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1235503

USP

内毒素

United States Pharmacopeia (USP) Reference Standard

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1 VIAL
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About This Item

UNSPSC代码:
41116107
NACRES:
NA.24

$586.00


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等级

pharmaceutical primary standard

制造商/商品名称

USP

应用

pharmaceutical (small molecule)

包装形式

neat

一般描述

内毒素存在于革兰氏阴性菌中,是一种热原物质。由于会和其他生物分子稳定互作而难以去除,特别会造成生物药物生产的不便。内毒素主要是由O-特异性抗原多糖、核心多糖、类脂A三部分组成。[1]
适用于细菌内毒素试验(BET),该试验采用鲎(美洲鲎中华鲎)变形细胞裂解物(鲎试剂)检测或定量革兰氏阴性菌的内毒素。细菌内毒素试验有三种方法:

  • 凝胶法
  • 浊度法
  • 显色法[2]
内毒素(USP标准品)的规格和详细说明如药典颁发机构所示。所有为支持本产品而提供的信息,包括MSDS和任何产品信息单均在药典颁发机构授权下制定并发布。如需进一步信息和支持,请访问现行药典网站。

应用

内毒素USP参考标准品设计用于USP规定的指定质量测试和检测。其他用途:

  • 按美国药典专论《去热原用内毒素指示剂》所示,用于内毒素的特性分析。
  • 按照美国药典通则所示,在确认标记裂解物灵敏度的预试验中,用于制备标准溶液。[2]
  • 按USP-NF官方专论所示,在医药及相关行业中,这种高度表征的标准品可用于肽类药物的ID、强度、质量和纯度的测试。
更多信息请参阅美国药典(USP)《去热原用内毒素指示剂》专论(USP43-NF38 - 1621)。
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

其他说明

该产品是美国药典生物制品计划的一部分。
可能适用相应的销售限制条件。

储存分类代码

11 - Combustible Solids

WGK

WGK 2

闪点(°F)

Not applicable

闪点(°C)

Not applicable


历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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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)
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)
Bacterial Endotoxins Test
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 45(5), 6508-6508 (2018)

相关内容

提供适用USP-NF各论的全面标化的一级标准物质,可用于检验药物成分和剂型、药用辅料、食品和膳食补充剂。

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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