• Armend Jashari Clinical Service of Nuclear Medicine - Hospital and University Clinical Service of Kosovo
  • Jasna Grozdanovska University Goce Delcev Stip, Faculty of Medical Sciences, Republic of North Macedonia
  • Yll Kaçiu Clinical Service of Nuclear Medicine - Hospital and University Clinical Service of Kosovo
  • Liljana Makraduli Replek farm – Skopje, Republic of North Macedonia
  • Ljubica Adzi-Andov Amedela Laboratory, Skopje, Republic of North Macedonia
  • Emilija Janevik-Ivanovska University Goce Delcev Stip, Faculty of Medical Sciences, Republic of North Macedonia


Quality control, Radiochemical purity, Instant Thin Layer Chromatography Medium (ITLC), 99m Tc-Tektrotyd


The new Radiopharmacy in Nuclear Medicine department in the Hospital and University Service of Kosovo apply the policy that all products administered into the human body, especially the new one are safe and show a constant high quality in producing the required effects. To ensure the efficacy of radiopharmaceuticals prepared at department in the Hospital and University Service of Kosovo, we introduced a cost-effective routine chromatographic method.

The radiochemical purity (RCP) of 99m-Technetium labelled radiopharmaceuticals (RP) is important to ensure optimal scintigraphic image quality. In a new hospital radiopharmacy unit it may not be possible to use compendial analytical methods or expensive equipment for radiochemical purity analysis, but all radiochemical analysis methods should however be validated against compendial or otherwise proven methods.

Our goal was to optimize the radiolabeling protocol for the regular use of 99m Tc-Tektrotyd and to establish chromatographic method for quality control after labelling as a part of our daily diagnostic procedures for assessment of NET patients labelled with 99m-Technetium was for the first time used to identify medical problems related to overexpression of somatostatin receptors, particularly subtype 2 and, to a lesser extent subtype 3 and 5.

Methods: Tektrotyd or HYNIC – (D-Phe1, Thyr3-Octreotide) trifluoroacetate (Polatom) radiopharmaceutical were reconstituted with about 2 000 MBq of freshly eluted sodium pertechnetate as described by the manufacturer and spiked with eluate of the same generator to obtain a range of impurity concentrations. Samples of technetium- 99m Tektrotyd were spotted on 1x15 cm ITLC-SG strips and developed in appropriate mobile phases described by the manufacturer. Each strip was immediately cut into 30 pieces of 0.5cm and the radioactivity of each piece was measured in a dose calibrator (Capintec,Inc).

The percentage of RCP for each ITLC strip was calculated using the total the radioactivity and the radioactivity from each segment as the total present radioactivity from which the basic radioactivity was subtracted. The present plotted radioactivity in the obtained peaks corresponded to the distribution of radioactivity, i.e. to the present complex of 99mTc Tektrotyd.

Results and Discussion: The proposed method proved to be accurate and precise within the RCP range of approximately 90% to 100% in comparison of the producer requirements.

Conclusion: The proposed method is suitable as a reliable low-cost method for limited resource settings and small hospital radiopharmacy unit.


Decristoforo, C., & Zolle, I. (2007).Quality Control Methods of 99mTc Pharmaceuticals. In Zolle I, (ed.). Technetium-99m Pharmaceuticals; Preparation and Quality Control in Nuclear Medicine. Berlin Heidelberg. New York: Springer; pp. 123-143

Decristoforo, C., Mather, S.J., Cholewinski, W., Donnemiller, E., Riccabona, G., & Moncayo, R. (2000). 99mTc-EDDA/HYNIC-TOC: a new 99mTc-labelled radiophar- maceutical for imaging somatostatin receptor-positive tumours; first clinical results and intra-patient comparison with 111In-labelled octreotide deriva- tives. Eur J Nucl Med; 27: 1318–1325.

