Validation of a radiosynthesis method and a novel quality control system for [ Ga]Ga-MAA: is TLC enough to assess radiopharmaceutical quality?

Background: Technetium-99 m-labelled macroaggregated human serum albumin ([99mTc]Tc-MAA) is commonly used for lung perfusion scintigraphy. The European Pharmacopoeia (Eu.Ph.