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USP

Fondaparinux sodium System Suitability Mixture B

United States Pharmacopeia (USP) Reference Standard

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About This Item

Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24
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Qualité

pharmaceutical primary standard

Famille d'API

fondaparinux

Forme

powder

Fabricant/nom de marque

USP

Application(s)

pharmaceutical (small molecule)

Format

mixture

Température de stockage

−20°C

Catégories apparentées

Description générale

The Fondaparinux Sodium System Suitability Mixture B is a USP reference mixture comprising structurally related oligosaccharide components. It is used to verify the performance of chromatographic systems used for analyzing fondaparinux sodium and related substances. It ensures method reproducibility and system adequacy.

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

Fondaparinux sodium System Suitability Mixture B USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monograph such as Fondaparinux Sodium Injection.

Remarque sur l'analyse

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Autres remarques

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

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable

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