Amoebocyte Lysate— A lyophilized product obtained from the lysate of amoebocytes (white blood cells) from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). This reagent refers only to a product manufactured in accordance with the regulations of the competent authority. [note—Amoebocyte Lysate reacts to some -glucans in addition to endotoxins. Amoebocyte Lysate preparations that do not react to glucans are available: they are prepared by removing the G factor reacting to glucans from Amoebocyte Lysate or by inhibiting the G factor reacting system of Amoebocyte Lysate and may be used for endotoxin testing in the presence of glucans. ]
Water for Bacterial Endotoxins Test (BET)— Use Water for Injection or water produced by other procedures that shows no reaction with the lysate employed, at the detection limit of the reagent.
Lysate TS— Dissolve Amoebocyte Lysate in Water for BET, or in a buffer recommended by the lysate manufacturer, by gentle stirring. Store the reconstituted lysate, refrigerated or frozen, according to the specifications of the manufacturer.