Regulatory & Standards
14 entries.
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What ISO/IEC 17025 accreditation does and does not establish about a peptide testing laboratory
A laboratory logo on a certificate of analysis says little without its scope. This post reviews what ISO/IEC 17025 accreditation covers and where its limits lie.
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ALCOA+ and the analytical record: what data integrity means for the chromatogram behind a peptide purity figure
A purity percentage is the end of a chain of acquisition, integration and review. Data integrity principles describe what has to be true of that chain.
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Registered is not approved: the 503B outsourcing facility and the unit its status attaches to
Section 503B registration is a status held by a facility, not a clearance held by a product. That distinction governs what the designation can support.
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DSCSA and the serialized supply chain: what pharmaceutical traceability covers, and what sits outside it
The Drug Supply Chain Security Act traces prescription drugs in finished dosage form. Its statutory unit, its data elements, and its exclusions all matter.
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Import alerts and detention without physical examination: what a border refusal establishes, and what it does not
Detention without physical examination refuses entry on an appearance of violation, not a laboratory finding — and the difference governs what the record shows.
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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.