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Laddha NC, Chatterjee S, Gani AR, Malek RA, Shah BJ, Begum R
Staff cited inadequate substance characterization, uncertain product quality, insufficient evidence of effectiveness for ulcerative colitis, sparse human safety data, and unresolved risks such as immunogenicity, aggregation, impurities, and long-term exposure
The presence of even small amounts of an impurity can significantly alter a substance's melting behavior
If still not dissolving, the peptide may have degraded before reconstitution
& Dearing, D
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