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This ITG will center on the importance and interpretation of pyrogen/endotoxin testing. Also sources and methods of depyrogenation is going to be mentioned. The constraints of your rabbit pyrogen examination should be recognized when examining units in the course of inspections of sterile drug and product manufacturers.
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The USP's subcommittee responsible for revisions of compendial examination procedures and/or product monographs has, in the past few years, built some sizeable adjustments inside the bacterial endotoxin test and product monograph prerequisites. In 1984, five USP water goods got distinct bacterial endotoxin limits. Water for Injection, Sterile H2o for Injection and Sterile Water for Irrigation have an allowable endotoxin limit of 0.twenty five Endotoxin Units (EU)/ml.
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