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Regulatory agencies now mandate rigorous lot-to-lot consistency, requiring detailed physicochemical fingerprints that include particle size, polydispersity, ligand stoichiometry, residual solvent levels, and bioactivity, thus necessitating GMP-grade precision at scale [494,495,496]

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Nargesi A, Adejumo P, Dhingra L, Rosand B, Hengartner A, Coppi A, Benigeri S, Sen S, Ahmad T, Nadkarni G, Lin Z, Ahmad F, Krumholz H , Khera R