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Such data are lacking for most of these peptides Scott Brunner Therefore, the FDA will have to look at this issue from a different angle. Therefore, the FDA will have to look at this issue from a different angle. Scott Brunner Placement on the 503A Bulks List is not an approval of the drug, but a regulatory question: does the peptide meet certain criteria so that pharmacies can prepare it from bulk ingredients under a patients prescription

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If this occurs: Allow additional time at room temperature (up to 30 minutes total) Very brief, gentle vortexing (35 seconds) as a last resort If aggregation persists, consider re-solubilizing in 10 mM HCl at a slightly lower concentration 6

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