GMP-compliant production of [68Ga]Ga-NeoB for positron emission tomography imaging of patients with gastrointestinal stromal tumor

EJNMMI Radiopharmacy and Chemistry

Table 1 Summary of the validation of the quality control methods fo [⁶⁸Ga]Ga-NeoB

Product identification – HPLC
*Selectivity*
Specification	P*	result	9.85 min
Specification	S*: t(P) - t(S) = 0.05 ± 0.035 min	result	9.80 min
Specification	V*: t(P) - t(V) > 0.25 min	result	9.48 min
Specification	G*: t(P) - t(G) > 0.25 min	result	0.68 min
*Precision*
Specification	P: mean + 3 s-value	result (n = 6)	9.73 ± 0.20 min
Radiochemical puritiy – HPLC
*Resolution R between G and P*
Specification	R > 1.5	result	R = 56.8
*Robustness*
Specification	P = 9.73 ± 0.20 min	result	9.77 min
*Limit of determination (S/N for 5 MBq/mL)*
Specification	S/N > 10	result	37.9
*Recovery*
Specification	W = 80–120%	result	87.3–92.7%
Comparison between RCP HPLC and TLC
Variance	0.7%	result	HPLC 98.5% TLC 99.2%
Product identification TLC
*Precision*
Specification	P R_f = 0.6–0.9	result	R_f = 0.72
Specification	G R_f = 0–0.1	result	R_f = 0.04
Specification	P: mean + 3 s-value	result (n = 6)	R_f = 0.72 ± 0.08
*Robustness*
Specification	P = 0.72 ± 0.08 min	result	0.69 min
Endotoxine test
Specification	‘pass’ < 2.5 EU/mL at 1:50	result (n = 6)	all ‘pass‘< 2.5 EU/mL

*P product [⁶⁸Ga]Ga-NeoB; S non-radioactive standard [⁶⁹Ga]Ga-NeoB; V precursor NeoB; G generator eluate pure ⁶⁸Ga³⁺