Pyrogen Testing in Pharmaceutical Industry
Pyrogen testing is important in the pharmaceutical industry because it detects the presence of pyrogens, which are substances that can cause fever.
Pyrogens can contaminate pharmaceutical products during the manufacturing process and can cause serious health problems if they enter the body.
Pyrogen testing helps to ensure the safety and quality of pharmaceutical products by detecting the presence of pyrogens and preventing their release into the market.
The USP pyrogen test is a widely used method for detecting pyrogens, but it has some limitations, such as being time-consuming and requiring a large number of animals.
The Bacterial Endotoxins Test (BET), also known as the Limulus Amebocyte Lysate (LAL) test, is a more sensitive and specific method that is widely used in the pharmaceutical industry. The BET is used to detect the presence of endotoxins, which are a type of pyrogen that is produced by gram-negative bacteria.
The test is important because it helps to ensure the safety and quality of pharmaceutical products, and it is used to detect the presence of endotoxins in a wide range of products, including injectables, medical devices, and raw materials.
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