Draft standard: determination of chromatographic purity by reverse-phase high-performance liquid chromatography
Consultation on the draft of the Institute's first analytical standard, which specifies the performance a chromatographic purity determination must achieve and states, without qualification, that the resulting figure is a relative ultraviolet area and not a…
§1Consultation and window
§1.1Window
- Opened
- 28 April 2023
- Closed
- 28 May 2023
- Duration
- 30 days
- Status
- Closed — the disposition is published
- Document under consultation
- Standard CEI-MS-01
- Submissions received
- 5
§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.
- Are the system suitability criteria appropriate across the range of peptide lengths and hydrophobicities in scope?
- Is the requirement to state the integration start time workable for laboratories operating validated legacy methods?
- Does the standard state clearly enough what a purity figure determined under it does not establish, in particular in relation to counter-ion content and to species that do not elute?
§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, principally to state performance rather than to prescribe a single gradient, and to carry a worked example showing the same chromatogram integrated two ways.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.