N -乙酰神经氨酸

N-Acetylneuraminic acid (Neu5Ac) is the most abundant sialic acid found on the terminal positions of glycan chains in glycoproteins and glycolipids. It plays a critical role in cell signaling and pathogen recognition. The USP standard supports identification and quantitation in glycosylation analysis of biopharmaceuticals.

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.

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