99mTc labeled genistein kits: development methods and quality control for breast cancer radiotracer applications

Objective. Selective estrogen receptor modulators (SERMs) have been widely used to treat breast cancer, osteoporosis, and postmenopausal symptoms. SERMs have an affinity for estrogen receptors (ER) in target tissues and resist stimulation of the breast, bone, and endometrium. Genistein as an isoflavone compound that has a high affinity for ERβ targets makes it a potential target or prognostic marker for breast cancer. This study was carried out to develop 99mTc-genistein kit that can be used to detect breast cancer. Methods. The synthesis process and quality control were investigated to obtain the optimal formula for the ratio of a substance, reducing agent, optimal conditions of the synthesis reaction, physicochemical properties of the kit, and its stability to meet the requirements of radiochemical purity. Results. The radiochemical purity in the development of the radiopharmaceutical kit was 93.25% ± 0.30%. The physicochemical properties of the kit preparations showed hydrophilic properties, good plasma protein binding, no electrical charge, and were stable at storage temperatures. Conclusions. The radiochemical purity of the radiopharmaceutical kits meets the requirements of the United State Pharmacopeia and has good physicochemical properties to be developed into kits.