title: U.S. Government quality control program for Limulus amebocyte lysate and endotoxin.
abstract: The U.S. Government has licensed seven Limulus Amebocyte Lysate manufacturers. Each manufacturer must determine the sensitivity of each lot by using the U.S. Standard Endotoxin, EC-5 which is identical to the U.S. Pharmacopeia (USP) Endotoxin Standard (Lot F). A licensed firm must be inspected annually and submit a protocol along with potency testing results on each lot of lysate before it can be released. The FDA tests each lot for at least potency before releasing it to be marketed. The release criteria for both the gelation and chromogenic lysate tests are discussed.
mesh_terms: D002863:Chromogenic Compounds; D004731:Endotoxins / Q000032:analysis*; D008033:Limulus Test; D011786:Quality Control; D014481:United States
chemical_list: D002863:Chromogenic Compounds; D004731:Endotoxins