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Pharmaceutical grade 3 0 -deoxy-3 0 -[ 18 F]fluorothymidine [ 18 F]FLT was synthesized using 3-N-Boc-5 0 -O-dimethoxytrityl-3 0 -O-nosyl-thymidine (BOC-Nosyl) precursor, in the general purpose TRACERlab FX modules. Purification of [ 18 F]FLT, via solid phase extraction (SPE) after radiosynthesis, using a combination of different SPE cartridges, yielded satisfactory results, with radiochemical and chemical purity >99%. While the non-decay corrected radiochemical yield (RCY) with 20 mg (24 μmole) of BOC-Nosyl precursor was found to be 6.80 ± 0.16%, the decay corrected radiochemical yield (RCY) was 9.95 ± 0.24%. Residual acetone, acetonitrile, and ethanol levels were found to be 22.97

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Introduction: The quality control parameters of in-house-produced 90 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 90 Y-DOTATATE in acceptable radiochemical purity (RCP), with expected pharmacological behavior in in vivo models, establish the quality of 90 Y-Acetate. Clinical translation of 90 Y-Acetate in formulation of 90 Y-DOTATATE adds support toward its use as clinicalgrade radiochemical. Methods: Quality control parameters of 90 Y-Acetate, namely radionuclide purity (RNP), were evaluated using bspectrometry, c-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 90 Y-Acetate as an active pharmaceutical ingredient radiochemical was ascertained by radiolabeling with DOTATATE. In vivo biodistribution of 90 Y-DOTATATE was carried out in nude mice bearing AR42J xenografted tumor. Clinical efficacy of 90 Y-DOTATATE was established after using in patients with large-volume neuroendocrine tumors (NET). Bremsstrahlung imaging was carried out in dualhead gamma camera with a wide energy window setting (100-250 keV). Results: In-house-produced 90 Y-Acetate was clear, colorless, and radioactive concentration (RAC) in the range of 40-50 mCi/mL. RCP was >98%. 90 Sr content was <0.85 lCi/Ci of 90 Y. Gross k content was <0.8 nCi/Ci of 90 Y and no c peak was observed. Fe 3+ , Cu 2+ , Zn 2+ , Cd 2+ , and Pb 2+ contents were <1.7 lg/Ci. The radiolabeling yield (RLY) of 90 Y-DOTATATE was >94%, RCP was >98%. The in vitro stability of 90 Y-DOTATATE was up to 72 h postradiolabeling, upon storage at -20°C. Post-therapy (24 h) Bremsstrahlung image of patients with large NET exhibit complete localization of 90 Y-DOTATATE in tumor region. Conclusions: This study demonstrates that the in-house-produced 90 Y-Acetate from HLLW can be used for the formulation of various therapeutic 90 Y-based radiopharmaceuticals. Since 90 Y is an imported radiochemical precursor available at a high cost in India, this study which demonstrates the suitability of indigenously sourced 90 Y, ideally exemplifies the recovery of ''wealth from waste.'' The Clinical Trial Registration number: (P17/FEB/2019).

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