Dondi, M., Kashyap, R., Paez, D., Pascual, T., Zaknun, J., Mut, F, et al. (2011). Trends in Nuclear Medicine in developing countries. Journal of Nuclear Medicine;52:16S-23S

Elsinga, P., Todde, S., Penuelas, I., Meyer, G., Farstad, B., Faivre-Chauvet, A., et al. (2010). Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. European Journal of Nuclear Medicine and Molecular Imaging; 37:1049-1062

European Directorate for the Quality of Medicines & HealthCare: Guide for the elaboration of monographs on Radiopharmaceutical Preparations. 2018. pharmaceutical_preparations_october_2018.pdf [Accessed 15 September 2019]

Faria, D.P., Buchpiguel, C.A., & Marques, .FL.N. (2015). Alternative chromatographic system for the quality control of lipophilic technetium-99m radiopharmaceuticals such as [99mTc(MIBI)6]+. Brazilian Journal of Medical and Biological Research;48:902-907

IAEA. (2008). Operational Guidance on Hospital Radiopharmacy, A safe and Effective Approach. Vienna: International Atomic Energy Agency;. pp. 28-30

IAEA. (2016). Good practice for introducing radiopharmaceuticals for clinical use. IAEA-Tecdoc-1782. Vienna: International Atomic Energy Agency;;ISSN 1011-4289;1782

Loveless, V. (2009). Quality control of compounded radiopharmaceuticals, continuing education for Nuclear pharmacist and Nuclear Medicine Professionals. University of New Mexico Health Sciences Center, College of Pharmacy,; 15 (XV), Lesson 3, p 9-12

Millar, A.M., Beattie, L.A., Craig, F., & O’Brien, L.M. (2009). An evaluation of GMCP-SA as a replacement for ITLC-SG when measuring the levels of radiochemical impurities in 99m Tc-radiopharmaceuticals by thin-layer chromatography. Journal of Labelled Compounds and Radiopharmaceuticals 52:538- 542

Parisella, M.G., Chianelli, M., Alessandria, C.D. et al. (2012). Clinical indications to the use of 99mTc-EDDA/HYNIC-TOC to detect somatostatin receptor-positive neuroendocrine tumors. Q J Nucl Med Mol Imaging; 56: 90–98.

Saha, G.B. (2010). Fundamentals of Nuclear Pharmacy, 6th edition. New York: Springer; pp. 153-164

The United States Pharmacopeial Convention. V alidation of compendial procedures (general information 1225). The United State Pharmacopeia and National Formulary (UPS37-NF32). Rockville: The United State Pharmacopeia; 2008

TEKTROTYD, Kit for radiopharmaceutical preparation, DE/H/3726/001/DC, November 2015

Todde, S., Kolenc Peitl, P., Elsinga, P., Koziorowski, J., Ferrari, V., Ocak, E., et al. (2017). Guidance on validation and quantification of processes and operations involving radiopharmaceuticals. European Journal of Nuclear Medicine and Molecular Imaging Radiopharmacy and Chemistry 2:8

Todde, S., Windhorst, A.D., Behe, M., Bormans, G., Decristoforo, C., Faivre-Chauvet, A., et al. (2014). EANM guideline for preparation of an investigational medicinal product dossier (IMPD). European Journal of Nuclear Medicine and Molecular Imaging;41:2175-2185

Vincenti, L.P., Samuel, A., & Zarf, F. (2016). Establishing radiopharmaceutical standards at a Nuclear Medicine unit in Malta. International Journal of Radiology and Imaging Technology;2:012




How to Cite

Jashari, A., Grozdanovska, J., Kaçiu, Y., Makraduli, L., Adzi-Andov, L., & Janevik-Ivanovska, E. (2021). COST-EFFECTIVE QUALITY CONTROL METHOD FOR RADIOCHEMICAL PURITY OF 99mTC-TECTROTYD USED IN A HOSPITAL RADIOPHARMACY UNIT. KNOWLEDGE - International Journal , 49(4), 731–737. Retrieved from

Most read articles by the same author(s)