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They can legally produce peptide medications only when there is a documented medical need such as a shortage of the brand-name version, and they must follow strict sourcing and quality standards

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A complete Certificate of Analysis should show an HPLC result with a single dominant peak at the stated purity, a mass-spectrometry result confirming the molecular weight matches the intended compound, a bacterial endotoxin result from the Limulus Amebocyte Lysate (LAL) assay, the batch or lot number, and the name of an independent testing laboratory with a recent date