Pyrogens endotoxins

Endotoxins Pyrogens, LAL Testing, and Depyrogenation, Second Edition, Revised and Expanded, Kevin L. Williams... 

US FDA, ITG subject bacterial endotoxins/pyrogens. In Office of Regulatory Affairs (Ed.), Inspector s Technical Guide, Washington, DC, 1987. 

Small-Volume Parenterals Color, clarity of solutions, particulate matter, pH, sterility, endotoxins. Powders for injection solutions include clarity, color, reconstitution time and water content, pH, sterility, endotoxins/pyrogens, and particulate matter. Suspensions for injection should include additional particle size distribution, redispersability, and rheological properties. Emulsion for injection should include phase separation, viscosity, mean size, and distribution of dispersed globules. 

Various enzymes, lysozyme, catalase, phosphatase, malate/formate dehydrogenase, adenylase kinase, pymvate decarboxylase, alkaline phospatase, serum albumin, lipoprotein, interferon, growth factor, polypeptide hormone DNA, RNA, y-globulin, proteinase, carboxypeptidase, endotoxins, pyrogen, IgG, trypsin inhibitor, transferrin, casein, L-benzoyl arginine ethyl ester, cytocrome C IgG, heparin... 

Endotoxin pyrogen induces fever by an indirect process. On entry into the circulatory system, endotoxin is bound to LPS-binding protein (LPB) that transports it to receptor cells in the reticuloendothelial system. The main target cells are circulating mononuclear cells, which produce proinflammatory cytokines such as interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor-a (TNFot). These cytokines are involved in acute and chronic inflammation, induce fever, and modulate the host s response to bacterial infection. ° ... 

As confidence grew in the capability of the LAL test, as a screening tool for endotoxin pyrogen, pharmaceutical and medical device industries began to replace the rabbit test with the new in vitro test. The USP has continually revised the BET to keep abreast of advancements in LAL methodology. 

Sweadner, K.J. Forte, M. Nelson, L. Filtration removal of endotoxin (Pyrogens) in solution in different states of aggregation. Appl. Environ. Microbiol. 1977, 34, 382-385. 

Cooper, J.F. Hochstein, D.H. Seligmann, E.B. The limulus test for endotoxin (Pyrogen) in radiopharmaceuticals and biologicals. Bull. Parent. Drug Assoc. 1972, 26, 153-162. 

Endotoxins Pyrogens, LAL Testing and Depyrogenation, Third Edition... 

Chemical Biological Endotoxin (Pyrogen) Navy shipboard Sulfolobus... 

Its applications now include water treatment, food processing, biotechnology and chemicals processing. UF is used for removing macromolecules, coUoids, coUoidal sihca, emulsified oil, endotoxins, pyrogens, viruses and bacteria. 

Lee PS. Limulus Ameboc5h e Lysate testing of medical devices. In Williams KL, editor. Endotoxins Pyrogens, LAL testing and depyrogenation. 2007. p. 366. 

According to the Ph. Eur. parenteral preparations should be sterile, free from visible and non-visible particles and free from endotoxins/pyrogens (see Sect. 12.8). 

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