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GenScript ToxinSensor™ Gel Clot Endotoxin Assay Kit is designed as a simple and sensitive in vitro end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. The LAL test is a qualitative test for Gram-negative bacterial endotoxin. Lyophilized Amebocyte Lysate as supplied in the kit is to be reconstituted with LAL Reagent Water and then mixed in equal parts with the solution being tested.

Description

GenScript ToxinSensor™ Gel Clot Endotoxin Assay Kit is designed as a simple and sensitive in vitro end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. The LAL test is a qualitative test for Gram-negative bacterial endotoxin. Lyophilized Amebocyte Lysate as supplied in the kit is to be reconstituted with LAL Reagent Water and then mixed in equal parts with the solution being tested. After incubation, and in the presence of endotoxin, gelation occurs; in the absence of endotoxin, gelation does not occur. Lyophilized Amebocyte Lysate reagent is made from amebocyte lysate from the horseshoe crab (Tachypleus tridentatus).The protocol described herein conforms to those described in the FDA guideline. Similar performance requirements for gel clot assays have been published and are updated regularly in the United States Pharmacopeia.

Note

For specimen preparation, the specimen should be certified free of Beta Glucans contaminant which may come from yeast and cellulosic materials, such as blood products.

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