Validation of chromatographic methods, TLC and HPLC, to quantify known radiochemical impurities and the radiochemical purity the radiopharmaceutical [Lu]Lu-PSMA I&T.

The Energy and Nuclear Research Institute (IPEN) is studying the production of the radiopharmaceutical [Lu]Lu-PSMA I&T, in accordance with the good manufacturing practices recommended by the National Health Surveillance Agency (ANVISA), to be used in the therapy of prostate cancer. This work aims to validate chromatographic methods, Thin-Layer Chromatographic (TLC) and high-performance liquid chromatography (HPLC), to determine the radiochemical purity (RCP) of the product. The entire validation process of this work was based on ANVISA's RDC 166, 2017 and the Guide 10, version 1, 2017, guided the statistical treatments adopted.

A new Xe irradiation system for I production.

Since 2001, Nuclear and Energy Research Institute IPEN-CNEN has produced weekly ultrapure iodine-123, using a manual irradiation system, fully developed in IPEN. Iodine-123 radiopharmaceuticals have been produced and distributed to hospitals and clinics of nuclear medicine, where several diagnostic imaging procedures for thyroid, brain and cardiovascular functions are performed. Due to the short half-life and emission of low-energy photons, this radioisotope becomes suitable for diagnosis in children.

Knee radiosynovectomy with Sm-hydroxyapatite compared to Y-hydroxyapatite: initial results of a prospective trial.

Introduction: Radiosynovectomy (RS) with Y-hydroxyapatite (Y-HyA) aims to control knee hemarthrosis in hemophiliac patients to prevent secondary arthropathy. However, knee RS using Sm-hydroxyapatite (Sm-HyA) is considered less suitable due to the lower average soft tissue range and energy of Sm for large joints, such as the knees.

Purpose: The objective of this investigation was to assess the efficacy and safety of knee RS with Sm-HyA, compared to Y-HyA.

Study of the radiation effect of 99Mo/99mTc generator on Bacillus subtilis and Bacillus pumilus species.

In this work, molybdenum-99 loaded columns were challenged with Bacillus subtilis vegetative cells and Bacillus pumilus spores inside and outside the alumina column, and microbial recovery and radiation effect were assessed. Alumina was a barrier for the passage of microorganisms regardless the species, whilst spores were more retained than vegetative cells with a lower microbial recovery, without significant differences between 9.25 and 74 GBq generators.

Selective polarographic determination of stannous ion in technetium radiopharmaceutical cold kits.

Unlabelled: The aim of this work was to develop a selective method for quantification of Sn(II) and Sn(IV) in dimercaptosuccinic acid (DMSA), ethylcysteinate dimer (ECD), methylenediphosphonic acid (MDP), and pyrophosphate radiopharmaceutical cold kits by differential pulse polarography.

Methods: A dripping mercury electrode 150 polarographic/stripping analyzer with a conventional 3-electrode configuration was used with 3 M H(2)SO(4) and 3 M HCl supporting electrolytes for Sn(II) and Sn(IV), respectively. The polarographic analysis was performed using a 1-s drop time, 50-mV·s(-1) scan rate, -50-mV pulse amplitude, 40-ms pulse time, and 10-mV step amplitude.

A portable test system for determination of bacterial endotoxins in 18F-FDG, 99mTc, and lyophilized reagents for labeling with 99mTc.

Unlabelled: A rapid quantitative kinetic chromogenic test in an automated portable test system has been developed for in-process and end-product determination of bacterial endotoxins in water using the Limulus amebocyte lysate. The aim of this work was to validate the method for (18)F-FDG, (99m)Tc, and the lyophilized reagents methylene diphosphonic acid (MDP) and pyrophosphate for labeling with (99m)Tc radiopharmaceuticals with no interfering factors.

Methods: Experiments were performed on 3 consecutive batches of (18)F-FDG, (99m)Tc, MDP, and pyrophosphate produced at the Nuclear Energy and Research Institute of São Paulo, Brazil, using a portable test system.