GMP-compliant automated synthesis of [(18)F]AV-45 (Florbetapir F 18) for imaging beta-amyloid plaques in human brain.
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.
Yao
Cheng-Hsiang
CH
Department of Nuclear Medicine and Molecular Imaging Center, Chang Gung Memorial Hospital, Taiwan, ROC.
Lin
Kun-Ju
KJ
Weng
Chi-Chang
CC
Hsiao
Ing-Tsung
IT
Ting
Yi-Shu
YS
Yen
Tzu-Chen
TC
Jan
Tong-Rong
TR
Skovronsky
Daniel
D
Kung
Mei-Ping
MP
Wey
Shiaw-Pyng
SP
D000544:Alzheimer Disease / Q000000981:diagnostic imaging / Q000378:metabolism; D016229:Amyloid beta-Peptides / Q000378:metabolism*; D000814:Aniline Compounds; D001331:Automation; D002851:Chromatography, High Pressure Liquid; D005026:Ethylene Glycols; D005462:Fluorine Radioisotopes; D019983:Guideline Adherence; D006801:Humans; D049268:Positron-Emission Tomography
D016229:Amyloid beta-Peptides; D000814:Aniline Compounds; D005026:Ethylene Glycols; D005462:Fluorine Radioisotopes; C545186:florbetapir