The two peptides DOTA-TATE and -NOC were labeled with 68Ga by heating for 15 min at 121 掳C in the presence of acetate buffer at pH 4.3. The product solutions were tested for sterility, presence of endotoxins, degradation of peptide and osmolality.
Complete incorporation of 68Ga was obtained after the autoclabeling reaction and no degradation of the peptides was observed. Sterility was verified and the presence of endotoxins was well within Ph. Eur limits (175IU/maximum injected volume).
The autoclabeling method provides a convenient procedure for 68Ga-labeling by combining the labeling reaction and steam sterilization into one single step.