To make sure injectable drugs are safe and effective, manufacturers are required to conduct several tests before selling them. They should check if the drug contains the compound it claims to contain, and has the correct amount. Other tests include inspection of the clarity of the liquid, and a test to ensure that the drug’s impurities are within limits. Together, these tests are called ‘quality specifications’.
The two most important specifications for injectable drugs are that they must be sterile and contain a limited amount of bacterial endotoxin. Sterile means that the drug contains no live microbes, whereas endotoxins are toxins released by these microbes.
Endotoxins released by Gram-negative bacteria are particularly dangerous to humans, as they can cause septic shock and kill patients. This is a particularly worrisome problem for injection because these drugs enter the bloodstream directly, bypassing the gastric system. The gastric system has developed certain mechanisms to fight these contaminants. But when germs and toxins enter the bloodstream, where fewer such barriers exist, contaminants can quickly become fatal.
For this reason, a treatise called the Pharmacopoeia, which mandates quality standards for all drugs sold in a particular country, must contain sterility and bacterial endotoxin testing for all injections.
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