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Mineral Salts Low in Endotoxins for Pharmaceutical Applications
Endotoxins or pyrogens are lipopolysaccharides – outer membrane components of gram-negative bacteria. During decomposition or metabolism, these bacteria release lipopolysaccharides, which are toxic. Parenteral-induced quantities as low as 0.1ng/kg of bodyweight can cause various immune reactions, including fever, inflammation and sickness in humans and animals.
Moreover, endotoxins can cause undesirable effects on cell proliferation or cell function for biopharmaceutical fermentation and purification processes.
To avoid this, the manufacture of products for parenteral administration requires particular caution; it is subject to specific regulatory requirements and is regulated by chapter 2.6.14 of the European Pharmacopoeia (Ph.Eur).
Dr. Paul Lohmann’s state-of-the-art production unit allows a manufacturer to comply with quality and regulatory requirements by a Quality by Design (QbD) approach. The dedicated purpose built plant is GMP certified and LAL tests according to Ph.Eur are performed on each batch. Customers can seamlessly integrate Dr. Paul Lohmann® products, which are Low in Endotoxins, into their process chain for the manufacture of parenteral dosage forms.
Low-endotoxin mineral compounds can be used for the production of two pharmaceutical forms and routes of administration:
Parenteral: intravenous, intra-arterial, intramuscular and subcutaneous
Dialysis: peritoneal dialysis, haemofiltration and osmotherapy
Dr. Paul Lohmann® offer Low in Endotoxin qualities for the following broad product lines:
Acetates | Aspartates | Citrates | EDTAs | Glycerophosphates | Gluconates | Lactates | Phosphates | Succinates | Sulfates
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