Open AccessMethodology for Calculating Bacterial Endotoxin Limits
Author(s) -
O. V. Shapovalova,
Н. П. Неугодова
Publication year - 2022
Publication title -
vedomosti naučnogo centra èkspertizy sredstv medicinskogo primeneniâ
Language(s) - English
Resource type - Journals
eISSN - 2619-1172
pISSN - 1991-2919
DOI - 10.30895/1991-2919-2022-12-1-110-111
Subject(s) - christian ministry , russian federation , limit (mathematics) , selection (genetic algorithm) , product (mathematics) , risk analysis (engineering) , business , computer science , mathematics , political science , machine learning , law , mathematical analysis , geometry , economic policy
Product specification files for parenteral medicines, as well as for active ingredients used in their production, have to include the “Bacterial endotoxins” parameter that controls the content of pyrogenic impurities. The experts of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation proposed recommendations for calculation and selection of the bacterial endotoxin limit, which will help applicants to include correct requirements for bacterial endotoxin limits in their product specification files. The proposed algorithm for the selection of bacterial endotoxin limits will make it possible to reduce the risk of pyrogenic reactions in patients and ensure safe use of medicinal products.