Determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital

Two different limulus amoebocyte lysate assays of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital are evaluated. The gel-clot LAL method and turbidimetric kinetic method were applied as techniques for determination of endotoxin from Gram – negative bac...

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Main Authors: Renata Bozhinovska Popovska, Tatjana Gjurichikj, Branislava Janeva, Jelena Acevska, Aneta Dimitrovska
Format: Article
Language:English
Published: University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association 2024-12-01
Series:Makedonsko Farmacevtski Bilten
Subjects:
Online Access:https://bulletin.mfd.org.mk/volumes/Volume%2070_1/70_1_007.pdf
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author Renata Bozhinovska Popovska
Tatjana Gjurichikj
Branislava Janeva
Jelena Acevska
Aneta Dimitrovska
author_facet Renata Bozhinovska Popovska
Tatjana Gjurichikj
Branislava Janeva
Jelena Acevska
Aneta Dimitrovska
author_sort Renata Bozhinovska Popovska
collection DOAJ
description Two different limulus amoebocyte lysate assays of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital are evaluated. The gel-clot LAL method and turbidimetric kinetic method were applied as techniques for determination of endotoxin from Gram – negative bacteria in a large volume of 0.9% NaCl solution for infusion. The same principle is applied but using different official methods for determination of bacterial endotoxin′s concertation. An overview of the advantages and disadvantages to the implementation of both methods is provided, with a detailed description of the procedures, comparison of the suitability of each method and recommendations based on the findings. The conventional gel-clot LAL method as a simple method can be recommended due to its economic sustainability in terms of equipment. On the other hand, the turbidimetric kinetic assay offers distinct advantages such as enhanced sensitivity, quantitative analysis capability, and instrumental reading. Furthermore, this method helps eliminate potential human variability in endpoint assessments. Therefore, the obtained results and critical aspects of the applied methods: the gel-clot LAL method and the turbidimetric kinetic method indicate that both LAL methods can be used for the determination of bacterial endotoxins in parenteral solutions, produced on a small scale and provide an opportunity for small laboratories to facilitate the decision – making process for choosing a method that best meets their requirements and resources.
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issn 1857-8969
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publisher University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association
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spelling doaj-art-a6cfca07a14a4a78997fad5d37df909d2025-01-11T13:40:29ZengUniversity Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical AssociationMakedonsko Farmacevtski Bilten1857-89692024-12-01701616810.33320/maced.pharm.bull.2024.70.01.007Determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospitalRenata Bozhinovska Popovska0Tatjana Gjurichikj1Branislava Janeva2Jelena Acevska3Aneta Dimitrovska4Clinic Hospital “dr. Trifun Panovski“, Partizanska bb, 7000 Bitola, R. North MacedoniaAlkaloid Ad, Blvd Aleksandar Makedonski No 12, 1000 Skopje, R. North MacedoniaPH – Institute for public health, 50 th division No 6, 1000 Skopje,R. North MacedoniaFaculty of Pharmacy, Ss Cyril Methodius University in Skopje, Majka Thereza 47, 1000 Skopje, R. North MacedoniaFaculty of Pharmacy, Ss Cyril Methodius University in Skopje, Majka Thereza 47, 1000 Skopje, R. North MacedoniaTwo different limulus amoebocyte lysate assays of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital are evaluated. The gel-clot LAL method and turbidimetric kinetic method were applied as techniques for determination of endotoxin from Gram – negative bacteria in a large volume of 0.9% NaCl solution for infusion. The same principle is applied but using different official methods for determination of bacterial endotoxin′s concertation. An overview of the advantages and disadvantages to the implementation of both methods is provided, with a detailed description of the procedures, comparison of the suitability of each method and recommendations based on the findings. The conventional gel-clot LAL method as a simple method can be recommended due to its economic sustainability in terms of equipment. On the other hand, the turbidimetric kinetic assay offers distinct advantages such as enhanced sensitivity, quantitative analysis capability, and instrumental reading. Furthermore, this method helps eliminate potential human variability in endpoint assessments. Therefore, the obtained results and critical aspects of the applied methods: the gel-clot LAL method and the turbidimetric kinetic method indicate that both LAL methods can be used for the determination of bacterial endotoxins in parenteral solutions, produced on a small scale and provide an opportunity for small laboratories to facilitate the decision – making process for choosing a method that best meets their requirements and resources. https://bulletin.mfd.org.mk/volumes/Volume%2070_1/70_1_007.pdfdetermination of bacterial endotoxinsgel-clot lal methodturbidimetric kinetic methodsmall scale production
spellingShingle Renata Bozhinovska Popovska
Tatjana Gjurichikj
Branislava Janeva
Jelena Acevska
Aneta Dimitrovska
Determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital
Makedonsko Farmacevtski Bilten
determination of bacterial endotoxins
gel-clot lal method
turbidimetric kinetic method
small scale production
title Determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital
title_full Determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital
title_fullStr Determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital
title_full_unstemmed Determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital
title_short Determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital
title_sort determination of bacterial endotoxins in parenteral solutions produced on a small scale in a clinical hospital
topic determination of bacterial endotoxins
gel-clot lal method
turbidimetric kinetic method
small scale production
url https://bulletin.mfd.org.mk/volumes/Volume%2070_1/70_1_007.pdf
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AT branislavajaneva determinationofbacterialendotoxinsinparenteralsolutionsproducedonasmallscaleinaclinicalhospital
AT jelenaacevska determinationofbacterialendotoxinsinparenteralsolutionsproducedonasmallscaleinaclinicalhospital
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