A peptide shelf-life or retest statement needs evidence for the actual material and conditions. An analysis date tells you when testing occurred; it does not supply an expiry period.
Keep the dates and periods separate
| Entry | Meaning to establish |
|---|---|
| Analysis date | When the reported measurements were performed |
| Report or approval date | When the document was issued or authorised |
| Shelf life or expiry | A supported period or endpoint under defined conditions |
| Retest period or date | When the specified reassessment is required |
ICH Q1A(R2) distinguishes shelf-life and retest terminology in its own defined scope. Here the terms are a reading aid, not an assignment of either period to a research reagent. Ask the supplier which definition and starting event apply.ICH Q1A(R2) — Stability terminology (opens in a new tab)
The supplied Semax example records analysis on 15–16 August and approval on 17 August 2026, without an expiry date. A later shipment date or a repeated passing test does not, by itself, establish a new supported period.Semax report (PDF) (opens in a new tab)ICH Q1A(R2) — Stability terminology (opens in a new tab)
Match the evidence to the material
Check identity, form or formulation, container and closure, storage conditions, studied lots and the attributes measured. Evidence for another form, package or condition does not automatically establish the same period for the material in hand.ICH Q1A(R2) — Stability terminology (opens in a new tab)
Chemical changes, physical changes and losses at interfaces can be different questions. The evidence should identify which property was measured and what counted as acceptable. A favourable assay alone does not replace relevant evidence for other specified attributes.ICH Q1E — Evaluation of stability data (opens in a new tab)
ICH Q1E describes assessing individual attributes and the limits they place on the overall period. Preserve the distinction between directly observed intervals and an extrapolated interval; a modelled extension needs its own justification.ICH Q1E — Evaluation of stability data (opens in a new tab)
Ask for the missing basis
Adding months to a date is calendar arithmetic after a supported period and starting event have been established. It cannot create the missing stability evidence. Follow the applicable supplied label and the existing storage-and-handling information; retain any unresolved duration as a question.ICH Q1A(R2) — Stability terminology (opens in a new tab)Storage and handling (opens in a new tab)
For an unexpected temperature event, record the product and lot, its documented conditions, the observed temperature information, the duration and any gaps in the record. Send those details with the relevant report when asking for clarification; the event record alone does not establish a revised expiry date.ICH Q1A(R2) — Stability terminology (opens in a new tab)Storage and handling (opens in a new tab)
Sources and further detail
- ICH Q1A(R2) — Stability terminology (opens in a new tab)
ICH Q1A(R2), glossary and stability-evidence scope; definitions used only as a reading aid.
- ICH Q1E — Evaluation of stability data (opens in a new tab)
ICH Q1E, assessment of separate attributes and evidence-supported periods; no period assigned to a Novum product.
- WHO — Model certificate of analysis (opens in a new tab)
Technical Report Series 1010, Annex 4 (2018). Background on report structure; not an endorsement of this material or certificate.
- Supplied Semax 10 mg certificate (opens in a new tab)
MA-SEM-0041, revision 01; task DMAS3J7; lot SEM-41-3J7. Source of the example, figures and document-specific observations. The cited PDF was re-read on 3 October 2026 to check this transcription; its issuer and findings were not independently authenticated.
- Novum Peptides — Storage and handling (opens in a new tab)
First-party label-directed storage information.
Revised from the existing source dossier on 3 October 2026. Supplied-report values are document transcriptions, not independent authentication or new measurements. Source notes identify the scope of each reference; this article has not undergone independent scientific peer review.