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Aseptic Preparation and Storage: Principles for Clinical Trial Settings Reconstitution of injectable investigational products must be performed by trained personnel following the trial protocol, using the specified diluent, in an appropriate aseptic environment

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Commercial products may vary in: Total milligrams per vial Tesamorelin-to-ipamorelin mass ratio Free base versus acetate content Excipients and stabilizers Actual net peptide content Sterility, endotoxin, and aggregate controls Equal milligrams do not mean equal molar exposure: Tesamorelin has a free-base molecular weight of approximately 5,135.9 Da, while ipamorelin is approximately 711.9 Da

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