1282730

Idoneità del sistema Fondaparinux sodio Miscela B

United States Pharmacopeia (USP) Reference Standard

• NACRES: NA.24
• UNSPSC Code: 41116107

Proprietà

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

Descrizione

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 sodio miscela B idoneità del sistema standard di riferimento USP, per uso in test e saggi di qualità specificati secondo quanto dettagliato nei relativi compendi USP. Da utilizzare anche con monografie USP quali Fondaparinux sodio iniezione.

Analysis Note

Questi prodotti sono destinati esclusivamente a prove sperimentali e analisi. Non possono essere somministrati a persone o animali e non possono essere usati come mezzi per diagnosticare, trattare e curare malattie di alcun genere.  ​

Other Notes

Le vendite potrebbero essere soggette a restrizioni.

Questo prodotto è parte del programma USP Biologics

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.

Informazioni sulla sicurezza

• Classe di stoccaggio: 11 - Combustible Solids
• flash_point_f: Not applicable
• flash_point_c: Not applicable