Draft standard CEI-MS-08: Related-substances profiling and the detection of isobaric impurities

§1Consultation and window

§1.1Window

Opened

6 November 2025

Closed

1 January 2026

Duration

56 days

Status

Closed — the disposition is published

Document under consultation

Standard CEI-MS-08

Submissions received

9

§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.

1. Are the system suitability criteria appropriate across the range of materials in scope?
2. Is the classification of any field as critical rather than recommended disproportionate?
3. Does the standard state clearly enough what a determination made under it does not establish?

§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

Amendments arising from the consultation were applied before ratification. Where the secretariat declined to accept a submission, the reason is recorded on the disposition page and the submission remains published in full.

The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.