Review and Suggestions for the Preparation and Quality Control of ⁶⁸Ga-PSMA-11 Injection

In this study, a standardized preparation process for 68Ga-PSMA-11 injection was developed by optimizing the labeling conditions, and the quality control standards of ⁶⁸Ga-PSMA-11 injection applicable to our institution were formulated by combining domestic and international pharmacopoeias. Reviewing the preparation and quality control results of a total of 316 batches of ⁶⁸Ga-PSMA-11 injections from 2020—2022, it was found that all batches were successfully prepared to obtain ⁶⁸Ga-PSMA-11 injections, and the quality control results were in full compliance with the proposed standards. The labeling rate of ⁶⁸Ga-PSMA-11 was （85.3±11.4）%, and it was decreased significantly with increasing total elution volume of ⁶⁸Ge/⁶⁸Ga generator, while the elution interval time had little effect on the labeling rate. This study is expected to guide nuclear medicine practitioners to standardize the preparation and quality control process of ⁶⁸Ga-PSMA-11 injection, thus improving the quality and safety of the drug, and providing a reference for related industry standards.