REAGENTS AND TEST SOLUTIONS
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 β-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.]
▲Recombinant Reagent (rF)
A lyophilized product obtained from the in vitro culture of the C factor protein (the first protein in the horseshoe crab endotoxin reactive cascade) or the three cascade proteins (cloned from any of the following horseshoe crab genera: Limulus, Tachypleus, or Carcinoscorpius. Because the G factor is not part of the rF formulations, there is no need to use a glucan-blocking reagent. Where the recombinant reagent contains only the C factor, because this is an endpoint fluorometric reaction, the use of this reagent will also require the use of a qualified fluorometer with the appropriate software. The assurance of quality and performance of the rF reagents rests with the user.▲ (USP 1-Dec-2020)
Source from USP and Please refer to USP for details:
plastic pharmaceutical packaging
Copyright © Shijiazhuang Xinfuda Medical Packaging Co., Ltd. All Rights
MAKE AN ENQUIRY
