5 Questions
What are endotoxins and pyrogens?
Endotoxins and pyrogens are bacterial products released from live bacteria or after they die. They must be practically free from endotoxins and pyrogens in sterile products.
Why may endotoxins and pyrogens be present in sterile products?
Endotoxins and pyrogens may be present in sterile products as a by-product of the sterilization process.
What are particulates and why are they important in intravenous administration?
Particulates are visible or subvisible particles. They must comply with a particulate contamination test and be free of visible particles and contain only very low numbers of subvisible particles. Particulates are particularly important in intravenous administration as they may result in embolism.
What are the potential consequences of injecting sufficient quantities of endotoxins and pyrogens?
Injecting sufficient quantities of endotoxins and pyrogens can cause fever and even shock.
What are the pharmacopoeial requirements for particulates in injectable products?
The European Pharmacopoeia sets limits on the number of 10 µm and 25 µm particles per container of injectable product. However, these standards are not appropriate for suspensions or emulsions. For emulsions, the maximum droplet size will be linked to capillary diameter and droplet size must usually be less than 3 µm in diameter to prevent oil embolisms.
Test your knowledge on the pharmacopoeial requirements for parenteral drug delivery and the presence of endotoxins and pyrogens. Learn about the potential risks associated with these bacterial products and the importance of complying with the test for bacterial endotoxins.
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