The purity of a mineral salt is a decisive criterion for its quality. By conforming to the very highest in-house quality standards, which far surpass the minimum requirements of international pharmacopoeias, we ensure that only the purest mono- or defined multi-constituent substances leave our factory.
But we do not restrict ourselves to chemical purity alone. In particular for mineral salts for medicinal purposes, we impose additional, stringent requirements regarding biological purity.
We meet these by producing especially low-endotoxin grades for parenteral use.
What are endotoxins?
Endotoxins are found in the cell membrane of gram-negative bacteria. more
Endotoxins are found in the cell membrane of gram-negative bacteria. Endotoxic lipopolysaccharides are for example released when bacteria die, and primarily bind with the cell membrane of macrophages, which are part of the immune system. These subsequently produce inflammatory mediators, which can trigger symptoms such as fever. In addition, there may be an influence on blood clotting, whereby the resulting release of bradykinin can result in vasodilation or even septic shock33.
Just minute quantities of endotoxins can suffice to trigger a response of this nature. A mere 0.1 ng per kilogram of bodyweight can provoke fever34.
Low-endotoxin mineral salts for medicinal applications
The manufacture of low-endotoxin products is subject to special requirements more
The manufacture of low-endotoxin products is subject to special requirements from both the current European Pharmacopoeia (Ph. Eur. sections 2.6.8 and 2.6.1435) and the relevant EU Directive36. In order to satisfy these and our own stringent requirements regarding the biological purity of our products, we manufacture our low-endotoxin grades in a production system specially designed for this purpose. The mineral salts synthesized in this way can be used in the following areas:
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