Methodology for Calculating Bacterial Endotoxin Limits

Abstract

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.

Keywords

• limit
• bacterial endotoxins
• pyrogenic dose
• maximum dose
• dosing regimen