References include the Ozempic, Wegovy, Zepbound, and Mounjaro FDA-approved prescribing information (latest revisions), USP General Chapter 797 (Pharmaceutical Compounding, Sterile Preparations), International Council for Harmonisation Q1A(R2) Stability Testing of New Drug Substances and Products, and Novo Nordisk and Eli Lilly published storage data
Lpez, B
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Although compounded medications are not FDA-approved, they must still meet USP standards for pharmaceutical compounding, which specify that once an expiration date is reached, the product cannot be guaranteed sterile or potent
HPLC alone cannot confirm peptide identity mass spectrometry is required to verify that the measured compound is actually the target peptide and not a co-eluting impurity with similar retention characteristics