When bacteria die or autolysis, they release endotoxin, and bacterial endotoxin is widespread in the environment. Endotoxin is not a protein, a complex of carbohydrates and lipids, so it is very heat-resistant: heating at 100 C for 1 hours will not be destroyed, only at 160 C for 2 to 4 hours at the temperature, or strong alkali, or strong. An acid or a strong oxidizer is boiling for 30 minutes to destroy its biological activity. Unlike the exotoxin, the endotoxin can not be detoxated to a toxoid by dilute formaldehyde and other solvents. It will only degrade into smaller substances and still have pyrogen. Therefore, the removal of the injectable excipient is very difficult to be contaminated by endotoxin. It can be seen that the control of microorganism and endotoxin is particularly important in the production process of excipients.
Shandong Binzhou Zhiyuan Biotechnology is a manufacture of cyclodextrin . The main products is : hydroxypropyl betadex and betadex sulfobutyl ether sodium ,we have cleaning room and the products be produced accordance with GMP standard .