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Peptide Reconstitution Steps Remove vial from -20C storage and equilibrate to room temperature for 15-30 minutes Calculate required solvent volume based on desired final concentration Select appropriate solvent based on peptide charge and hydrophobicity Add solvent slowly down the side of the vial to avoid direct contact with peptide cake Gently swirl or rock the vial for 5-10 minutes until fully dissolved Apply brief sonication if needed for complete dissolution Verify pH and filter through 0.22 m sterile filter if required Aliquot immediately into single-use volumes in low-binding tubes Snap freeze aliquots and store at -80C to prevent degradation Understanding Lyophilized Peptides Lyophilization removes water through freeze-drying, creating stable peptide formulations with extended shelf life

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Ghusn W, Hurtado MD

For all four peptides on Thursday's agenda BPC-157, TB-500, KPV, and MOTS-C FDA staff reviewed the evidence under the agency's four-part balancing test and reached the same conclusion for each: do not add them to the 503A Bulk Drug Substances List, the only legal pathway for compounding pharmacies to dispense these compounds to patients