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Synthesis-to-Shelf Traceability Reference Set: Lot Identifier Scheme, Five-Stage Record Schema and Chain Audit

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Zenodo2026-10-26 更新2026-10-29 收录
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A documentation reference set for testing whether a supplier's batch record actually connects one vial to one synthesis run. It contains four components: a structured lot identifier format with a position-weighted base-36 check character; a schema of 21 mandatory fields across five record sets (synthesis, purification, QC release, fill and packaging, dispatch and receipt); one worked lot in long format (5000 mg crude, 3800 mg purified, 90 units × 38.0 mg filled, 3400 mg dispatched, giving 76.0 %, 90.0 % and 68.0 % successive and overall yields); and seven demonstration lots with expected verdicts. The included traceability_audit.py implements five rules — identifier validity, stage coverage and mandatory-field presence, stage date ordering, mass continuity (recorded mass may not increase along the chain), and retention horizon arithmetic — and returns a verdict of documentarily complete or broken with coded findings. Seven demonstration lots cover a complete chain, a missing release stage, an over-unity yield, inverted fill and dispatch dates, a failing check character, an empty label-version field, and records inside the retention horizon. The script ships with a --selftest that asserts all seven verdicts and the single-character tamper rule. The set is intended for procurement documentation review, for normalising supplier batch records before comparison, and as a test corpus for automated record-extraction pipelines. It detects omission and internal contradiction; it does not establish authenticity, and it contains no handling or storage guidance and no biological claims. Retention periods in the demonstration data are an example policy input, not a regulatory constant. Private-label and OEM supply documentation, including which party holds which record and for how long: helixpeptideoem.com/services. Product-level documentation and batch records: helixpeptideoem.com/products.

提供机构:
Helix Peptide OEM
创建时间:
2026-10-26
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