A Comparative Investigation of the Gel Chromatography Column Scanning Method for Quality Control of 99mTc-Methylenediphosphonate

L. Darte

doi:10.1055/s-0037-1620717

Nuklearmedizin - NuclearMedicine, Table of Contents

Nuklearmedizin 1981; 20(02): 51-63
DOI: 10.1055/s-0037-1620717

Originalarbeiten – Original Articles

Schattauer GmbH

A Comparative Investigation of the Gel Chromatography Column Scanning Method for Quality Control of ^99mTc-Methylenediphosphonate

Eine vergleichende Untersuchung des Gelchromatographie Säulen-Scanning für die Qualitätskontrolle von ^99mTc-Methylendiphosphonat

L. Darte

¹From the Department of Radiation Physics, University of Lund, Lasarettet, Lund, Sweden

› Author Affiliations

Abstract

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Gel chromatography column scanning (GCS) is the method of choice for quality control of ^99mTc-MDP preparations. Using this method all the labelled components are obtained rapidly in one simple test procedure. The influence of various parameters such as gel type, column size, prehistory of column, equilibration, eluent, elution volume and flow rate upon the results have been investigated. Test results for ^99mTc-MDP have been compared for several different GCS systems, a few TLC systems and column chromatography with fraction collection. The GCS technique, optimized for testing ^99mTc-MDP preparations, has been applied in a few experiments in which very good reproducibility is required: Labelling kinetics and stability when stored at room temperature or in a refrigerator and influence of the ^99mTc/(^99mTc + ⁹⁹Tc) atomic ratio and of the amount of radioactivity on the ^99mTc-MDP labelling yield, covering parameter ranges of clinical interest, have been studied.

Gelchromatographie Säulen-Scanning (GCS) ist die Methode der Wahl für die Qualitätskontrolle von ^99mTc-Methy-lendiphosphonat. Mit der GCS-Methode werden alle markierten Komponenten schnell in einem einzigen, einfachen Testverfahren erhalten. Die Beeinflussung der Ergebnisse durch verschiedene Parameter wie Gel-Type, Größe der Säule, Vorgeschichte der Säule, Gleichgewicht sowie Natur, Volumen und Geschwindigkeit des Elutionsmittels wurde untersucht. Prüfungsergebnisse von ^99mTc-MDP für verschiedene GCS-Systeme, einige Systeme der Dünnschichtchromatographie und konventionelle Gelchromatographie mit Sammlung von Eluatfraktionen wurden verglichen. Die optimale GCS-Technik zur Prüfung von ^99mTc-MDP-Präparaten wurde in einigen Experimenten angewendet, die sehr gute Reproduzierbarkeit erfordern: Kinetik der Markierung und Stabilität bei Zimmertemperatur und im Kühlschrank, Beeinflussung des ^99mTc/(^99mTc + ⁹⁹Tc) atomaren Verhältnisses und Beeinflussung der Radioaktivitätsmenge auf die Markierungseffizienz für Parameterbereiche von klinischer Bedeutung.

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References

References
1 Billinghurst M.W, Palser R.F. Gel chromatography as an analytical tool for ^99mTc-radiopharmaceuticals. J. Nucl. Med 1974; 15: 722.
2 Billinghurst M.W, Rempel S, Westendorf B.A. Radiation decomposition of technetium-99m radiopharmaceuticals. J. Nucl. Med 1979; 20: 138.
3 Darte L, Persson R.B.R. Some aspects on quality control and stability tests of ^99mTc-pyrophosphate for imaging myocardial infarcts. Nuc. Compact 1977; 8: 120.
4 Darte L, Persson R.B.R. Quality control of ^99mTc-radiopharmaceuticals. Evaluation of GCS minicolumns in routine clinical work with scintillation cameras. Eur. J. Nucl. Med 1980; 5: 521.
5 Darte L, Persson R.B.R. GCS Minicolumns for rapid and reliable quality control of ^99mTc-radiopharmaceuticals in routine clinical work. Report CODEN LUMEDW/(MERI-3022). Sweden: University of Lund; 1980: 1-19.
6 Darte L, Persson R.B.R, Söderbom L. Quality control and testing of ^99mTc-MAA. Nucl.-Med 1976; 15: 80.
7 Determann H. Gel chromatography. New York: Springer, Berlin/ Heidelberg/; 1969: p. 72
8 Dhawan V, Yeh S.D.J. Labeling efficiency and stomach concentration in methylene diphosphonate bone imaging. J. Nucl. Med 1979; 20: 791.
9 Lamson M.L, Kirschner A.S, Hotte CE, Lipsitz E.L, Ice R.D. Generator-produced ^99mTcO₄ ^-: Carrier free? J. Nucl. Med 1975; 16: 639.
10 Mattsson S. Technetium-99 in “instant” ^99mTc-pertechne-tate. J. Radioanal. Chem 1978; 45: 341.
11 Owunwanne A, Weber D.A, O’Mara R.E. Factors influencing paper chromatographic analysis of technetium-99m phosphorus compounds: Concise communication. J. Nucl. Med 1978; 19: 534.
12 Persson R.B.R, Darte L. Gel chromatography column scanning for the analysis of ^99mTc-labelled compounds. J. Chrom 1974; 101: 315.
13 Persson R.B.R, Darte L. Recent developments of the gel chromatography column scanning method. A rapid analytical tool in radiopharmaceutical chemistry. J. Labelled Compounds and Radiopharmaceuticals 1977; 13: 165.
14 Russell C. D, Majerik J.E. Determination of pertechne-tate in radiopharmaceuticals by high-pressure liquid, thin-layer and paper chromatography. Int. J. Appl. Radiat. Isot 1979; 30: 753.
15 Srivastava S.C, Meinken G, Smith T.D, Richards P. Problems associated with stannous ^99mTc-radiopharmaceuti-cals. Int. J. Appl. Radiat. Isotopes 1977; 28: 83.
16 Steigman J, Williams H.P, Richards P, Lebowitz E, Meinken G. Gel chromatography in the analysis of ^99mTc-radiopharmaceuticals. J. Nucl. Med 1974; 15: 318.
17 Subramanian G, McAfee J.G, Blair R.J, Thomas F.D. An evaluation of ^99mTc-labeled phosphate compounds as bone-imaging agents. In “Radiopharmaceuticals”. Soc. Nucl. Med., N.Y. (U.S.A.): 1975: p. 319
18 Valk P.E, Dilts C. A, McRae J. A possible artifact in gel chromatography of some ^99mTc-chelates. J. Nucl. Med 1973; 14: 235.
19 Van den Brand J.A.G.M, Das H.A, Dekker B.G, DE Ligny CL. . The influence of experimental conditions on the efficiency of the labelling of ^99mTc-EHDP, using Sn (II) as the reductant. Int. J. Appl. Radiat. Isotopes 1979; 30: 185.
20 Van den Brand J.A.G.M, Dekker B.G, DE Ligny C. L. . A comparative investigation of various Sephadex G-types and Bio-Gel P-10 in the gel chromatographic analysis of ^99mTc-EHDP. Int. J. Appl. Radiat. Isotopes 1979; 30: 129.