1282730

Fondaparinuxnatrium-Systemeignungsmischung B

United States Pharmacopeia (USP) Reference Standard

• NACRES: NA.24
• UNSPSC Code: 41116107

Eigenschaften

• grade: pharmaceutical primary standard
• agency: USP
• API family: fondaparinux
• form: powder
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule)
• format: mixture
• storage temp.: −20°C

Beschreibung

General description

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-Natrium Der USP-Referenzstandard System Suitability Mixture B ist zur Verwendung für die in den USP-Kompendien spezifizierten Qualitätsprüfungen und Assays vorgesehen. Er dient auch zur Verwendung mit USP-Monografien wie für Fondaparinux-Natrium zur Injektion.

Analysis Note

Diese Produkte sind ausschließlich zur Verwendung in Tests und Assays vorgesehen. Sie sind nicht für die Verabreichung an Menschen oder Tiere bestimmt und dürfen nicht zur Diagnose, Behandlung oder Heilung von Krankheiten irgendwelcher Art verwendet werden.​

Other Notes

Dieses Produkt ist Teil des USP-Biologics-Programms.

Ggf. sind Verkaufsbeschränkungen zu beachten.

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.

Sicherheitshinweise

• Lagerklasse: 11 - Combustible Solids
• flash_point_f: Not applicable
• flash_point_c: Not applicable