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1235503

USP

Endotoxin

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

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About This Item

Código UNSPSC:
41116107
NACRES:
NA.24

grado

pharmaceutical primary standard

fabricante / nombre comercial

USP

aplicaciones

pharmaceutical (small molecule)

formato

neat

Categorías relacionadas

Descripción general

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.

Aplicación

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).

Otras notas

This product is part of the USP Biologics program.
Sales restrictions may apply.

Código de clase de almacenamiento

11 - Combustible Solids

Clase de riesgo para el agua (WGK)

WGK 2

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Visite la Librería de documentos

Endotoxin Indicator for Depyrogenation
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 34(6), 1621-1621 (2013)
Bacterial Endotoxins Test
USP43-NF38-6508: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 45(5) (2018)
Bacterial Endotoxins Test
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 45(5), 6508-6508 (2018)
Current trends in endotoxin detection and analysis of endotoxin-protein interactions
Critical Reviews in Biotechnology (2017)
Endotoxin Indicator for Depyrogenation
USP43-NF38 - 1621:United States Pharmacopeia and National Formulary
United States Pharmacopeia, 34(6) (2013)

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