Formulation of a kit under Good Manufacturing Practices (GMP) for preparing [111In]In-BnDTPA-trastuzumab-NLS injection: a theranostic agent for imaging and Meitner-Auger Electron (MAE) radioimmunotherapy of HER2-positive breast cancer

EJNMMI Radiopharmacy and Chemistry

Table 3 Quality testing results for 15 sequential lots of ¹¹¹In[In]-BnDTPA-trastuzumab-NLS injection

Parameter	Specification	Mean ± SD (n = 15)
Specific activity	20–33 MBq/mg	24.0 ± 1.2 MBq/mg
pH	5.5–6.0	6.0 ± 0.0
Appearance	Clear, pale yellow, particle-free	Passed
Radiochemical purity	≥ 90%	98.4 ± 0.01%
Sterility (retrospective)	USP Sterility Test	Passed