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de Leeuw, E., Li, C., Zeng, P., Li, C., de Diepeveen, B.M., Lu, W.Y., et al., FEBS Lett

A solution that was clear at reconstitution but has become cloudy likely contains aggregated peptide

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Even where the agency accepts a recommendation, the substance is only added to the 503A list through formal notice-and-comment rulemaking