Nghiên cứu pha chế và kiểm tra chất lượng thuốc phóng xạ 68Ga-Dotatate tại Bệnh viện Chợ Rẫy

Abstract

Objective: We introduce the production and quality control of ⁶⁸Ga-Dotatate at Cho Ray Hospital. Subject and method: The production of ⁶⁸Ga-Dotatate radiopharmaceutical was conducted in the iQS® Ga-68 Fluidic Labeling Module (ITG, Germany) using the ⁶⁸Ge/⁶⁸Ga generators. The products in 5 batches are systematically measured with a series of analysis methods such as radiochemical purity, radionuclide identity, ⁶⁸Ge breakthrough test, bacterial endotoxin, etc. These obtained results are also compared to the requirement of EU pharmacopeia. Result: All products obtained in 5 batches also needs to the requirement of pharmacopeia and technical specifications from the manufacturer. As a result, the ⁶⁸Ga-Dotatate is a clear, colorless solution with an average radiochemical purity of 96.436% ± 0.065%, which was superior to 91% in the pharmacopeia standard. Conclusion: The ⁶⁸Ga-Dotatate radiopharmaceutical was successfully produced using the iQS^® Ga-68 Fluidic Labeling Module and the ⁶⁸Ge/⁶⁸Ga generator at Cho Ray hospital. In future work, the ⁶⁸Ga-Dotatate radiopharmaceutical will be used in PET/CT imaging for diagnosing, monitoring, and therapy planning of NETs for patients at Cho Ray Hospital.