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.