Quality criteria of the radiopharmaceutical suspensions used in radiosynoviorthesis
| Autor: | Jorge Cruz Arencibia, Amed Cruz Morales, Jorge Izquierdo Pérez, José Morín Zorrilla |
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| Jazyk: | English<br />Spanish; Castilian |
| Rok vydání: | 2017 |
| Předmět: | |
| Zdroj: | Nucleus, Vol 0, Iss 62, Pp 34-37 (2017) |
| Druh dokumentu: | article |
| ISSN: | 0864-084X 2075-5635 |
| Popis: | The quality criteria of radioactive dispersions used in radiosynovectomy are examined, taking into account the requirements of the Pharmacopoeia for the Chromic Phosphate P-32 of Mallinckrodt, recommendations for the use of approved radiopharmaceuticals of the European Association of Nuclear Medicine and data provided by others marketing firms. The behavior of two formulations of chromic phosphate, one 32P-labeled and the second 90Y-labeled, from the point of view of the consistency (reproducibility) of both the radiochemical purity and the particle size distribution was assayed. It is proven that the presence of 5% of free phosphate admitted in the Mallinckrodt formulation, and extended to the presence of ionic forms of other radiopharmaceuticals of different matrices, is probably due to the inevitable effect of steam sterilization on the suspension. Based on these results and the accumulated clinical experience, it is considered that to establish the quality requirements of the radioactive suspensions for radiosynovectomy, more attention should be paid to the particle size distribution than to the percentage of free ionic forms. The first one is more related to the efficacy and safety of this kind of radiopharmaceuticals. |
| Databáze: | Directory of Open Access Journals |
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