Fondaparinux sodium System Suitability Mixture B

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.