Validation of chromatographic analytical methods, TLC and HPLC, to determine the radiochemical purity on the radiopharmaceutical [177Lu]-PSMA I&T
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Resumo
The Energy and Nuclear Research Institute (IPEN) is studying the production of the
radiopharmaceutical [177Lu]-PSMA I&T, in accordance with the good manufacturing practices
recommended by ANVISA, to be used in the therapy of prostate cancer. This work aims to
validate chromatographic methods, TLC and HPLC, to determine the radiochemical purity of
the product. The entire validation process of this work was based on ANVISA's RDC 166, 2017
and the Guide 10, version 1, 2017, guided the statistical treatments adopted. The selectivity
study found that the presence of impurities or excess excipients did not interfere with product
quantification. The proposed methods were linear with linear correlation coefficients (r) above
0.99. The precision and repeatability presented relative standard deviation values lower than
specified (RSD < 5 %). The small controlled variations in the method suggested for the
robustness test also did not affect the radiochemical purity of the product. In view of the
results and in accordance with the criteria established by the National Health Surveillance
Agency (ANVISA), the two chromatographic methods were validated in accordance with RDC
166, 2017, proving to be selective, precise, linear and robust. The validation of TLC and HPLC
methods enables their application in the batch release routine of the new radiopharmaceutical
at Radiopharmacy Center of IPEN
Como referenciar
SANTOS, JOEL M.; BALIEIRO, LUIZA M.; SANTOS, RODRIGO S.; MATSUDA, MARGARETH M.N.; ARAUJO, ELAINE B. Validation of chromatographic analytical methods, TLC and HPLC, to determine the radiochemical purity on the radiopharmaceutical [177Lu]-PSMA I&T. SSRN Electronic Journal, p. 1-9, 2024. DOI: 10.2139/ssrn.4920580. Disponível em: https://repositorio.ipen.br/handle/123456789/50070. Acesso em: 30 Jun 2026.
Esta referência é gerada automaticamente de acordo com as normas do estilo IPEN/SP (ABNT NBR 6023) e recomenda-se uma verificação final e ajustes caso necessário.