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Because research-market material is sold outside any approved supply chain, its identity and purity are unverified: published trial data describe a characterized study drug, not the contents of an arbitrary vial, so identity confirmation (for example by mass spectrometry and HPLC) and a batch certificate of analysis are the minimum a rigorous research setting should require

doi: 10.1301/nr.2003.dec.397-412 28 VitekWAlurSHoegerKM

This is the central regulatory problem that full FDA approval would need to solve and it is the reason PCAC reviews for peptides like BPC-157 often hinge on available safety data rather than efficacy evidence from controlled human studies

Qiu et al