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

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

The risk: Most BPC-157 sold online is unregulated

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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