Draft standard: freeze–thaw and in-use stability assessment of reconstituted peptide solutions
Consultation on the draft standard for freeze–thaw and in-use stability assessment of reconstituted peptide solutions. The draft specifies the cycling regime, the hold conditions and the stability-indicating determinations required, and records that a…
§1Consultation and window
§1.1Window
- Opened
- 13 April 2026
- Closed
- 25 May 2026
- Duration
- 42 days
- Status
- Closed — the disposition is published
- Document under consultation
- Standard CEI-MS-21
- Submissions received
- 15
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the freeze–thaw cycling regime representative of the handling a reconstituted solution actually receives?
- Should the standard require an aggregation determination alongside a purity determination, given that aggregated species may not be recovered from a reverse-phase column?
- Does the standard state clearly enough that an in-use stability result applies to the container, closure and diluent tested and to no other combination?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The standard was amended before ratification. An aggregation determination by size-exclusion chromatography is now required alongside the purity determination, and the dependence of an in-use result on the specific container and closure system is stated in the scope rather than in the limitations.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.