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doi: 10.1016/j.cbi.2019.06.001 186 SallesGNCalioMLHolscherCPacheco-SoaresCPorcionattoMLoboAO
HPLC purity, LC-MS identity, ICP-based copper content, and LAL endotoxin readings are scored against pre-locked specifications, and full pass across all four assays is required before any vial clears into saleable inventory
Rather, it reflects the evidence available, how the compound is manufactured and distributed, and whether regulators believe it should be available through established medical channels
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