Quality control of colloid and particulate 99mTc-labeled radiopharmaceuticals

Belkas, E.P.; Archimandritis, Spyridon C.

doi:10.1007/bf00263307

Cited by 9 publications

(2 citation statements)

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“…Electrophoresis has been used for quality control of certain radiopharmaceuticals (Belkas and Archimandritis 1979;Pauwels and Feitsma 1979). Paper electrophoresis has been applied successfully for the determination of the relative charge on some 99m Tc complexes.…”

Section: Gy Jnokimentioning

confidence: 99%

Technetium-99m Pharmaceuticals

Zolle¹

2007

105

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Foreword 99m Tc pharmaceuticals mark the beginning of diagnostic nuclear medicine and have contributed to patient care worldwide. Since the short-lived radionuclide was introduced for thyroid imaging in 1964, it has attracted much attention and stimulated clinical research. Little was known about element 43, except that it was an artificial radionuclide obtained by the radioactive decay of molybdenum-99. No wonder specialists from all fields joined medical institutions in the United States to participate in the exploration of its chemistry.This textbook gives an account of the accomplishments related to the development of 99m Tc pharmaceuticals and their application in diagnostic nuclear medicine. Since radioactive drug development is a multidisciplinary task, experts working in nuclear medicine and research institutions have contributed valuable information concerning the preparation with sterile kits, methods of quality control, and the use of 99m Tc pharmaceuticals in patients. In addition, the legal aspects governing production and clinical application are also considered.99m Tc pharmaceuticals in nuclear medicine are presented in two parts. Part 1 includes basic principles and methods used for preparation and analysis, in particular the chemistry of technetium-99m and methods described for the synthesis of complexes and conjugates of technetium-99m, the characteristics and performance of the 99 Mo/ 99m Tc generator system, the importance of kits and formulations for one-step labeling, and safety aspects for labeling blood cells. Special emphasis is given to analytical methods verifying pharmaceutical quality. The quality standards of good manufacturing practice (GMP) for 99m Tc pharmaceuticals and purity standards of the pharmacopeia (European Pharmacopeia and United States Pharmacopeia) have been considered as part of the concept of quality assurance.Part 2 presents 26 monographs of 99m Tc pharmaceuticals, concerning the preparation and safe clinical application. Each monograph provides information on the characteristics of the radiotracer based on chemistry, factors affecting the preparation and in vivo stability, pharmacokinetics and elimination properties, as well as details concerning the clinical application. For each clinical procedure, the effective radiation dose of the patient has been calculated. Methods recommended for quality control and actual results are included.Each radiopharmaceutical is listed under the name used in daily practice. The chemical name, the abbreviated name, and the officinal name in the pharmacopeia are also stated. Listing the trade names may facilitate understanding, especially when relating to products in the literature, which over the years have changed manufacturers.The presentation of 99m Tc pharmaceuticals as monographs serves a practical purpose: it offers relevant information on kit preparation and clinical application at a glance. These monographs provide a wide spectrum of information on 99m Tc pharmaceuticals for daily practice in nuclear medicine, serving as a r...

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Section: Gy Jnokimentioning

confidence: 99%

Technetium-99m Pharmaceuticals

Zolle¹

2007

105

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“…Excesso para a determinação de colóide em radiofármacos que formam agregados, a exemplo do 99m Tc-enxofre coloidal e dos 99m Tc-agregados de albumina (87,88) . Sistemas alternativos aos oficiais também foram apresentados para os novos radiofármacos, como o uso da ITLC-SG (89) , papel Whatman 3MM (90) e Whatman 1MM (91) para o 99m Tc-MIBI; ITLC-SG para o 99m Tc-MAG 3 (92) ; papel Whatman 3MM para o 99m Tc-ECD (93) ; ITLC-SG para o 99m Tc-tetrofosmin (94) .…”

Section: Atividadeunclassified

Alguns aspectos sobre geradores e radiofármacos de tecnécio-99m e seus controles de qualidade

2001

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Radiofármacos marcados com tecnécio-99m são os principais agentes para diagnósticos utilizados nas clínicas de medicina nuclear, em função de uma série de características físicas do radionuclídeo e pela praticidade dos radiofármacos serem preparados no local de uso, por meio de uma reação de complexação entre um agente complexante (fármaco) e o tecnécio-99m. Entretanto, durante esta reação podem ser geradas algumas impurezas que proporcionam a formação de produtos com baixa qualidade ou com características diferentes das desejadas. No presente trabalho serão apresentados alguns dos fatores que podem interferir na qualidade dos radiofármacos e os controles que podem ser utilizados para garantir sua qualidade.

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Radioanalytical Techniques: ITLC, TLC, Mini-Columns, and Electrophoresis

CarpenterJr.¹

1986

Analytical and Chromatographic Techniques in Radiopharmaceutical Chemistry

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Quality control of colloid and particulate 99mTc-labeled radiopharmaceuticals

Cited by 9 publications

References 0 publications

Technetium-99m Pharmaceuticals

Technetium-99m Pharmaceuticals

Alguns aspectos sobre geradores e radiofármacos de tecnécio-99m e seus controles de qualidade

Radioanalytical Techniques: ITLC, TLC, Mini-Columns, and Electrophoresis

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