Table 2.

Stability testing of ⁶⁸Ga-DOTA-MGS5 up to 3 h after preparation.

Stability Testing	Acceptance Criteria	1 h	2 h	3 h
Free or colloidal gallium-68 (retardation factor <0.2)	≤3%	0.5 ± 0.3	0.5 ± 0.4	0.6 ± 0.2
Radiochemical purity	≥91%	94.3 ± 1.2	92.9 ± 1.0	92.9 ± 1.5
DOTA-MGS5, 68Ga-DOTA-MGS5 and related substances (RRT 0.8–1.2)	≤50 µg/V	<40	<40	<40