lu-concentration matched what was reported by suppliers and met European Pharmacopoeia standards.
- However, compliance with national radioactivity regulations, especially in Germany, poses issues, as some samples could not be transported for sterility testing and waste water management must be monitored for Lu-concentration to ensure safety.
Article Abstract
Background: Lu-radiopharmaceuticals can contain the metastable impurity [Lu]lutetium with a physical half-life of 160.4 days, in varying concentrations depending on the route of production of the radionuclidic precursor [Lu]lutetium. Due to the long half-life of [Lu]lutetium, difficulties with waste disposal or sterility testing could arise. Here, we analyzed several Lu-samples of different origins and suppliers regarding their Lu-concentration.
Results: All samples tested showed a Lu-concentration in the range that was stated on the certificate of analysis from the supplier which is in accordance with the European Pharmacopoeia.
Conclusions: Although all Lu-concentrations were in accordance with the European Pharmacopoeia, we need to take into account the respective national legislation regarding radioactivity release limits. With regard to the German legislation, several probes for sterility testing in external laboratories could not be released for transport due to the concentration of [Lu]lutetium. Moreover, waste water tanks should specifically be monitored for Lu-concentration, when e.g. Lutathera is administered in the clinic.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628054 | PMC |
| http://dx.doi.org/10.1186/s41181-023-00222-2 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!