Pyrogen is also called endotoxin, and it comes from the externa↕l wall of gram-negative bacteria, which is the fragment↑ of bacterial corpses. It is a kind of lipopolysaccharid×e substance whose relative molecular mass varies from several thousands to hundreds of thousa≠nds, and it is determined by the types of bacteria that proγduce it. In aqueous solutions, the relative molecular mass varies from hu∏ndreds of thousands to millions.
 

      If trace pyrogen mixed into the medicament is injected to human hematologicaΩl system, it will cause severe fever, and even death. Therefore, it is necessary to redu↔ce the content of pyrogen in liquid as much as possible, and especially when the dosage ofπ injection (such as large volume injections) is large, the concentration of pyrogen should be str'icter.

      The liquid for injection pyrogen removal (or water for →injection) should be in line with the testing and regulations of pharmacoαpoeia and it is a basic production link in pharmaceuβtical industry. At present, the general methods of introducing pyrogen removal in±clude the following 3 categories:

      1. Distillation method is used to produce pyrogen removal water, whiγch is used as injection water and washing water with higher costs.

      2. Adsorption method is used to r"emove pyrogen. The first way is that surface adsorbents adsorb thermogenic substances, so t>hat product substances can pass through. The second way¥ is that adsorbents adsorb product substances, so that the pyrogen flows out and t₽hen product substances can be analyzed and recycled from adsorbent surface. ∞The substances that can be silicon mud, activated carbon and ion exchange res↓in, and asbestos are not allowed to be adsorbents.

      3. As a new process and technology, membrane separation method is wi♣dely popularized and applied in pharmaceutical industry. The principle of ultrafiltration €pyrogen removal is the use of ultrafiltration membrane intercepting pyrogen which is le↕ss than the pyrogen molecular weight, and this method has been certified by Food and Drug Admini€stration with the advantages of small labor intensity, high product yield and good ∏product quality.

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