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Resumo IPEN-doc 11822 Preparation and quality control of 99mTc-DMSA2006 - BERNARDES, DULCILA M.L.; CASTANHEIRA, CLAUDIA E.; CASTRO, JOSE A. de; MURAMOTO, EMIKO; PEREIRA, CLAUDIA R.; CAMPOS, DOMINGOS G. de; OSSO JUNIOR, JOAO A.99mTc-dimercaptosuccinic acid (DMSA) is considered an excellent kidney imaging agent and is indicated for evaluation of renal parenchymal disorders. After intravenous injection in humans, 99mTcDMSA becomes loosely bound to plasma protein (75% at 1 hour after injection, increasing to 90% by 24 hours), with little or no diffusion into red cells. Renal excretion is slow, with only 16% of the dose in urine 2 hours after injection. This report describes the validation of a new formulation of DMSA for routine production and quality control, in lyophilized form for labeled with 99mTc with 37 at 3,700 MBq. The process was done under vacuum and low temperature in Super Modulyo –“Edwards” lyophilizator and each lyophilized vial contains: 1.0 mg of DMSA; 0.44 mg SnCl2.H2O; 0.7 mg ascorbic acid and 50.0 mg inositol, pH = 2,5. The radiochemical purity was evaluated by thin layer chromatography system in Whatman 3MM paper(1 x 8 cm) and TLC-SG (Al) 1.5 x 12.5 cm, using acetone and 0.9% NaCl as solvents, respectively, at 30, 60, 120 and 240 minutes after labeling. The Rf value in acetone is 1.0 for 99mTcO4- and 0.0 for 99mTcO2- / 99mTc-DMSA and the Rf value in 0.9% NaCl is 1.0 for 99mTcO4- / 99mTc-DMSA and 0.0 for 99m TcO2-. The stability was evaluated during 6 months and the validation performed in 6 batches. The sterility and pyrogen tests were performed by the microbiology procedures outlined in the pharmacopoeias and by the “in-vitro” Limulus test, respectively. Biological distribution was evaluated in Wistar rats by i.v. of 8.8MBq / 0.100 mL. The% dose / organ in different tissues was determined at 1 h after dose. The method was validated for routine production at Radiopharmacy Center, with a stability of 6 month kept at 2–8ºC and with a radiochemical purity higher than 90%. The biological distribution in rats Radiofarmácia/Radioquímica Radiol Bras 2006;39(Suplemento nº 2):1–98 95 showed an uptake higher than 40% and 6% of injected dose in kidney and rate kidney/liver+spleen, respectively. Sterility and pyrogen tests were negative in all the delivered lyophilized vials. During the first 6 months in 2006, were distributed more than 1,200 lyophilized “kits” of DMSA at clinics and hospitals of nuclear medicine in Brazil.