USP General Chapter

<210> Monosaccharide Analysis

The glycan composition of therapeutic glycoproteins may impact the biological activity, stability, pharmacokinetics, pharmacodynamics, efficacy, and immunogenicity of the molecule. The glycosylation pattern, or specific aspects of it such as the degree of sialylation, may form part of the product characterization and release specifications. Read this chapter to learn methods used to the consistency of glycosylation and compliance of the product with specifications.

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