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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

UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical primary standard

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

Související kategorie

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.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Osvědčení o analýze (COA)

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Navštívit knihovnu dokumentů

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

Související obsah

USP Compendial Reference Standards

Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.

Referenční standardy USP Compendial

Objednejte si ze široké nabídky vysoce charakterizovaných primárních referenčních standardních materiálů pro použití s monografiemi USP-NF pro testování léčivých látek a lékových forem, farmaceutických pomocných látek, složek potravin a doplňků stravy.

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