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, 68 (12), 2293-7

GMP-compliant Automated Synthesis of [(18)F]AV-45 (Florbetapir F 18) for Imaging Beta-Amyloid Plaques in Human Brain

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GMP-compliant Automated Synthesis of [(18)F]AV-45 (Florbetapir F 18) for Imaging Beta-Amyloid Plaques in Human Brain

Cheng-Hsiang Yao et al. Appl Radiat Isot.

Abstract

We report herein the Good Manufacturing Practice (GMP)-compliant automated synthesis of (18)F-labeled styrylpyridine, AV-45 (Florbetapir), a novel tracer for positron emission tomography (PET) imaging of beta-amyloid (Abeta) plaques in the brain of Alzheimer's disease patients. [(18)F]AV-45 was prepared in 105 min using a tosylate precursor with Sumitomo modules for radiosynthesis under GMP-compliant conditions. The overall yield was 25.4+/-7.7% with a final radiochemical purity of 95.3+/-2.2% (n=19). The specific activity of [(18)F]AV-45 reached as high as 470+/-135 TBq/mmol (n=19). The present studies show that [(18)F]AV-45 can be manufactured under GMP-compliant conditions and could be widely available for routine clinical use.

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