Nuclear Medicine, Inc. (NMI) intends to commercialize an alternate form of radiation therapy known as boron neutron capture therapy (BNCT). This therapy is currently and successfully being used in Japan to treat brain tumors. The Food and Drug Administration requires chemical characterization of Na2Bl2HllSH, the pharmaceutical that makes the therapy possible, before it will approve clinical trials for BNCT in the United States.NMI has obtained orphan drug status for Na2Bl2HllSH and proposes two different quantitative methods for measuring its purity: track-etch/thin-layer chromatography (TLC) and highperformance 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 BH1lSH2- by electrochemical or other means. The techniques thus complement one another and can be symbiotically applied to both chemical and biochemical analysis of boron-carrier compounds.National Cancer Institute (NCI)
