1235503

Endotoxin

10,000 USP Endotoxin Units, United States Pharmacopeia (USP) Reference Standard

• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat

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.
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 technique
• the turbidimetric technique
• the chromogenic technique

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

Also, for use with USP monographs such as:

• Endotoxin Indicator for Depyrogenation
• Gallium Citrate Ga 67 Injection
• Sodium Iodide I 131 Solution
• Technetium Tc 99m Succimer Injection
• Yttrium Y 90 Ibritumomab Tiuxetan Injection
• Iothalamate Sodium I 125 Injection

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.
• 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.

Sales restrictions may apply.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable