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Both catechin and epicatechin can undergo bioconversion yielding, e.g., 5-(3,4-dihydroxyphenyl)--valerolactone, by the metabolic reactions of Eggerthelia lenta and Adlercreutzia equolifaciens species, followed by activities of Flavonifractor plautii strains (80, 81)

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As one guidance slide succinctly states, one must identify each peptide-related impurity at level 0.10% and ensure no significant new impurity is introduced

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They arrived at a range of exponents between 0.22 and 0.35 and settled upon 0.294