APR January/February 2022 - 43

« INSTRUMENTATION
European Pharmacopoeia
Approach to Testing
for Pyrogenicity
Emmanuelle Charton, PhD
Head of Division B, European Pharmacopoeia Department, European Directorate for the
Quality of Medicines & HealthCare (EDQM)
Council of Europe, Strasbourg, France
Introduction
The texts of the European Pharmacopoeia (Ph. Eur.) play a major role
in ensuring the quality of medicines in Europe. They consist in general
chapters and monographs, which are mandatory quality standards
ubiquitously applied by the licencing authorities of the 39 signatory
countries of the European Pharmacopoeia Convention and the
European Union, with the overall aim of protecting public health. The
European Pharmacopoeia Commission, the decision-making body
of the Ph. Eur., is responsible for the elaboration and maintenance
of its content. The European Directorate for the Quality of Medicines
& HealthCare (EDQM) is a directorate of the Council of Europe and is
entrusted with publishing the Ph. Eur. and bringing these standards
to its users.
It goes without saying that any official standards dealing with the
quality of medicines must address the issue of potential contaminants
in the products concerned. Medicinal products contaminated with
pyrogenic substances and administered parenterally may cause
adverse reactions ranging from fever to life-threatening shock-like
symptoms. The aim of pyrogenicity testing is to limit, to acceptable
levels, the risk of these adverse reactions happening.
In the Ph. Eur., medicinal products are tested for pyrogenic substances
according to general chapter 2.6.8. Pyrogens. The test consists of
measuring the rise in body temperature induced in rabbits by the
intravenous injection of a sterile solution of the substance to be
examined. The chapter was first published in the Ph. Eur. in 1971 and is
still prescribed in a large number of monographs and general chapters.
Endotoxins from gram-negative bacteria (lipopolysaccharides) are the
most common cause of pyrogenic reactions induced by contaminated
pharmaceutical products. The level of bacterial endotoxins is verified
using the procedures described in Ph. Eur. general chapters 2.6.14.
Bacterial endotoxins or 2.6.32. Test for bacterial endotoxins using
recombinant factor C, published for the first time, respectively in
1987 and 2020. These are the analytical methods most commonly
used to address the pyrogenicity of medicinal products administered
parenterally. They present the great advantage of avoiding the use of
laboratory animals but the drawback of not detecting fever-inducing
substances other than bacterial endotoxins.
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APR January/February 2022

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