On the Separation of Yttrium-90 from High-Level Liquid Waste: Purification to Clinical-Grade Radiochemical Precursor, Clinical Translation in Formulation of 90 Y-DOTATATE Patient Dose

The quality control parameters of in-house-produced Y-Acetate from high-level liquid waste (HLLW) using supported liquid membrane (SLM) technology were validated and compared with the pharmacopeia standard. The radiolabeling of DOTATATE yielding Y-DOTATATE in acceptable radiochemical purity (RCP), with expected pharmacological behavior in models, establish the quality of Y-Acetate. Clinical translation of Y-Acetate in formulation of Y-DOTATATE adds support toward its use as clinical-grade radiochemical. Quality control parameters of Y-Acetate, namely radionuclide purity (RNP), were evaluated using β spectrometry, γ-spectroscopy, and liquid scintillation counting. RCP and metallic impurities were established using high-performance liquid chromatography and inductively coupled plasma optical emission spectrometry, respectively. The suitability of Y-Acetate as an active pharmaceutical ingredient radiochemical was ascertained by radiolabeling with DOTATATE. biodistribution of Y-DOTATATE was carried out in nude mice bearing AR42J xenografted tumor. Clinical efficacy of Y-DOTATATE was established after using in patients with large-volume neuroendocrine tumors (NET). Bremsstrahlung imaging was carried out in dual-head gamma camera with a wide energy window setting (100-250 keV). In-house-produced Y-Acetate was clear, colorless, and radioactive concentration (RAC) in the range of 40-50 mCi/mL. RCP was >98%. Sr content was