Regulatory & Standards
9 entries.
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The DMF reference on a peptide listing: what a Drug Master File is, and what invoking one would require
A Drug Master File is a confidential FDA submission that means something only inside a referencing drug application — not a quality grade a listing can claim.
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"GMP-grade" on a peptide listing: what ICH Q7 covers and where GMP actually begins
GMP is a claim about a manufacturer’s quality system, not a property of a molecule. Where that boundary falls in peptide synthesis, and why a CoA cannot show it.
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The 40-residue line: where a peptide stops being a drug and becomes a biologic
One number decides whether an amino acid polymer is regulated as a drug or a biological product. Where the 40-residue threshold came from and how it is counted.
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Impurity thresholds for synthetic peptides: the number underneath the purity figure
A purity result is a boundary. Threshold frameworks define how far below it anyone is obliged to look — and that definition changed for peptides in July 2026.
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The July 2026 PCAC meeting: seven peptides and how the 503A bulks list actually works
BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax and Epitalon went before FDA's compounding advisory committee. What that process does and does not decide.
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What "validated method" means on a peptide certificate: ICH Q2, verification, and the limits of system suitability
A certificate calling its purity method validated is making a narrowly scoped claim. What ICH Q2 requires, and why a passing system suitability run is not it.
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Residual solvents in synthetic peptides: what ICH Q3C covers, what it does not, and why headspace GC struggles with the ones that matter
Every peptide passes through DMF, piperidine, TFA and acetonitrile. The solvents most likely to remain are the ones the standard method is worst at seeing.
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Nitrosamine impurities in peptides: where NDSRIs come from and why routine testing does not look for them
Nitrosation needs a secondary amine and a nitrosating agent. Peptides supply both more often than expected, and the product is invisible to area-percent purity.
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FDA Peptide Enforcement: What 2026 Brought
The U.S. research peptide market underwent its biggest regulatory transition in a decade between late 2024 and early 2026.