Dalteparin sodium

Dalteparin sodium is a low molecular weight heparin (LMWH) derived from porcine intestinal mucosa. It exerts antithrombotic activity primarily by enhancing antithrombin III-mediated inhibition of Factor Xa. The USP reference standard supports identity and potency assays in LMWH formulations through chromatographic and bioanalytical methods.

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.