Pharmacopoeial Requirements and Bacterial Contaminants

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.

Endotoxins and pyrogens may be present in sterile products as a by-product of the sterilization process.

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.

<p>Injecting sufficient quantities of endotoxins and pyrogens can cause fever and even shock.</p> Signup and view all the answers

<p>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.</p> Signup and view all the answers