Pyrogen is also called endotoxin, and it comes from the external wall of gram-negative bacteria, which is the fragment of bacterial corpses. It is a kind of lipopolysaccharide substance whose relative molecular mass varies from several thousands to hundreds of thousands, and it is determined by the types of bacteria that produce it. In aqueous solutions, the relative molecular mass varies from hundreds of thousands to millions.
If trace pyrogen mixed into the medicament is injected to human hematological system, it will cause severe fever, and even death. Therefore, it is necessary to reduce the content of pyrogen in liquid as much as possible, and especially when the dosage of injection (such as large volume injections) is large, the concentration of pyrogen should be stricter.
The liquid for injection pyrogen removal (or water for injection) should be in line with the testing and regulations of pharmacopoeia and it is a basic production link in pharmaceutical industry. At present, the general methods of introducing pyrogen removal include the following 3 categories:
1. Distillation method is used to produce pyrogen removal water, which is used as injection water and washing water with higher costs.
2. Adsorption method is used to remove pyrogen. The first way is that surface adsorbents adsorb thermogenic substances, so that product substances can pass through. The second way is that adsorbents adsorb product substances, so that the pyrogen flows out and then product substances can be analyzed and recycled from adsorbent surface. The substances that can be silicon mud, activated carbon and ion exchange resin, and asbestos are not allowed to be adsorbents.
3. As a new process and technology, membrane separation method is widely popularized and applied in pharmaceutical industry. The principle of ultrafiltration pyrogen removal is the use of ultrafiltration membrane intercepting pyrogen which is less than the pyrogen molecular weight, and this method has been certified by Food and Drug Administration with the advantages of small labor intensity, high product yield and good product quality.
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