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Its diverse actions make it a valuable focus in clinical and medical studies

The COA should include HPLC purity data (target: 98% or higher), mass spectrometry confirmation of molecular identity, and ideally, endotoxin testing results

FDA reviewers, applying the statutory framework under 21 CFR 216.23(c), identified only one human study for BPC-157's proposed indication of ulcerative colitis: a decades-old meeting abstract that was never published as a peer-reviewed trial and that used an oral route of administration not the injectable or subcutaneous routes that wellness clinics commonly use

While research shows some benefits (for example improved sleep efficiency, reduced sleep latency) in controlled settings, there are still questions around long-term safety, especially in healthy subjects or non-clinical contexts

PMID 19491814

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