Endotoxin

Description

• General description: Endotoxin, present in Gram-negative bacteria, is a pyrogenic substance. Its ability to form stable interactions with other biomolecules makes it challenging to remove, particularly during the manufacturing of biopharmaceutical drugs. Endotoxin primarily comprises O-antigen, core polysaccharide, and lipid A components.[1]Suitable for Bacterial Endotoxins Test (BET) - a test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). BET comprises three tests:the gel-clot techniquethe turbidimetric techniquethe chromogenic technique[2]Endotoxin USP reference standard is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets, have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.
• Application: Endotoxin USP reference standard is intended for use in specified quality tests and assays as specified in the USP compendia. It is also used in the:Characteristics analysis of an endotoxin according to the United States Pharmacopeia (USP) monograph “Endotoxin Indicator for Depyrogenation”.Preparation of standard solutions during preparatory testing for the confirmation of labeled lysate sensitivity according to the United States Pharmacopeia (USP) general chapter.[2]Based directly on official monographs published in the USP-NF, these highly characterized physical specimens are used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality, and purity of peptide-based medicines.Further information is available in the monograph, Endotoxin Indicator for Depyrogenation, USP43-NF38 - 1621 of the USP (United States Pharmacopeia).
• Other Notes: This product is part of the USP Biologics program.