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/418/501/product-dating-information-06-25-mk.pdf
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| A ustedes/SKU | Disponibilidad | Precio |
|---|---|---|
1 vial | Póngase en contacto con nuestro Servicio de Atención al Cliente para disponibilidad | 483,00 € |
Acerca de este artículo
483,00 €
grade
pharmaceutical primary standard
agency
USP
form
lyophilized
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecule)
format
neat
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
- 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.
- 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
Other Notes
1 of 1
Este artículo | |||
|---|---|---|---|
| description United States Pharmacopeia (USP) Reference Standard | description BRP, European Pharmacopoeia (EP) Reference Standard | description United States Pharmacopeia (USP) Reference Standard | description United States Pharmacopeia (USP) Reference Standard |
| manufacturer/tradename USP | manufacturer/tradename EDQM | manufacturer/tradename USP | manufacturer/tradename USP |
| grade pharmaceutical primary standard | grade pharmaceutical primary standard | grade pharmaceutical primary standard | grade pharmaceutical primary standard |
| application(s) USP Biologics | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) |
| form lyophilized | form - | form - | form - |
| format neat | format neat | format neat | format neat |
| agency USP | agency - | agency USP | agency USP |
Clase de almacenamiento
11 - Combustible Solids
flash_point_f
Not applicable
flash_point_c
Not applicable
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How can I determine the shelf life / expiration / retest date of this product?
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How is shipping temperature determined? And how is it related to the product storage temperature?
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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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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 respuesta-
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.
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