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Legal & Compliance
Every trustworthy peptide vial stands on a spec sheet — and that spec sheet traces back to one international guideline. ICH Q6B defines what identity, purity, and potency actually mean for proteins and polypeptides. This explainer unpacks the framework, its universal and specific tests, and why it shapes quality thinking even for research-grade material.
Legal & Compliance
Two vials with the same peptide name and the same listed purity can still belong to two completely different regulatory worlds. Research-grade and pharmacy-grade describe parallel supply chains with different rules about what gets tested, what gets documented, and who is accountable for what — and the gap shows up in the impurity profile, not the molecular weight.
Legal & Compliance
FDA's Pharmacy Compounding Advisory Committee will meet July 23-24, 2026 to discuss whether seven research peptides — BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, and Epitalon — should be added to the section 503A Bulks List. This research-use-only reference explains what the 503A Bulks List actually is, what's on the July 2026 agenda, the three nomination categories used during evaluation, the PCAC's advisory role versus FDA's final-decision authority, and what the outcomes mean — and don't mean — for research-grade peptide supply.