Jurnal Farmasi Sains dan Komunitas
Vol 16, No 1 (2019)

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

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



Article Info

Publish Date
31 May 2019

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.

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Journal Info

Abbrev

JFSK

Publisher

Subject

Medicine & Pharmacology

Description

Jurnal Farmasi Sains dan Komunitas (Journal of Pharmaceutical Sciences and Community / J Pharm Sci Community) firstly published in 2003, is a peer-reviewed, open access scientific journal that publishes research articles, review articles, as well as short communication in various pharmaceutical ...