Preparation and quality control of 99mTc-DMSA
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2006
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Radiologia Brasileira
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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.
Como referenciar
BERNARDES, DULCILA M.L.; CASTANHEIRA, CLAUDIA E.; CASTRO, JOSE A. de; MURAMOTO, EMIKO; PEREIRA, CLAUDIA R.; CAMPOS, DOMINGOS G. de; OSSO JUNIOR, JOAO A. Preparation and quality control of 99mTc-DMSA. Radiologia Brasileira, v. 39, p. 94-95, 2006. Disponível em: http://repositorio.ipen.br/handle/123456789/8763. Acesso em: 20 Mar 2025.
Esta referência é gerada automaticamente de acordo com as normas do estilo IPEN/SP (ABNT NBR 6023) e recomenda-se uma verificação final e ajustes caso necessário.