1235503

Endotoxin

United States Pharmacopeia (USP) Reference Standard

• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

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

Description

General description

Endotoxins are lipopolysaccharides located in the outer membrane of Gram-negative bacteria. They are potent pyrogens and can elicit strong immune responses, making their detection and quantification essential in pharmaceutical and medical device manufacturing to prevent adverse patient reactions.​

The USP Endotoxin standard provides a benchmark for the detection and quantification of bacterial endotoxins.

The USP biologics carbohydrates category includes a variety of carbohydrate-based substances that are essential in the development and manufacturing of therapeutic products. These carbohydrates play crucial roles in biological processes and are often utilized as excipients, stabilizers, or active ingredients in pharmaceuticals. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of carbohydrate therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

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