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1235503

USP

Endotoxin

United States Pharmacopeia (USP) Reference Standard

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24
Pricing and availability is not currently available.

grade

pharmaceutical primary standard

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

Related Categories

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 technique
  • the turbidimetric technique
  • the 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

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.[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.
Sales restrictions may apply.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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Certificates of Analysis (COA)

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Bacterial Endotoxins Test
USP43-NF38-6508: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 45(5) (2018)
Endotoxin Indicator for Depyrogenation
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 34(6), 1621-1621 (2013)
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)
Bacterial Endotoxins Test
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 45(5), 6508-6508 (2018)

Related Content

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.

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.

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.

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.

Questions

1–3 of 3 Questions  

  1. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer

    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

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  2. How can I determine the shelf life / expiration / retest date of this product?

    1 answer

    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/449/386/product-dating-information-mk.pdf

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  3. Our lab is seeking to purchase purified endotoxin for our oxicity assays in mice. We would appreciate more information about this particular endotoxin 1235503-1VL, especially regarding its endotoxin units per milligram. Thanks

    1 answer

    1. The endotoxin content for each lot is available on the USP website or by contacting the regional technical service team. Only activity per vial is specified, not weight or concentration. This product is intended for laboratory testing according to various USP monographs and is not intended for in vivo studies.

      https://store.usp.org/product/1235503

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