Controle de qualidade de marcações de PSMA-11, utilizando um gerador itinerante de Ge68 ­ Ga68 para estudos de PET-CT / Quality control of PSMA-11 markings using a Ge68-Ga68 itinerant generator for PET-CT studies

Introdução: este estudo trata do controle de qualidade do radiofármaco utilizado em estudos de PET-CT para diagnóstico e/ou estadiamento de pacientes acometidos pelo câncer de próstata. Objetivo: avaliar a qualidade do radiofármaco PSMA-11, marcado com uso de gerador de Ge68-Ga68 itinerante. Metodologia: análise do aspecto visual, pH e pureza radioquímica do radiofármaco marcado a cada recebimento do gerador de Ge68-Ga68. Resultado: todas as marcações realizadas se apresentaram límpidas quanto ao aspecto visual, o pH ficou entre 5,0 e 6,0 e a pureza radioquímica apresentou em 92% dos casos valores ≥ 96%. Conclusão: com os devidos controles de qualidade, pode ser uma opção para uso na clínica médica, em serviços que não disponham de condição para adquirir um sistema, por ser importado.

Introduction: this study works with the quality control of the radiopharmaceutical used in PET-CT studies for diagnosis and / or staging of patients affected with prostate cancer. Objective: evaluate the quality of the PSMA-11 marked radiopharmaceutical using a Ge68-Ga68 itinerant generator. Methodology: analysis of the visual aspect, pH and radiochemical purity of the marked radiopharmaceutical on each receiving of the Ge68-Ga68 generator. Results: all performed markings were clear in terms of visual appearance, pH was between 5.0 and 6.0 and radiochemical purity was 92% with value ≥ 96%. Conclusion: with proper quality controls it can be an option for application in the medical clinic, services centers unable to purchase a system due to importation process.

Current Approach in Radiochemical Quality Control of the 99mTc-Radiopharmaceuticals: a mini-review

Abstract To present optimized chromatographic systems for radiochemical purity (RCP) evaluation of 99mTc-eluate and 99mTc-radiopharmaceuticals, as well as to assess doses calibrator reliability for routine purposes in hospital radiopharmacies. RCP was determined by different systems and radioactivity was quantified by TLC-scanner, doses calibrator and gamma-counter. Suitable and optimized systems were presented for RCP analyses. No significant differences were observed between radioactivity counting devices and, thus, doses calibrator showed reliability for RCP determination in hospital radiopharmacies.

Analysis of ~(18)F-fludeoxyglucose Injection by Silica Gel TLC / 中国药房

OBJECTIVE: To analyze 18F-fludeoxyglucose injection by Silica Gel TLC method.METHODS: TLC was adopted in which 18F-fludeoxyglucose injection(A) and mixture solution of 18F-FDG injection-acetonitrile(5∶95,V/V)(B) were used as testing solution.GF silica plate and G silica plate were used as stationary phase,and the mobile phase was acetonitrile: water(95∶5,V/V).RESULTS: The main peak Rf of testing solution A had a great fluctuation;The main peak Rf of testing solution B was 0.38～0.40.Radiochemical purity of 18F-fludeoxyglucose was more than 98%,and the Rf of radioimpurity 18F-and the by-product 18F-fludeoxymannose stood at 0.0 and 0.78 respectively.CONCLUSION: When testing solution B,the process of silica gel thin-layer chromatographic analysis is stable and reproducible,and the results meets the requirements specified in USP and are independent of the category of silica plate.