The European Pharmacopoeia (European Pharmacopoeia) is a single reference study for the quality control of drugs. Official standards published in it provide a legal and scientific basis for quality control in the development, production and marketing processes of medicines.
.jpg "Determination of Bacterial Endotoxins (European Pharmacopoeia 2.6.14 Bacterial Endotoxins)")
The European Pharmacopoeia 2.6.14 Bacterial endotoxin test, presented in the framework of the European Pharmacopoeia, is used to detect or quantify gram-negative bacterial endotoxins. Six methods are used for this test:
In case of any doubt or dispute, the final decision is made according to method A unless otherwise stated. The test is performed in a way that prevents endotoxin contamination.
Briefly, the bacterial endotoxin test is carried out to detect the toxic structures on the cell wall of gram-negative bacteria on the product. This parameter is strictly controlled in medical equipment in contact with the body, in the pharmaceutical industry and especially in dialysis waters.
In the test, analysis, measurement and evaluation studies carried out in our organization, national and international standards and applicable legal regulations are complied with and reliable and impartial results are obtained. These studies are based on the latest technological equipment, trained and experienced staff and modern methods. Among the numerous tests performed in this context, there are also bacterial endotoxin determination (European Pharmacopoeia 2.6.14 Bacterial endotoxins) services.
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