Synthesis of LW223 precursor

Tender description

The development, manufacture, and supply of 1 gram of (R)-(N-sec-Butyl)-3-chloromethyl-N-methyl-4-phenylquinoline-2- carboxamide (i.e. [18F]LW223 precursor) alliquoted as 250 x 4 mg as well as 50 mg of (R)-N-(sec-butyl)-3-(fluoromethyl)-N-methyl-4-phenylquinoline-2-carboxamide (i.e. [18F]LW223 standard) for use in clinical trials. Manufacture of a precursor in accordance with GMP standards for APIs for use in clinical trials. The precursor will match set specifications. Racemic LW223 precursor (research grade) will be synthesized and used as impurity standard for chiral HPLC of the GMP precursor. LW223 standard material will be manufactured as research grade product. Re-test data, quantities of material and CMC documentation will be as detailed in the supplier's quotation.