APPLICABILITY OF BACTERIAL ENDOTOXIN TEST (BET) FOR SOME RADIOPHARMACEUTICAL STERILE KITS BY THE USE OF TACHYPLEUS AMEBOCYTE LYSATE (TAL)

Amal Rezka Putra; Enny Lestari; Dede Kurniasih; Karyadi Karyadi; Endang Sarmini; Arni Aries

doi:10.24071/jpsc.001694

APPLICABILITY OF BACTERIAL ENDOTOXIN TEST (BET) FOR SOME RADIOPHARMACEUTICAL STERILE KITS BY THE USE OF TACHYPLEUS AMEBOCYTE LYSATE (TAL)

Amal Rezka Putra, Enny Lestari, Dede Kurniasih, Karyadi Karyadi, Endang Sarmini, Arni Aries

Abstract

The application of bacterial endotoxin test (BET) using TAL reagent on radiopharmaceutical kits is very important to conduct. The radiopharmaceutical kits that will be tested are macro aggregated albumin (MAA), tetrofosmin and ethambutol kits. Endotoxin testing stage was TAL 0.25 EU/mL verification test, inhibition/enhancement test, and endotoxin test for sample. Pyrogen testing using rabbits was also performed as a comparison test. The results of the TAL reagent verification test were all samples showed values corresponding to the standards of 2? = (+), 1? = (+), 1/2? = (-), 1/4? = (-), and negative water control (NWC) = (-). Furthermore, inhibition/enhancement tests for MAA, tetrofosmin, and ethambutol products show non-inhibiting or gel-inducing results, which are in accordance with acceptability standards, so that the samples can be tested using TAL reagents. The pH measurement results in each sample were MAA of 6.0, tetrofosmin of 7.0, and ethambutol of 8.0. The results of MAA, tetrofosmin, and ethambutol product testing were a sample = (-), positive product control (PPC) = (+), positive water control (PWC) = (+), and NWC = (-). In addition, the results of pyrogen testing also showed negative for MAA, tetrofosmin, and ethambutol.

Keywords

Bacterial endotoxin test (BET); Radiopharmaceutical kit; Tachypleus amoebocyte lysate (TAL)

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References

Bang, F. B., 1971. A factor in crab amebocytes which stimulates in vitro clotting of crab blood. Journal of Invertebrate Pathology, 18(2), 280283.

John, B.A., Kamaruzzaman, B.Y., Jalal, K.A., and Zaleha, K., 2012. TAL - a source of bacterial endotoxin detector in liquid biological samples. International Food Research Journal, 19(2), 423425.

Juwita, R., 2009. Biological evaluation of 99mTc-ethambutol for early detection of tuberculosis infection in animal model. Indonesian Journal of Pharmacy, 20(2), 5561.

Knapp, F. R. and Dash, A., 2016. Introduction: Radiopharmaceuticals Play an Role in Both Diagnostic and Therapeutic Nuclear Medicine, in Radiopharmaceuticals for Therapy. New York: Springer, 6.

Lestari, W., 2017. Formulation of Macroagregated Albumin (MAA) Kit for Lung Perfusion, in National Seminar on Nuclear Technology Utilization. 2017. Tangerang Selatan, 2732.

Li, H., Hitchins, V. M. and Wickramasekara, S., 2016. Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry. Analytica Chimica Acta, 943, 98105.

Lopes, I.G., Silva, C.C., Presgrave, O.A., and Bas, M.H, 2015. Assessment of pyrogenic response of lipoteichoic acid by the monocyte activation test and the rabbit pyrogen test. Regulatory Toxicology and Pharmacology, 73(1), 356360.

Miao, P., Han, K.W., Qi, J., Zhang, C., and Liu, T., 2013. Electrochemical investigation of endotoxin induced limulus amebocyte lysate gel-clot process. Electrochemistry Communications, 26(1), 2932.

Ochiai, M., Yamamoto, A.H., Naito, S., Maeyama, J., Masumi, A., Hamaguchi, I., Horiuchi, Y., and Yamaguchi, K., 2010. Applicability of bacterial endotoxins test to various blood products by the use of endotoxin-specific lysates. Biologicals, 38(6), 629636.

Salmanoglu, E., Kim, S. and Thakur, M. L., 2018. Currently Available Radiopharmaceuticals for Imaging Infection and the Holy Grail. Seminars in Nuclear Medicine. 2018. Elsevier Inc., 48(2), pp. 8699.

Sandle, T., 2016. Endotoxin and pyrogen testing, in Pharmaceutical Microbiology. 80th ed. Kidlington: Woodhead Publishing, 131145.

Scott, P. J. H. and Kilbourn, M. R., 2015. Radiochemical Syntheses, Volume 2: Further Radiopharmaceuticals for Positron Emission Tomography and New Strategies for Their Production. New Jersey: John Wiley & Sons, Inc.

Sharma, S., Mittal, B. R., Vatsa, R., and Singh, B, 2011. Gel clot bacterial endotoxin test of FDG: Indian scenario. Indian journal of nuclear medicine: the official journal of the Society of Nuclear Medicine, 26(3), 14952.

Silva D. C. C. Presgrave,O.A.F., Hartung, T., Moraes, A.M.L., and Delgado, I.F., 2016. Applicability of the Monocyte Activation Test (MAT) for hyperimmune sera in the routine of the quality control laboratory: Comparison with the Rabbit Pyrogen Test (RPT). Toxicology in Vitro, 32, 7075.

USP 35-NF 30 online version, 2012. United States, General Chapters/ Biological Tests and Assays <85> Bacterial Endotoxins Test. Available from: https://www.drugfuture.com/Pharmacopoeia/usp35/PDF/56255630%20%5b85%5d%20Bacterial%20Endotoxins%20Test.pdf. [Accessed January 1, 2019].

Widyastuti, W., Lestari, E. and Sangaji, D., 2017. Effect of Radioactivity of Technetium-99m on the Autosterilization Process of non-sterile Tetrofosmin Kits. The Journal of Pure and Applied Chemistry Research, 6(1), 5763.

The International Pharmacopoeia, Eight Edition, online version, 2018. New Zealand, Monoghraph: Technetium (99mTc) tetrofosmin complex injection (Technetii (99mTc) tetrofosmini multiplex injectio). Available from: https://apps.who.int/phint/pdf/b/6.3.2.24.Technetium-(99mTc)-tetrofosmin-complex-injection-(_.pdf [Accessed May 1, 2019].

Zandieh, M., Hosseini, S.N., Vossoughi, M., Khatami, M., Abbasian, S., and Moshaii, A., 2018. Label-free and simple detection of endotoxins using a sensitive LSPR biosensor based on silver nanocolumns. Analytical Biochemistry. Elsevier, 548 (February), 96101.

DOI: https://doi.org/10.24071/jpsc.001694