Analysis of Na2B12H11SH for Neutron Capture Therapy Nuclear Medicine, Inc. (NMI), is intent on commercializing an alternate from of radiation therapy known as Boron Neutron Capture Therapy (BNCT). This therapy is currently and successfully being used in Japan for the treatment of brain tumors. FDA requires chemical characterization of Na2B12H11SH, and the pharmaceutical that makes the therapy possible, before it approves clinical trials for BNCT in the United States. NMI has obtained Orphan Drug status for Na2B12H11SH, and proposes two different quantitative methods for measuring its purity: Track-Etch/Thin Layer Chromatography (TLC) and High Performance Liquid Chromatography (HPLC). The former method allows the sensitive measurement of the 10B isotope in the boron polyhedron. Measurement by HPLC is based on analysis of the sulfhydryl group on B12H11SH2-- by electrochemical means. The techniques thus complement one another, and can be symbiotically applied to both chemical and biochemical analysis of boron-carrier compounds. All past efforts in this country on behalf on BNCT, while supplying a wealth of information, have been narrowly focused on specific research aims. NMI is focused on commercialization of BNCT within this decade. Implementing Track-Etch/TLC and HPLC analysis of Na2B12H11SH will put NMI closer to this goal.
