Artefacts in the thin-layer chromatographic analysis of 99Tcm-tetrofosmin injections

Graham, D.; Millar, A. M.

doi:10.1097/00006231-199905000-00007

Cited by 9 publications

(3 citation statements)

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“…To minimize the effect of the slower migration on GMCP-SA, the origin was marked 15 mm from the bottom and a run length of 100 mm was maintained. In view of the problems that are known to be caused by heat activation of ITLC-SG, 6 GMCP-SA plates were used without activation.…”

Section: Discussionmentioning

confidence: 99%

An evaluation of GMCP‐SA as a replacement for ITLC‐SG when measuring the levels of radiochemical impurities in ^99mTc radiopharmaceuticals by thin‐layer chromatography

Millar

Beattie

Craig

et al. 2009

Labelled Comp Radiopharmac

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Background:The European Pharmacopoeia and radiopharmaceutical manufacturers specify Instant Thin-Layer Chromatography Silica Gel impregnated glass fibre (ITLC-SG) as the stationary phase for measuring the radiochemical purity (RCP) of most technetium-99m ( 99m Tc) radiopharmaceuticals. During 2008, The Pall Corporation stopped manufacturing ITLC-SG. A replacement is required. Aim: To evaluate Varian's Glass Microfibre Chromatography Paper impregnated with salicic acid (GMCP-SA) as a replacement. Experimental: Samples of six 99m Tc radiopharmaceuticals (albumin nanocolloid, colloidal tin, exametazime, medronate, pentetate and succimer) were prepared containing levels of radiochemical impurities between 0 and 10%. Samples were tested using ITLC-SG and GMCP-SA with the mobile phase specified in the pharmacopoeia or by the manufacturer. Analysis was performed by thin-layer radiochromatogram scanning. Results: For measuring the RCP of albumin nanocolloid, colloidal tin, exametazime and succimer, GMCP-SA is a suitable replacement for ITLC-SG. For medronate, GMCP-SA is suitable for measuring colloidal 99m Tc impurity despite producing slightly higher values than ITLC-SG, but unsuitable for measuring 99m Tc pertechnetate impurity due to significant over-estimation. For pentetate, GMCP-SA is suitable for measuring colloidal 99m Tc impurity but gives slightly higher values for 99m Tc pertechnetate impurity than ITLC-SG. Conclusion: GMCP-SA is a suitable alternative to ITLC-SG for analysing some 99m Tc radiopharmaceuticals but is not a universal replacement.

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Section: Discussionmentioning

confidence: 99%

An evaluation of GMCP‐SA as a replacement for ITLC‐SG when measuring the levels of radiochemical impurities in ^99mTc radiopharmaceuticals by thin‐layer chromatography

Millar

Beattie

Craig

et al. 2009

Labelled Comp Radiopharmac

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“…Examples of typical applications of HPLC for separation of 99m Tc-labelled species are shown in Table 9.1.2.2. The most frequently used HPLC techniques (Hnatowich 1986;) are reversed-phase partition chromatography for nonpolar or weakly polar components of 99m Tc pharmaceuticals (HMPAO [Hung et al 1988;Weisner et al 1993], monodentate methoxyisobutyl isocyanide [MIBI; Carvalho et al 1992;, mercaptoacetyltriglycine [MAG 3 ;Brandau et al 1990;Coveney and Robbins 1987;Millar et al 1990;Shattuck et al 1994], tetrofosmin [Cagnolini et al 1998;Graham and Millar 1999;], iminodiacetic acid [IDAs; Fritzberg and Lewis 1980;, peptides [Vallabhajosula 1986;Zinn et al 2000], etc. ), ion-pair (both ionized and less polar constituents: pertechnetate, diphosphonates; De Groot et al 1986 b;Hoch and Pinkerton 1986;Huigen et al 1988;Nieuwland et al 1989;Tanabe et al 1983, etc.…”

Section: Determination Of Radiochemical Puritymentioning

confidence: 99%

Technetium-99m Pharmaceuticals

Zolle¹

2007

103

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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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“…Contudo, alguns cuidados devem ser tomados, de modo a se evitar ocorrências de artefatos no desenvolvimento da cromatografia, como os observados quando amostras foram aplicadas nas fases estacionárias, deixadas secar e depois desenvolvidas com a fase móvel (95,96) .…”

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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Artefacts in the thin-layer chromatographic analysis of 99Tcm-tetrofosmin injections

Cited by 9 publications

References 0 publications

An evaluation of GMCP‐SA as a replacement for ITLC‐SG when measuring the levels of radiochemical impurities in ^99mTc radiopharmaceuticals by thin‐layer chromatography

An evaluation of GMCP‐SA as a replacement for ITLC‐SG when measuring the levels of radiochemical impurities in ^99mTc radiopharmaceuticals by thin‐layer chromatography

Technetium-99m Pharmaceuticals

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

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Artefacts in the thin-layer chromatographic analysis of 99Tcm-tetrofosmin injections

Cited by 9 publications

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An evaluation of GMCP‐SA as a replacement for ITLC‐SG when measuring the levels of radiochemical impurities in 99mTc radiopharmaceuticals by thin‐layer chromatography

An evaluation of GMCP‐SA as a replacement for ITLC‐SG when measuring the levels of radiochemical impurities in 99mTc radiopharmaceuticals by thin‐layer chromatography

Technetium-99m Pharmaceuticals

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

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An evaluation of GMCP‐SA as a replacement for ITLC‐SG when measuring the levels of radiochemical impurities in ^99mTc radiopharmaceuticals by thin‐layer chromatography

An evaluation of GMCP‐SA as a replacement for ITLC‐SG when measuring the levels of radiochemical impurities in ^99mTc radiopharmaceuticals by thin‐layer chromatography